Summary: Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk evaluation and mitigation strategies; and (3) conducting screenings of the Adverse Event Reporting System database and reporting on new safety concerns.(Sec. 103) Reauthorizes prescription drug user fees beginning in FY2008. Requires the Secretary of Health and Human Services (the Secretary) to provide a partial refund of an applicant's user fees if the application is withdrawn without a waiver before filing.Sets forth special rules for positron emission tomography drugs, including subjecting an applicant in an approved human drug application for a positron emission tomography drug to one-sixth of the annual prescription drug establishment fee.Establishes the amount of revenue that fees are to generate for FY2008-FY2012. Requires that such fees be derived equally from fees related to human drug applications and supplements, prescription drug establishments, and prescription drug products. Sets forth provisions regarding adjustments to such fees. Authorizes appropriations for FY2008-FY2012.Exempts approved prescription drugs or licensed biological products designated for a rare disease or condition (orphan drugs) from product and establishment fees if certain requirements are met, including the that the drug is owned or licensed and marketed by a company having gross worldwide revenues that fall below a certain amount.(Sec. 104) Requires the Secretary to assess and collect fees for advisory review of proposed direct-to-consumer television advertisements of prescription drug products. Sets forth procedures for such review.Subjects each person that is assessed an advisory review fee to an operating reserve fee. Establishes the amount of revenue that may be generated from such fees. Requires the Secretary to annually set the advisory review fee. Sets forth fee limits.Terminates the advisory review program if revenue falls below a certain threshold.Authorizes appropriations for FY2008-FY2012.(Sec. 105) Requires the Secretary to report on the progress of the Food and Drug Administration (FDA) toward achieving goals related to expediting the drug development process and the process for the review of human drug applications.(Sec. 106) Terminates provisions related to prescription drug users fees and advisory review fees on October 1, 2012.Title II: Medical Device User Fee Amendments of 2007 - (Sec. 201) Medical Device User Fee Amendments of 2007 - Subtitle A: Fees Related to Medical Devices - (Sec. 211) Defines terms relating to fees for medical devices, including defining "30-day notice" as a notice of a supplement to an approved application that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and effectiveness of the device.(Sec. 212) Makes changes to medical device fees, including establishing a fee for: (1) a 30-day notice; (2) a request for classification information; and (3) periodic reporting for a class III device.Subjects each medical device establishment to a fee for each initial or annual registration beginning with its registration for FY2008, except for establishments operated by a state or federal governmental entity or an Indian tribe.Establishes the amount of revenue that may be generated from medical device fees. Makes changes to provisions related to qualifications for fee waivers for small businesses.Authorizes appropriations for FY2008-FY2012.(Sec. 213) Sets forth reporting requirements, including requiring the Secretary to report to the relevant congressional committees on the FDA's progress in achieving medical device review goals.(Sec. 215) Authorizes additional appropriations for FY2008-FY2012 to collect, develop, review, and evaluate postmarket safety information on medical devices.(Sec. 216) Makes amendments made by this title effective on the date of enactment of this title, except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notifications submissions received on or after October 1, 2007, regardless of such enactment date.(Sec. 217) Terminates amendments made by this title on October 1, 2012.Subtitle B: Amendments Regarding Regulation of Medical Devices - (Sec. 221) Extends the authority of accredited persons to review premarket reports for devices and make recommendations to the Secretary regarding the initial classification of devices.(Sec. 222) Requires any establishment within a foreign country engaged in the manufacturing, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States to annually register with the Secretary.(Sec. 223) Requires registered device producers to annually report to the Secretary with a list of new devices introduced by the registrant for commercial distribution, devices discontinued, a notice of resumption of processing of a device, and any material change in information previously submitted.(Sec. 224) Requires registrations and listings to be submitted to the Secretary electronically unless the Secretary grants a waiver of such requirement.(Sec. 225) Directs the Comptroller General to study the appropriate use of the process requiring registrants to report to the Secretary on the classification of a device before introduction of the device into interstate commerce.(Sec. 226) Requires the Secretary to promulgate regulations establishing a unique identification system for medical devices.(Sec. 227) Makes changes to reporting requirements for devices that have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.(Sec. 228) Requires a person accredited to conduct inspections of device establishments to notify the Secretary within 30 days of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems for any inspected establishment. Sets forth conditions that a device establishment must meet to be eligible for inspections by accredited persons.(Sec. 229) Directs the Comptroller General to study and report on nosocomial infections attributed to new and reused medical devices and the causes of such infections. Requires the Secretary, acting through the Commissioner of Food and Drugs, to determine whether: (1) the labeling requirements for indoor tanning devices provide sufficient information to consumers regarding the risks of irreversible damage to the eyes and skin, including skin cancer; (2) warning label modifications would communicate such risks more effectively; and (3) no warning would adequately communicate such risks.Title III: Pediatric Medical Device Safety and Improvement Act of 2007- (Sec. 301) Pediatric Medical Device Safety and Improvement Act of 2007 - (Sec. 302) Requires applications for a humanitarian device exemption, an application for premarket approval of a medical device, or a product development protocol for a medical device to include, if readily available: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Requires the Secretary to submit to the relevant congressional committees an annual report that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved; and (4) the review time for each approved device.Authorizes the Secretary to conclude that adult data on medical devices may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations if the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients.(Sec. 303) Excludes a person granted a humanitarian device exemption from the prohibition against selling such a medical device for an amount that exceeds its research and development, fabrication, and distribution costs if: (1) the device is intended to treat or diagnose a disease or condition that occurs in pediatric patients; (2) the device was not approved for pediatric patients prior to enactment of this Act; (3) the number of devices distributed does not exceed an annual distribution number specified by the Secretary; and (4) the request for exemption is submitted on or before October 1, 2012.Directs the Secretary to refer any adverse event report related to a device to the Office of Pediatric Therapeutics for review. Requires the Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, to provide for an annual review by the Pediatric Advisory Committee of all devices subject to the humanitarian device exemption to ensure that such exemption remains appropriate for the pediatric population for which it is granted.Directs the Comptroller General to report on the impact of allowing persons granted a humanitarian device exemption to profit from such a device.(Sec. 304) Requires the Secretary, acting through the Director of National Institutes of Health (NIH), to designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.Requires the Secretary, acting through the Commissioner, the Director of NIH, and the Director of the Agency for Healthcare Research and Quality, to report to the relevant congressional committees a plan for expanding pediatric medical device research and development.(Sec. 305) Requires the Secretary to award grants or contracts for demonstration projects to promote pediatric device development.Authorizes appropriations for FY2008-FY2012.(Sec. 306) Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Expands the duties of the advisory committee on pediatric therapeutics to include providing advice and recommendations on matters relating to medical devices.(Sec. 307) Allows the Secretary to require: (1) postmarket surveillance on class II or class III medical devices that are expected to have significant use in pediatric populations; (2) postmarket surveillance as a condition to approval or clearance of such devices; and (3) a prospective surveillance period of more than 36 months for such devices.Title IV: Pediatric Research Equity Act of 2007 - (Sec. 401) Pediatric Research Equity Act of 2007 - (Sec. 402) Requires an applicant seeking to defer submission of some or all pediatric assessments of the safety and effectiveness of a new drug or biological product to submit to the Secretary a timeline for the completion of pediatric studies. Sets forth annual reporting requirements for an applicant following the approval of such a deferral.Requires an applicant seeking a full or partial waiver of pediatric assessment submission requirements on the grounds that a pediatric formulation cannot be developed to submit to the Secretary documentation detailing why a pediatric formulation cannot be developed.Authorizes the Secretary to require submission of a pediatric assessment if the Secretary finds that: (1) adequate pediatric labeling could confer a benefit on pediatric patients; or (2) the absence of adequate pediatric labeling could pose a risk (currently, significant risk) to pediatric patients.Directs the Secretary to utilize an internal committee to consult with reviewing divisions on: (1) all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required; and (2) all deferral and waiver requests granted.Requires the Secretary to track and make publicly available information related to pediatric assessments, including: (1) the number of assessments conducted; (2) the specific drugs and biological products and uses assessed; (3) the number of deferrals requested and granted; (4) the labeling changes made as a result of such assessments; and (5) the internal committee's recommendations for priority review. Requires the Secretary to: (1) order the label of a product to include information about the results of the assessment and a statement that a pediatric assessment does or does not demonstrate that the drug is safe and effective in pediatric populations; (2) make publicly available the pharmacology reviews of pediatric assessments; (3) require the sponsors of the assessments that result in labeling changes to distribute such information to physicians and other heath care providers; and (4) ensure that all adverse event reports that have been received for a drug are referred to the Office of Pediatric Therapeutics for review.Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies and the labeling changes made as a result of such studies.(Sec. 403) Requires the Secretary to establish an internal committee to review written requests for pediatric studies and to provide consultation to reviewing divisions on all pediatric plans and assessments.(Sec. 404) Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of specified pediatric research provisions in ensuring that medicines used by children are tested and properly labeled.Title V: Best Pharmaceuticals for Children Act of 2007 - (Sec. 501) Best Pharmaceuticals for Children Act of 2007 - (Sec. 502) Amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding market exclusivity for pediatric drug studies on new or already approved drugs, including to: (1) change the definition of "pediatric studies" to authorize the Secretary to include preclinical studies; (2) require the studies to be completed using appropriate formulations for each age group for which such a study is requested; and (3) prohibit the Secretary from extending the period of market exclusivity later than nine months prior to the expiration of the period.Requires an applicant or holder that does not agree to the request for a pediatric study to submit to the Secretary the reasons such pediatric formulations cannot be developed. Requires an applicant or holder that agrees to such a request to provide the Secretary with all postmarket adverse event reports regarding the drug. Extends to 180 days (currently, 90 days) the period the Secretary has to accept or reject reports on pediatric studies and notify the sponsor or holder.Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if the pediatric formulation is not introduced onto the market within one year after the determination regarding market exclusivity; (2) utilize the internal review committee to review all written requests for pediatric studies issued; (3) track and make publicly available information on the pediatric studies conducted; (4) order the labeling of a product to include information about the results of the study and a statement that a pediatric study does or does not demonstrate that the drug is safe and effective in pediatric populations; and (5) ensure that all adverse event reports that have been received for a drug are referred to the Office of Pediatric Therapeutics.Sets forth actions for the Secretary to take if pediatric studies have not been completed and there is a continuing need for information relating to the use of the drug in the pediatric population.Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding written requests for pediatric studies made and the studies conducted.Requires the Secretary, acting through the Director of NIH, to: (1) develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that need study; and (2) study and report to Congress on the feasibility of establishing a compilation of information on pediatric drug use.Authorizes appropriations.Authorizes the Foundation for the National Institutes of Health to solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of activities relating to studies on the Secretary's priority list of needs in pediatric therapeutics and for which the Secretary determines that an assessment is required. Amends the Best Pharmaceuticals for Children Act to require the advisory committee on pediatric therapeutics to continue to operate for five years after enactment of this Act. Requires the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to: (1) provide recommendations to the internal review committee that reviews pediatric research requests with respect to the treatment of pediatric cancer; and (2) continue to operate for five years after enactment of this Act. Sets forth reporting requirements.Directs that the proposed rule issued by the Commissioner entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" take effect on January 1, 2008, unless the final rule is issued before such date. (Sec. 503) Requires the Director of the National Institute of Child Health and Human Development to include health professionals who intend to build careers in pediatric pharmacological research within the Institute's career development activities.Includes pediatric pharmacological research within the pediatric research loan repayment program.Title VI: Reagan-Udall Foundation - (Sec. 601) Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Requires the Foundation to: (1) identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness of such products; (2) establish goals and priorities; (3) identify federal research and development programs and minimize duplication; (4) award grants to scientists and entities to efficiently and effectively advance such goals and priorities; and (5) provide objective clinical and scientific information to the FDA and other federal agencies.Directs the FDA Commissioner to transfer specified funds to the Foundation each fiscal year, and authorizes the Foundation's Executive Director to solicit and accept funds and gifts, including from private entities, for the purposes of carrying out the Foundation's duties.(Sec. 602) Requires the Secretary to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4) develop a peer review process by which intramural research can be evaluated; (5) identify and solicit intramural research proposals from across the FDA; and (6) develop additional postmarket safety performance measures.(Sec. 603) Authorizes the Secretary, acting through the Commissioner, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the FDA by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, manufacturing, and translational therapeutics, and enhance medical product safety. Authorizes appropriations for FY2009-FY2012. Title VII: Conflicts of Interest - (Sec. 701) Directs the Secretary to: (1) develop and implement strategies on effective outreach to potential members of advisory committees; and (2) review the expertise and financial disclosure report of an individual when considering an appointment to an advisory committee. Prohibits any member of an advisory committee from participating with respect to any matter in which the member has a financial interest, unless such member is granted a waiver by the Secretary to afford the advisory committee essential expertise. Limits the number of waivers that may be granted in FY2008 through FY2012 to a specified decreasing percentage of the number granted in 2007 and requires specified disclosures regarding the financial interests of members receiving waivers.Title VIII: Clinical Trials Databases - (Sec. 801) Amends the Public Health Service Act to require the Secretary, acting through the Director of NIH, to expand the clinical trials registry data bank. Requires the Director to ensure that the data bank is made publicly available through the Internet. Specifies information required to be submitted for an applicable clinical trial and included in the data bank. Requires the Secretary to ensure that the data bank includes links to results information for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug or device involved is approved or cleared. Requires the Secretary to further expand the registry and results data bank to provide more complete results information and enhance patient access to and understanding of the results of clinical trials within three years after enactment of this Act. Prohibits the failure to submit required clinical trial information or the submission of false or misleading clinical trial information to the data bank. Sets forth civil penalties for violations.Prohibits a state or political subdivision from establishing or continuing in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database after the required expansion of the data bank three years after enactment of this Act.Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs - Subtitle A: Postmarket Studies and Surveillance - (Sec. 901) Prohibits a responsible person from introducing into interstate commerce a new drug if the person is in violation of a requirement related to postapproval clinical trials or labeling changes.Authorizes the Secretary to: (1) require a responsible person for a drug to conduct a postapproval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk; (2) require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware of new safety information; and (3) issue an order directing a responsible person or holder of an approved application to make a labeling change to address new safety information. Sets forth procedures for dispute resolution.Prohibits a person from introducing into interstate commerce a new drug or biological product for which a risk evaluation and mitigation strategy is required if the person fails to maintain compliance with the requirements of such strategy.Requires a person to submit a risk evaluation and mitigation strategy as part of the application if determined necessary to ensure that the benefits of the drug involved outweigh the risks. Sets forth factors the Secretary must consider in making such a determination.Requires a proposed risk evaluation and management strategy to include a timetable for assessment of the strategy. Allows the Secretary to require such a strategy to include additional elements, including: (1) distribution to each patient of a Medication Guide and a patient package insert; (2) a communication plan to health care providers; and (3) assurances of safe use.Establishes the Drug Safety Oversight Board.Authorizes the Secretary to: (1) require the submission of any television advertisement for a drug for review before dissemination; (2) make recommendations with respect to information included in the label of the drug or on statements for inclusion in advertisements but not require changes in such advertisements; and (3) require inclusion in advertisements of certain disclosures about a serious risk listed in the labeling of the drug. (Sec. 902) Deems to be misbranded a drug: (1) subject to an approved risk evaluation and mitigation strategy if the responsible person fails to comply with the strategy's requirements; or (2) if the responsible person is in violation of a requirement relating to postmarket studies and clinical trials or labeling.(Sec. 903) Authorizes the Secretary to withdraw or suspend the approval of a new drug application without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy.(Sec. 904) Directs the Commissioner to report to Congress on how best to communicate to the public the risks and benefits of new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits.(Sec. 905) Requires the Secretary to develop validated methods for the establishment of a postmarket risk identification and analysis system. Directs the Secretary to establish and maintain procedures: (1) for risk identification and analysis based on electronic health data; (2) for the reporting of data on all serious adverse drug experiences; (3) to provide for active adverse event surveillance using federal and private health-related electronic data and other data as the Secretary deems necessary; (4) to identify certain trends and patterns with respect to data accessed by the system; and (5) to provide regular reports to the Secretary regarding adverse events. Requires the Comptroller General to evaluate data privacy, confidentiality, and security issues relating to accessing, transmitting, and maintaining data for the active postmarket risk identification and analysis system under this Act and make recommendations to relevant congressional committees regarding the need for any additional legislative or regulatory actions to ensure privacy, confidentiality, and security.(Sec. 906) Deems a drug or device to be misbranded if published direct-to-consumer advertisements do not include a specified statement related to reporting negative side effects.(Sec. 908) Authorizes appropriations for FY2008-FY2012.(Sec. 909) Deems drugs approved before the effective date of this Act to have an approved risk evaluation and mitigation strategy if there are in place elements to assure safe use of such drug. Subtitle B: Other Provisions to Ensure Drug Safety and Surveillance (Sec. 911) Requires the Secretary to issue guidance for the conduct of clinical trials with respect to antibiotic drugs.(Sec. 912) Prohibits the introduction into interstate commerce of any food to which has been added an approved drug, a licensed biological product, or certain other drugs or biological products unless: (1) such drug or biological product was marketed in food prior to approval, licensure, or clinical investigation; (2) the Secretary has issued a regulation approving the use of such drug or biological product in the food; (3) the use of the drug or the biological product is to enhance the safety of the food and not to have independent biological or therapeutic effects on humans and the use is in conformity with specified regulations; or (4) the drug is a new animal drug whose use is not unsafe.(Sec. 913) Requires the Secretary to: (1) develop standards to secure the drug supply chain against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs; (2) prioritize and develop standards for the identification, validation, authentication, tracking, and tracing of prescription drugs; (3) develop a standardized numerical identifier for prescription drugs; and (4) expand and enhance resources and facilities for enforcement of this Act to secure the drug supply chain.(Sec. 914) Prohibits the Secretary from delaying approval of a pending application on the basis of a citizen petition unless the Secretary determines that a delay is necessary to protect the public health. (Sec. 915) Requires the Secretary to improve the transparency of information about drugs and allow patients and health care providers better access to such information by developing and maintaining a website that: (1) provides links to drug safety information for approved prescription drugs; and (2) improves communication of drug safety information to patients and providers. Requires the Advisory Committee on Risk Communication to: (1) regularly perform a comprehensive review and evaluation of the types of risk communication information provided on such website; and (2) recommend ways for the FDA to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers. (Sec. 916) Requires that certain information related to a new drug application be published on the FDA's website, including: (1) documents generated by the FDA related to review of an application; and (2) a summary review of conclusions from all reviewing disciplines about the drug. Provides that a scientific review of an application is considered the work of the reviewer. Prohibits the altering of such work by management or the reviewer once it is final. (Sec. 917) Requires the Secretary to establish the Advisory Committee on Risk Communication to advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the FDA.Directs the Secretary to partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multifaceted systems for communication to health care providers about emerging postmarket drug risks.(Sec. 918) Requires the Secretary to refer a drug of which no active ingredient has been approved in any other application to an FDA advisory committee for review prior to approval or provide a summary of the reasons why the Secretary did not refer the drug. (Sec. 919) Requires the Secretary to issue a report responding to the Institute of Medicine report on drug safety.(Sec. 920) Directs the Commissioner to publish and update, quarterly, a complete list of all authorized generic drugs on the FDA's website.(Sec. 921) Requires the Secretary to: (1) conduct regular, biweekly screening of the Adverse Event Reporting System database and post a report on the Adverse Event Reporting System website of any new safety information or any potential signal of a serious risk identified by the System within the last quarter; (2) report to Congress on FDA processes and procedures to address ongoing postmarket safety issues identified by the Office of Surveillance and Epidemiology and on how such recommendations are handled within the FDA; and (3) review annually the entire backlog of postmarket safety commitments to determine which commitments require revision or should be eliminated, report to Congress on such determinations, and assign start dates and estimated completion dates for such commitments.Title X: Food Safety - (Sec. 1002) Requires the Secretary to establish: (1) ingredient standards and definitions with respect to pet food; (2) processing standards for pet food; and (3) updated standards for pet food labeling that include nutritional and ingredient information.Requires the Secretary to establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food.(Sec. 1003) Requires the Secretary, during an ongoing recall of human or pet food regulated by the Secretary, to: (1) work with companies, professional associations, and other organizations to collect and aggregate pertinent information; (2) use existing networks of communication to enhance the quality and speed of communication with the public; and (3) post information regarding recalled human and pet foods on the FDA's website in a single location.(Sec. 1004) Requires the Secretary to work with states in undertaking activities that assist in improving the safety of food, including fresh and processed produce.(Sec. 1005) Requires the Secretary to: (1) establish a Reportable Food Registry to which instances of reportable food may be submitted by the FDA; and (2) issue an alert or a notification using information from the Registry as the Secretary deems necessary to protect the public health. Requires a responsible party who determines that an article of food is a reportable food to: (1) submit a report to the FDA within 24 hours; and (2) investigate the cause of the adulteration if the adulteration may have originated with the responsible party.Requires the Secretary to immediately notify the Secretary of Homeland Security if the Secretary believes food reported to the Registry may have been deliberately adulterated.(Sec. 1006) Authorizes the Secretary to enhance, as necessary, the inspection regime of the FDA for aquaculture and seafood, consistent with U.S. obligations under international agreements and U.S. law.(Sec. 1007) Requires the Commissioner to produce a report on any environmental risks associated with genetically engineered seafood products.(Sec. 1008) Expresses the sense of Congress that: (1) it is vital for Congress to provide the FDA with additional resources, authorities, and direction to ensure the safety of the U.S. food supply; (2) the Secretary should make it a priority to enter into agreements with U.S. trading partners with respect to food safety; and (3) Congress should work to develop a comprehensive response to the issue of food safety.(Sec. 1009) Sets forth reporting requirements with respect to food products regulated by the FDA.(Sec. 1010) Requires the Commissioner to annually submit to Congress and publish on the FDA's website a report concerning the results of the FDA's pesticide residue monitoring program.Title XI: Other Provisions - Subtitle A: In General (Sec. 1101) Requires the Secretary, through the Commissioner, to establish and make publicly available clear written policies to govern the timely submission, review, clearance, and disclaimer requirements for publication of articles by an FDA officer or employee.(Sec. 1102) Requires the Secretary to: (1) award a transferable, priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such application; and (2) establish a priority review user fee program.(Sec. 1103) Requires the Secretary to enter into a contract with the Institute of Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve federal oversight and regulation of genetic tests. Subtitle B: Antibiotic Access and Innovation (Sec. 1111) Requires the Secretary, through the Commissioner, to identify and periodically update clinically susceptible concentrations (specific values that characterize bacteria as clinically susceptible, intermediate, or resistant to the drug tested).(Sec. 1112) Directs the Commissioner to convene a public meeting regarding which serious and life threatening infectious diseases potentially qualify for available grants and contracts under the Orphan Drug Act or other incentives for development.Amends the Orphan Drug Act to reauthorize appropriations for grants and contracts to defray the costs of: (1) qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions, (2) developing medical devices for rare diseases or conditions, and (3) developing medical foods for rare diseases or conditions.(Sec. 1113) Allows an applicant for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application to elect to have the single enantiomer considered the same active ingredient as that contained in the approved racemic drug under certain circumstances.(Sec. 1114) Direct the Comptroller General to submit a report to the relevant congressional committees that examines whether and how this subtitle has: (1) encouraged the development of new antibiotics and other drugs; and (2) prevented or delayed timely generic entry into the market.

title prescription drug user fee amendments sec prescription drug user fee amendments sec amends cosmetic act ffdca include postmarket safety activities process review human drug applications supplements including developing improved adverse event data collection systems improved analytical tools assess potential safety problems implementing enforcing provisions relating studies clinical trials labeling changes risk evaluation mitigation strategies conducting screenings database reporting new safety reauthorizes prescription drug user fees beginning fy2008 requires secretary health_and_human_services secretary provide partial refund applicant user fees application withdrawn waiver filing sets forth special rules positron emission tomography drugs including subjecting applicant approved human drug application positron emission tomography drug sixth annual prescription drug establishment fee establishes revenue fees generate fy2008 fy2012 requires fees derived equally fees related human drug applications supplements prescription drug establishments prescription drug products sets forth provisions adjustments fees authorizes appropriations fy2008 approved prescription drugs licensed biological products designated rare disease condition orphan drugs product establishment fees certain requirements met including drug owned licensed marketed company having gross worldwide revenues fall certain requires secretary assess collect fees advisory review proposed direct consumer television advertisements prescription drug products sets forth procedures review subjects person assessed advisory review fee operating reserve fee establishes revenue generated fees requires secretary annually set advisory review fee sets forth fee limits terminates advisory review program revenue falls certain threshold authorizes appropriations fy2008 requires secretary report progress food_and_drug_administration fda achieving goals related expediting drug development process process review human drug terminates provisions related prescription drug users fees advisory review fees october medical device user fee amendments sec medical device user fee amendments subtitle fees related medical devices sec defines terms relating fees medical devices including defining day notice notice supplement approved application limited request modifications manufacturing procedures methods affecting safety effectiveness makes changes medical device fees including establishing fee day notice request classification information periodic reporting class iii device subjects medical device establishment fee initial annual registration beginning registration fy2008 establishments operated state federal governmental entity indian tribe establishes revenue generated medical device fees makes changes provisions related qualifications fee waivers small businesses authorizes appropriations fy2008 sets forth reporting requirements including requiring secretary report relevant congressional committees fda progress achieving medical device review authorizes additional appropriations fy2008 fy2012 collect develop review evaluate postmarket safety information medical makes amendments title effective date enactment title fees shall assessed premarket applications premarket reports supplements premarket notifications submissions received october regardless enactment terminates amendments title october amendments regulation medical devices sec extends authority accredited persons review premarket reports devices recommendations secretary initial classification requires establishment foreign country engaged manufacturing propagation compounding processing drug device imported offered import united_states annually register requires registered device producers annually report secretary list new devices introduced registrant commercial distribution devices discontinued notice resumption processing device material change information previously requires registrations listings submitted secretary electronically secretary grants waiver directs comptroller general study appropriate use process requiring registrants report secretary classification device introduction device interstate requires secretary promulgate regulations establishing unique identification system medical makes changes reporting requirements devices likely cause contribute death injury requires person accredited conduct inspections device establishments notify secretary days withdrawal suspension restriction expiration certificate conformance quality systems inspected establishment sets forth conditions device establishment meet eligible inspections accredited directs comptroller general study report infections attributed new medical devices causes infections requires secretary acting commissioner food_and_drugs determine labeling requirements indoor tanning devices provide sufficient information consumers risks irreversible damage eyes skin including skin cancer warning label modifications communicate risks effectively warning adequately communicate risks title iii pediatric medical device safety improvement act sec pediatric medical device safety improvement act sec requires applications humanitarian device exemption application premarket approval medical device product development protocol medical device include readily available description pediatric subpopulations suffer disease condition device intended treat diagnose cure number affected pediatric patients requires secretary submit relevant congressional committees annual report includes number devices approved preceding year pediatric subpopulation suffers disease number approved devices labeled use pediatric patients number fee exempt devices approved review time approved device authorizes secretary conclude adult data medical devices support determination reasonable assurance effectiveness pediatric populations course disease condition effects device sufficiently similar adults pediatric excludes person granted humanitarian device exemption prohibition selling medical device exceeds research development fabrication distribution costs device intended treat diagnose disease condition occurs pediatric patients device approved pediatric patients prior enactment act number devices distributed exceed annual distribution number specified secretary request exemption submitted october secretary refer adverse event report related device office_of_pediatric_therapeutics review requires secretary acting office_of_pediatric_therapeutics center_for_devices_and_radiological_health provide annual review pediatric_advisory_committee devices subject humanitarian device exemption ensure exemption remains appropriate pediatric population granted directs comptroller general report impact allowing persons granted humanitarian device exemption profit requires secretary acting director national_institutes_of_health nih designate contact point office help innovators physicians identify sources funding available pediatric medical device development requires secretary acting commissioner director nih director agency healthcare_research quality report relevant congressional committees plan expanding pediatric medical device research requires secretary award grants contracts demonstration projects promote pediatric device development authorizes appropriations fy2008 includes duty office_of_pediatric_therapeutics increasing pediatric access medical devices expands duties advisory committee pediatric include providing advice recommendations matters relating medical allows secretary require postmarket surveillance class class iii medical devices expected significant use pediatric populations postmarket surveillance condition approval clearance devices prospective surveillance period months devices title pediatric research equity act sec pediatric research equity act sec requires applicant seeking defer submission pediatric assessments safety effectiveness new drug biological product submit secretary timeline completion pediatric studies sets forth annual reporting requirements applicant following approval deferral requires applicant seeking partial waiver pediatric assessment submission requirements grounds pediatric formulation developed submit secretary documentation detailing pediatric formulation developed authorizes secretary require submission pediatric assessment secretary finds adequate pediatric labeling confer benefit pediatric patients absence adequate pediatric labeling pose risk currently significant risk pediatric patients directs secretary utilize internal committee consult reviewing divisions pediatric plans assessments prior approval application supplement pediatric assessment required deferral waiver requests granted requires secretary track publicly available information related pediatric assessments including number assessments conducted specific drugs biological products uses assessed number deferrals requested granted labeling changes result assessments internal committee recommendations priority review requires secretary order label product include information results assessment statement pediatric assessment demonstrate drug safe effective pediatric populations publicly available pharmacology reviews pediatric assessments require sponsors assessments result labeling changes distribute information physicians heath care providers ensure adverse event reports received drug referred office_of_pediatric_therapeutics review requires secretary contract institute_of_medicine study report congress pediatric studies labeling changes result requires secretary establish internal committee review written requests pediatric studies provide consultation reviewing divisions pediatric plans requires comptroller general submit report congress addresses effectiveness specified pediatric research provisions ensuring medicines children tested properly labeled title best pharmaceuticals children act sec best pharmaceuticals children act sec amends cosmetic act revise provisions market exclusivity pediatric drug studies new approved drugs including change definition pediatric studies authorize secretary include preclinical studies require studies completed appropriate formulations age group study requested prohibit secretary extending period market exclusivity later months prior expiration period requires applicant holder agree request pediatric study submit secretary reasons pediatric formulations developed requires applicant holder agrees request provide secretary postmarket adverse event reports drug extends days currently days period secretary accept reject reports pediatric studies notify sponsor holder directs secretary publish notice identifying drug pediatric formulation developed studied found safe effective pediatric population pediatric formulation introduced market year determination market exclusivity utilize internal review committee review written requests pediatric studies issued track publicly available information pediatric studies conducted order labeling product include information results study statement pediatric study demonstrate drug safe effective pediatric populations ensure adverse event reports received drug referred office_of_pediatric_therapeutics sets forth actions secretary pediatric studies completed continuing need information relating use drug pediatric population requires secretary contract institute_of_medicine study report congress written requests pediatric studies studies conducted requires secretary acting director nih develop publish priority list needs pediatric including drugs indications need study study report congress feasibility establishing compilation information pediatric drug use authorizes appropriations authorizes foundation national_institutes_of_health solicit accept gifts grants donations establish accounts invest expend funds support activities relating studies secretary priority list needs pediatric secretary determines assessment required amends require advisory committee pediatric continue operate years enactment act requires provide recommendations internal review committee reviews pediatric research requests respect treatment pediatric cancer continue operate years enactment act sets forth reporting requirements directs proposed rule issued commissioner entitled toll free number reporting adverse events labeling human drug products effect january final rule issued date sec requires director include health professionals intend build careers pediatric pharmacological research institute career development activities includes pediatric pharmacological research pediatric research loan repayment program title sec establishes reagan udall foundation food_and_drug_administration nonprofit corporation advance mission fda modernize medical veterinary food food ingredient cosmetic product development accelerate innovation enhance product safety requires foundation identify unmet needs development manufacture evaluation safety effectiveness products establish goals priorities identify federal research development programs minimize duplication award grants scientists entities efficiently effectively advance goals priorities provide objective clinical scientific information fda federal agencies directs fda commissioner transfer specified funds foundation fiscal year authorizes foundation executive director solicit accept funds gifts including private entities purposes carrying foundation requires secretary establish office chief scientist oversee coordinate ensure quality regulatory focus fda intramural research programs track coordinate intramural research awards fda center science based office develop advocate budget support intramural research develop peer review process intramural research evaluated identify solicit intramural research proposals fda develop additional postmarket safety performance authorizes secretary acting commissioner enter critical path public private partnerships eligible entities implement critical path initiative fda developing research education outreach projects foster medical product innovation accelerate medical product development manufacturing translational enhance medical product safety authorizes appropriations fy2009 fy2012 title vii conflicts interest sec directs secretary develop implement strategies effective outreach potential members advisory committees review expertise financial disclosure report individual considering appointment advisory committee prohibits member advisory committee participating respect matter member financial interest member granted waiver secretary afford advisory committee essential expertise limits number waivers granted fy2008 fy2012 specified decreasing percentage number granted requires specified disclosures financial interests members receiving waivers title viii sec amends public_health_service_act require secretary acting director nih expand clinical trials registry data bank requires director ensure data bank publicly available internet specifies information required submitted applicable clinical trial included data bank requires secretary ensure data bank includes links results information clinical trials form primary basis efficacy claim conducted drug device involved approved cleared requires secretary expand registry results data bank provide complete results information enhance patient access understanding results clinical trials years enactment act prohibits failure submit required clinical trial information submission false misleading clinical trial information data bank sets forth civil penalties violations prohibits state political subdivision establishing continuing effect requirement registration clinical trials inclusion information relating results clinical trials database required expansion data bank years enactment act title postmarket studies surveillance sec prohibits responsible person introducing interstate commerce new drug person violation requirement related clinical trials labeling changes authorizes secretary require responsible person drug conduct study clinical trial drug assess known risk signals risk identify unexpected risk require study clinical trial approved drug secretary aware new safety information issue order directing responsible person holder approved application labeling change address new safety information sets forth procedures dispute resolution prohibits person introducing interstate commerce new drug biological product risk evaluation mitigation strategy required person fails maintain compliance requirements strategy requires person submit risk evaluation mitigation strategy application determined necessary ensure benefits drug involved outweigh risks sets forth factors secretary consider making determination requires proposed risk evaluation management strategy include timetable assessment strategy allows secretary require strategy include additional elements including distribution patient patient package insert communication plan health care providers assurances safe use establishes drug safety oversight board authorizes secretary require submission television advertisement drug review dissemination recommendations respect information included label drug statements inclusion advertisements require changes advertisements require inclusion advertisements certain disclosures risk listed labeling drug sec deems misbranded drug subject approved risk evaluation mitigation strategy responsible person fails comply strategy requirements responsible person violation requirement relating postmarket studies clinical trials authorizes secretary withdraw suspend approval new drug application ordering applicant submit assessment approved risk evaluation mitigation directs commissioner report congress best communicate public risks benefits new drugs role risk evaluation mitigation strategy assessing risks requires secretary develop validated methods establishment postmarket risk identification analysis system directs secretary establish maintain procedures risk identification analysis based electronic health data reporting data adverse drug experiences provide active adverse event surveillance federal private health related electronic data data secretary deems necessary identify certain trends patterns respect data accessed system provide regular reports secretary adverse events requires comptroller general evaluate data privacy confidentiality security issues relating accessing transmitting maintaining data active postmarket risk identification analysis system act recommendations relevant congressional committees need additional legislative regulatory actions ensure privacy confidentiality deems drug device misbranded published direct consumer advertisements include specified statement related reporting negative authorizes appropriations fy2008 deems drugs approved effective date act approved risk evaluation mitigation strategy place elements assure safe use drug subtitle requires secretary issue guidance conduct clinical trials respect antibiotic prohibits introduction interstate commerce food added approved drug licensed biological product certain drugs biological products drug biological product marketed food prior approval licensure clinical investigation secretary issued regulation approving use drug biological product food use drug biological product enhance safety food independent biological therapeutic effects humans use conformity specified regulations drug new animal drug use requires secretary develop standards secure drug supply chain counterfeit diverted substandard adulterated misbranded expired drugs prioritize develop standards identification validation authentication tracking tracing prescription drugs develop standardized numerical identifier prescription drugs expand enhance resources facilities enforcement act secure drug supply prohibits secretary delaying approval pending application basis citizen petition secretary determines delay necessary protect public health sec requires secretary improve transparency information drugs allow patients health care providers better access information developing maintaining website provides links drug safety information approved prescription drugs improves communication drug safety information patients providers requires regularly perform comprehensive review evaluation types risk communication information provided website recommend ways fda work outside entities help facilitate dispensing risk communication information patients providers sec requires certain information related new drug application published fda website including documents generated fda related review application summary review conclusions reviewing disciplines drug provides scientific review application considered work reviewer prohibits altering work management reviewer final sec requires secretary establish advise commissioner methods effectively communicate risks associated products regulated secretary partner professional medical societies medical schools academic medical centers stakeholders develop robust systems communication health care providers emerging postmarket drug requires secretary refer drug active ingredient approved application fda advisory committee review prior approval provide summary reasons secretary refer drug sec requires secretary issue report responding institute_of_medicine report drug directs commissioner publish update quarterly complete list authorized generic drugs fda requires secretary conduct regular biweekly screening database post report website new safety information potential signal risk identified system quarter report congress fda processes procedures address ongoing postmarket safety issues identified recommendations handled fda review annually entire backlog postmarket safety commitments determine commitments require revision eliminated report congress determinations assign start dates estimated completion dates commitments title food safety sec requires secretary establish ingredient standards definitions respect pet food processing standards pet food updated standards pet food labeling include nutritional ingredient information requires secretary establish early warning surveillance system identify adulteration pet food supply outbreaks illness associated pet requires secretary ongoing recall human pet food regulated secretary work companies professional associations organizations collect aggregate pertinent information use existing networks communication enhance quality speed communication public post information recalled human pet foods fda website single requires secretary work states undertaking activities assist improving safety food including fresh processed requires secretary establish instances reportable food submitted fda issue alert notification information registry secretary deems necessary protect public health requires responsible party determines article food reportable food submit report fda hours investigate cause adulteration adulteration originated responsible party requires secretary immediately notify secretary homeland_security secretary believes food reported registry deliberately authorizes secretary enhance necessary inspection regime fda aquaculture seafood consistent obligations international agreements requires commissioner produce report environmental risks associated genetically engineered seafood expresses sense congress vital congress provide fda additional resources authorities direction ensure safety food supply secretary priority enter agreements trading partners respect food safety congress work develop comprehensive response issue food sets forth reporting requirements respect food products regulated requires commissioner annually submit congress publish fda website report concerning results fda pesticide residue monitoring program title provisions subtitle general sec requires secretary commissioner establish publicly available clear written policies govern timely submission review clearance disclaimer requirements publication articles fda officer requires secretary award transferable priority review voucher sponsor tropical disease product application approval secretary application establish priority review user fee requires secretary enter contract institute_of_medicine conduct study assess overall safety quality genetic tests prepare report includes recommendations improve federal oversight regulation genetic tests subtitle requires secretary commissioner identify periodically update clinically susceptible concentrations specific values characterize bacteria clinically susceptible intermediate resistant drug directs commissioner convene public meeting life threatening infectious diseases potentially qualify available grants contracts orphan drug act incentives development amends orphan drug act reauthorize appropriations grants contracts defray costs qualified testing expenses incurred connection development drugs rare diseases conditions developing medical devices rare diseases conditions developing medical foods rare diseases allows applicant non drug containing active ingredient single contained drug approved application elect single considered active ingredient contained approved drug certain direct comptroller general submit report relevant congressional committees examines subtitle encouraged development new antibiotics drugs prevented delayed timely generic entry market


Summary: Everson Walls and Ron Springs Gift for Life Act of 2007 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries 24 hours a day; (3) ensure that funded registries comply with requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse.Requires the Secretary to award grants or cooperative agreements to eligible entities for such registries. Requires recipients to agree to establish benchmarks for improvement in organ and tissue donation and to maintain registries that: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death, 24 hours a day; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent.Directs the Comptroller General to study and report to Congress on the feasibility of establishing a living donor database to track short- and long-term health effects for donors associated with living organ donation.

life act amends public_health_service_act direct secretary health_and_human_services acting administrator health_resources_and_services_administration establish shall advance development expansion evaluation state organ tissue donor registries facilitate timely access exchange accurate donor information registries hours day ensure funded registries comply requirements provide technical assistance states registries maintain registry information clearinghouse requires secretary award grants cooperative agreements eligible entities registries requires recipients agree establish benchmarks improvement organ tissue donation maintain registries allow donor include statement symbol donor amended revoked gift allow organ procurement organizations access information near donor death hours day bar use disclosure personally identifiable information purpose donor consent directs comptroller_general study report congress feasibility establishing living donor database track short- long term health effects donors associated living organ donation


Summary: Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.

amends cosmetic act establish criminal fine imprisonment person knowingly causes prescription drug adulterated misbranded misrepresented approved prescription drug sells trades drug purchases trades drug knowing having reason know drug knowingly adulterated misbranded misrepresented requires manufacturer drug notify secretary health_and_human_services hours receiving aware information reasonably suggests violation occurred deems drug misbranded manufactured accordance use technologies secretary determines technically feasible assist preventing violations requires secretary establish alternative requirements extent requirements provide greater certainty chain custody technically feasible increases funding food_and_drug_administration fda inspections examinations investigations requires secretary educate public health care professionals counterfeit drugs directs secretary finding reasonable probability drug intended human use cause health consequences death issue order requiring appropriate person including manufacturers importers distributors retailers drug cease distribution drug notify instruct health professionals cease administering prescribing drug amend order include recall necessary


Summary: Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements.Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress.

amends cosmetic act authorize amendment repeal counter drug notice public procedure finding secretary health_and_human_services category drugs specific drug associated significant risk drugs lack evidence effectiveness food_and_drug_administration fda regulate counter drug advertisements directs commissioner food drugs identify counter drug require amendment repeal report findings congress


Summary: Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits licensure under this Act of a biological product containing specified agents or toxins.Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.Provides for confidentiality of information received pursuant to this Act.Sets forth provisions governing patent infringement actions related to this Act.Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.

pathway act amends public_health_service_act allow person submit application licensure biological product based similarity licensed biological product reference secretary health_and_human_services approve application biological product biosimilar reference product respect condition use reference product approved applicant consents inspection facility subject application sets forth requirements determination secretary biological product interchangeable reference product prohibits biological product evaluated reference product prohibits licensure act biological product containing specified agents toxins prohibits secretary making approval application act effective date reference product licensed provides confidentiality information received pursuant act sets forth provisions governing patent infringement actions related act deems patent infringement submission statement act applicant setting forth reasons making use sale biosimilar product infringe patent patent invalid unenforceable purpose submission obtain approval engage commercial manufacture use sale expiration patent


Summary: Safeguarding America's Pharmaceuticals Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and certain adulterated or misbranded imported drugs.Requires the manufacturer of a prescription drug to provide to each wholesale distributor or dispenser a packing list or comparable document that includes information identifying the drug's proprietary and established names and National Drug Code number.Requires each person engaged in wholesale distribution of a prescription drug to provide information on each prior transaction involving the drug.Requires the Secretary of Health and Human Services (the Secretary) to report to Congress on the feasibility and operational efficiencies of adopting security technologies, including track and trace technology throughout the prescription drug supply chain. Phases in requirements for standardized numerical identifiers that are unique to each unit of a prescription drug.Requires the Secretary to issue regulations to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for such an identifier.Requires the Comptroller General to study the availability and cost of technologies to dispensers to comply with this Act.Requires the Secretary to: (1) award matching grants for drug identification and tracking systems to ensure the security and integrity of the drug supply chain; and (2) issue guidelines for wholesale distributors that prescribe requirements that include mandatory background checks and physical inspection of facilities.Sets forth civil penalties for violations of this Act.Requires the Secretary to study threats to the domestic prescription drug supply chain and make recommendations for improvements.

safeguarding_america pharmaceuticals act amends cosmetic act require secretary treasury destroy imported counterfeit drugs certain adulterated misbranded imported drugs requires manufacturer prescription drug provide wholesale distributor dispenser packing list comparable document includes information identifying drug proprietary established names number requires person engaged wholesale distribution prescription drug provide information prior transaction involving drug requires secretary health_and_human_services secretary report congress feasibility operational efficiencies adopting security technologies including track trace technology prescription drug supply chain phases requirements standardized numerical identifiers unique unit prescription drug requires secretary issue regulations establish effective drug identification tracking system authenticate wholesale distribution history prescription drug subject requirement identifier requires comptroller general study availability cost technologies dispensers comply act requires secretary award matching grants drug identification tracking systems ensure security integrity drug supply chain issue guidelines wholesale distributors prescribe requirements include mandatory background checks physical inspection facilities sets forth civil penalties violations act requires secretary study threats domestic prescription drug supply chain recommendations improvements


Summary: Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug or all clinical trials have been completed; and (4) an application for treatment use has been filed with the Food and Drug Administration (FDA) by a licensed practitioner which sets forth the intended use of the drug, an explanation of the rationale for its use, the treatment protocol, statements of the practitioner's qualifications to use the drug and familiarity with its safety and effectiveness, and a notarized statement of the patient's informed consent. Requires the Secretary of Health and Human Services, within 30 days after an application is filed, to grant permission to the sponsor to furnish such drug to the practitioner under such terms as the sponsor, practitioner, and patient determine to be appropriate, including any agreement to waive liability. Provides for application transmission by telephone or other means of rapid communication and for rapid action on it in an emergency situation.Requires (current law authorizes) the Secretary to approve an application under the Public Health Service Act for a fast track product determined to have an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.

early access treatment act amends cosmetic act require drug approved marketing clinical investigation immediately life threatening disease condition patients comparable satisfactory alternative drug therapy available available treatment use individual patient drug intended treat condition comparable satisfactory alternative available treat stage disease drug investigation controlled clinical trial investigational new drug clinical trials completed application treatment use filed food_and_drug_administration fda licensed practitioner sets forth intended use drug explanation rationale use treatment protocol statements practitioner qualifications use drug safety effectiveness notarized statement patient informed consent requires secretary health_and_human_services days application filed grant permission sponsor furnish drug practitioner terms sponsor practitioner patient determine appropriate including agreement waive liability provides application transmission telephone means rapid communication rapid action emergency situation requires current law authorizes secretary approve application public_health_service_act fast track product determined effect clinical endpoint surrogate endpoint reasonably likely predict clinical benefit


Summary: Responsibility in Drug and Device Advertising Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising in the first three years after approval of a new drug or device. Authorizes the Secretary of Health and Human Services to: (1) waive such prohibition if such advertising would have an affirmative value to public health; and (2) continue such prohibition in subsequent years if the drug or device has significant adverse health effects.Requires any direct-to-consumer advertisement to include a fair balance of the benefits and risks associated with the drug or device.Deems a drug to be misbranded if a direct-to-consumer television advertisement for such drug does not prominently display a statement encouraging individuals to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Requires the Secretary to discontinue the study designed to determine if such a statement is appropriate for television advertisements.Deems a device to be misbranded if a direct-to-consumer television advertisement for such device does not include a statement encouraging individuals to report negative side effects of medical devices to the FDA.Sets forth civil monetary penalties for violations relating to the advertising and promotion of a drug or device. Allows the Secretary to order the distribution of materials to notify the public and the medical community of such a violation and to provide corrective information.Requires the Secretary to conduct an education campaign to increase public awareness of risks that, for some patients, may outweigh the benefits of using a particular drug or device.Authorizes additional appropriations to regulate direct-to-consumer drug and device advertisements.

responsibility drug device advertising act amends cosmetic act prohibit direct consumer advertising years approval new drug device authorizes secretary health_and_human_services waive prohibition advertising affirmative value public health continue prohibition subsequent years drug device significant adverse health effects requires direct consumer advertisement include fair balance benefits risks associated drug device deems drug misbranded direct consumer television advertisement drug prominently display statement encouraging individuals report negative effects prescription drugs food_and_drug_administration fda requires secretary discontinue study designed determine statement appropriate television advertisements deems device misbranded direct consumer television advertisement device include statement encouraging individuals report negative effects medical devices forth civil monetary penalties violations relating advertising promotion drug device allows secretary order distribution materials notify public medical community violation provide corrective information requires secretary conduct education campaign increase public awareness risks patients outweigh benefits particular drug device authorizes additional appropriations regulate direct consumer drug device advertisements


Summary: Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.

access care access act amends federal food drug cosmetic act require secretary health_and_human_services permit investigational drug biological product device available expanded access treatment investigational new drug application treatment investigational device exemption specified compassionate investigational access requirements met gives immunity manufacturer distributor administrator sponsor physician suit liability relating products approved act establishes procedure accelerated approval investigational drug biological product device reasonably likely predict clinical benefit patient suffering life threatening condition requires secretary establish new program expand access investigational treatments individuals life threatening conditions diseases demonstration project medicare program pay drugs biological products devices approved act amends title xviii medicare social security act revise definition medically accepted indication provide coverage covered drug based sponsor organization determination drug medically accepted indication requires secretary consider clinical judgment risks patient disease condition evaluating safety effectiveness drugs biological products devices treat life threatening diseases conditions including evaluation information requires committee evaluating investigational drugs devices biological product applications patient representatives voting members


Summary: Ryan Haight Online Pharmacy Consumer Protection Act of 2008 - Amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of a controlled substance that is a prescription drug over the Internet without a valid prescription. Exempts telemedicine practitioners. Defines "valid prescription" as a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of a patient.Defines "online pharmacy" as a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses a controlled substance by means of the Internet. Excludes from such definition: (1) manufacturers or distributors who do not dispense controlled substances to an unregistered individual or entity; (2) nonpharmacy practitioners; (3) certain hospitals or medical facilities operated by the federal government or by an Indian tribe or tribal organization; (4) mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance; and (5) other persons or entities the exclusion of which the Attorney General and the Secretary of Health and Human Services find to be consistent with effective controls against diversion and with the public health and safety.Imposes registration and reporting requirements on online pharmacies that dispense 100 or more prescriptions or 5,000 or more dosage units of all controlled substances combined in one month. Requires an online pharmacy to: (1) display specified information on its Internet home page, including a statement that it complies with the requirements of this Act, its name, address, and telephone number, the qualifications of its pharmacist-in-charge, and a certification of its registration under this Act; (2) comply with state laws for the licensure of pharmacies in each state in which it operates or sells controlled substances; and (3) notify the Attorney General and applicable state boards of pharmacy 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.Authorizes the Attorney General to issue a special registration under this Act for telemedicine practitioners. Requires practitioners who issue a prescription for a controlled substance under the authorization to conduct telemedicine during a medical emergency to report to the Secretary of Veterans Affairs the authorization of that emergency prescription.Increases criminal penalties involving controlled substances in Schedules III, IV, and V of the Controlled Substances Act. Authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents. Requires the Drug Enforcement Administration (DEA) to report to Congress not later than 180 days after the enactment of this Act and annually for two years after such initial report on: (1) the foreign supply chains and sources of controlled substances offered for sale without a valid prescription on the Internet; (2) DEA efforts and strategy to decrease such foreign supply chains; and (3) DEA efforts to work with domestic and multinational pharmaceutical companies and others in combating the sale of controlled substances over the Internet without a valid prescription.

pharmacy consumer protection act amends controlled substances act prohibit delivery distribution dispensing controlled substance prescription drug internet valid prescription exempts telemedicine practitioners defines valid prescription prescription issued legitimate medical purpose usual course professional practice practitioner conducted person medical evaluation patient defines online pharmacy person entity internet site united_states abroad knowingly intentionally delivers distributes dispenses controlled substance means internet excludes definition manufacturers distributors dispense controlled substances unregistered individual entity practitioners certain hospitals medical facilities operated federal government indian tribe tribal organization mere advertisements attempt facilitate actual transaction involving controlled substance persons entities exclusion attorney general secretary health_and_human_services find consistent effective controls diversion public health safety imposes registration reporting requirements online pharmacies dispense prescriptions dosage units controlled substances combined month requires online pharmacy display specified information internet home page including statement complies requirements act address telephone number qualifications pharmacist charge certification registration act comply state laws licensure pharmacies state operates sells controlled substances notify attorney general applicable state boards pharmacy days prior offering sell deliver distribute dispense controlled substances internet authorizes attorney general issue special registration act telemedicine practitioners requires practitioners issue prescription controlled substance authorization conduct telemedicine medical emergency report secretary veterans_affairs authorization emergency prescription increases criminal penalties involving controlled substances controlled substances act authorizes states apply injunctions obtain damages civil remedies online pharmacies deemed threat state residents requires drug_enforcement_administration dea report congress later days enactment act annually years initial report foreign supply chains sources controlled substances offered sale valid prescription internet dea efforts strategy decrease foreign supply chains dea efforts work domestic multinational pharmaceutical companies combating sale controlled substances internet valid prescription


Summary: Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product.Requires the Secretary of Health and Human Services, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available.Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

strengthening amends cosmetic act apply debarment provisions currently applicable abbreviated new drugs drug products including new drugs animal drugs exported drugs biological products medical devices expands conditions persons partnerships corporations associations subject mandatory debarment preventing persons submitting application approval drug product requires secretary health_and_human_services determining appropriateness period debarment consider debarment affect public health sufficient quantities drug available requires secretary annually report congress implementation debarment provisions


Summary: Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services to initiate debarment not later than one year after a person or individual is convicted of a felony. Requires the Secretary, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

strengthening amends cosmetic act apply debarment provisions currently applicable abbreviated new drugs drug products including new drugs animal drugs exported drugs biological products medical devices expands conditions persons partnerships corporations associations subject mandatory debarment preventing persons submitting application approval drug product requires secretary health_and_human_services initiate debarment later year person individual convicted felony requires secretary determining appropriateness period debarment consider debarment affect public health sufficient quantities drug available requires secretary annually report congress implementation debarment provisions


Summary: Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.

medical device safety act amends cosmetic act provide provisions preempting state local requirements medical devices intended human use shall construed modify affect action damages liability person state law makes act effective included medical device amendments applicable civil action pending filed date enactment act


Summary: Stephanie Tubbs Jones Organ Transplant Authorization Act of 2008 - Amends the Public Health Service Act to increase the maximum amount of funds provided for the establishment and operation of the Organ Procurement and Transplantation Network for any fiscal year. Directs the Secretary of Health and Human Services to request that the Executive Director of the Network report to Congress on the effects of the heart allocation policy change of 2006. Conditions increased funding on submission of such a report.

jones organ transplant authorization act amends public_health_service_act increase maximum funds provided establishment operation fiscal year directs secretary health_and_human_services request executive director network report congress effects heart allocation policy change conditions increased funding submission report


Summary: Savings for the Uninsured on Rx Expenses (SURE) Act of 2008 - Requires the Secretary of Health and Human Services to establish a prescription drug discount card program modeled on the Medicare drug discount card program to provide access to prescription drug discounts for eligible individuals. Defines as "eligible" an individual who: (1) is a U.S. citizen, national, or alien lawfully admitted for permanent residence; (2) is not eligible for outpatient prescription drug coverage; and (3) is not eligible to enroll for prescription drug coverage under part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act. Applies the Medicare drug discount card program requirements related to enrollment and card features, with certain exceptions. Requires a prescription drug card sponsor to disseminate information concerning the use of health savings accounts to cover the costs of prescriptions drugs for which discounts are provided. Directs the Secretary to require that sponsors demonstrate that they have a marketing plan to effectively reach out to eligible individuals. Disallows judicial review of a determination not to endorse a prescription drug discount card program or not to enter into a contract with a sponsor.

savings uninsured expenses sure act requires secretary health_and_human_services establish prescription drug discount card program modeled medicare drug discount card program provide access prescription drug discounts eligible individuals defines eligible individual citizen national alien lawfully admitted permanent residence eligible outpatient prescription drug coverage eligible enroll prescription drug coverage voluntary prescription drug benefit program title xviii medicare social security act applies medicare drug discount card program requirements related enrollment card features certain exceptions requires prescription drug card sponsor disseminate information concerning use health savings accounts cover costs prescriptions drugs discounts provided directs secretary require sponsors demonstrate marketing plan effectively reach eligible individuals disallows judicial review determination endorse prescription drug discount card program enter contract sponsor


Summary: Independent Drug Education and Outreach Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers concerning such drugs and interventions. Requires that grantees receive no support from any entity that manufactures products used to treat the medical conditions discussed.

amends public_health_service_act require secretary health_and_human_services acting director agency healthcare_research quality award grants contracts development production educational materials concerning evidence available relative safety effectiveness cost prescription drugs nonprescription drugs interventions treating selected conditions distributed presented health care providers prescribe drugs patients development implementation program appropriately train deploy health professionals distribute materials educate physicians drug prescribers concerning drugs interventions requires grantees receive support entity manufactures products treat medical conditions discussed


Summary: Medicare Clinical Diagnostic Laboratory Fee Schedule Modernization Act of 2008 - Directs the Secretary of Health and Human Services to: (1) establish a negotiated rulemaking committee to negotiate and develop a proposed rule for a Medicare modernized clinical diagnostic laboratory fee schedule; (2) report to Congress on the fee schedule; and (3) promulgate final regulations to establish it.

fee schedule modernization act directs secretary health_and_human_services establish negotiated rulemaking committee negotiate develop proposed rule medicare modernized clinical diagnostic laboratory fee schedule report congress fee schedule promulgate final regulations establish