Summary: Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user fee provisions.Makes changes to include postmarket safety activities within the process for the review of approved human drug applications or supplements, including developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems. Removes provisions limiting the postmarket safety activities to three years after approval of a new drug.(Sec. 103) Reauthorizes prescription drug new users fees beginning in FY2008. Requires the Secretary to provide a partial refund of an applicant's user fees if the application is withdrawn without a waiver before filing.Sets forth special rules for compounded positron emission tomography drugs, including allowing an applicant for an approved human drug application for a compounded positron emission tomography drug to be subject to one-fifth of the annual prescription drug establishment fee.Establishes the amount of revenue that fees are to generate for FY2008-FY2012. Sets forth provisions regarding adjustments to such fees. Requires the Secretary to: (1) contract with an independent accounting firm to study and make recommendations on the adjustment for changes in review activities; and (2) make appropriate changes to the workload adjustment methodology in setting fees for FY2010-FY2012.Directs the Secretary to consider only the circumstances and assets of the applicant and any affiliate when determining whether to grant a waiver or reduction of fees assessed. Excludes an entity that has a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce from being considered a small business for purposes of application fee waiver rules.(Sec. 104) Requires the Secretary to assess and collect fees for advisory review by the Secretary of direct-to-consumer television advertisement for a prescription drug product. Sets forth procedures for such review.Subjects each person that is assessed an advisory review fee to an operating reserve fee for the first fiscal year in which an advisory review fee is assessed. Establishes the amount of revenue that may be generated from such fees.Requires the Secretary to annually set the fee for advisory review based on the number of direct-to-consumer advertisements that the Secretary will review in the next fiscal year. Sets forth fee limits.Requires the Secretary to establish a Direct-to-Consumer Advisory Review Operating Reserve in the Food and Drug Administration (FDA) salaries and expenses appropriation account to continue such review in the event the fees collected in any subsequent fiscal year do not generate the fee revenue amount established for that fiscal year. Terminates such advisory review if the Secretary fails to receive a certain amount of advisory review fees and operating reserve fees.Terminates provisions for prescription drug user fees on October 1, 2012, except certain reporting requirements.Title II: Drug Safety - (Sec. 200) Enhancing Drug Safety and Innovation Act of 2007- Subtitle A: Risk Evaluation and Mitigation Strategies - (Sec. 201) Amends the FFDCA to require the Secretary to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.Directs the Secretary to: (1) establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis, including procedures to provide for adverse event surveillance by collecting and monitoring health-related electronic data; and (2) develop, support, and participate in complementary approaches to gather and analyze such data and information to the extent the active surveillance infrastructure is not sufficient to gather data and information relevant to priority drug safety questions.Requires the Secretary to establish collaborations with other government, academic, and private entities to provide for the risk identification and analysis of collected data and data that is publicly available or is provided to the Secretary in order to: (1) improve the quality and efficiency of postmarket drug safety risk-benefit analysis; (2) provide the Secretary with routine access to expertise to study advanced drug safety data; and (3) enhance the ability of the Secretary to make timely assessments based on drug safety data.Directs the Secretary to seek recommendations from the Drug Safety and Risk Management Advisory Committee at least biannually on: (1) priority drug safety questions; and (2) mechanisms for answering such questions.Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data; (2) allow for prompt investigation of priority drug safety questions; (3) perform advanced research and analysis on identified drug safety risks; (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for postmarketing data collected; and (5) focus postmarket studies and post-approval clinical trials on cases for which reports and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a drug.Authorizes appropriations for FY2008-FY2012.(Sec. 202) Requires a proposed risk evaluation and mitigation strategy for a new drug to include: (1) labeling for the drug for use by health care providers; and (2) a timetable for submission of assessments of the strategy. Sets forth as additional elements that a risk evaluation and mitigation strategy may include: (1) post-approval studies; (2) advertisement pre-review requirements; (3) specific disclosures in advertisements; and (4) additional elements to assure safe use. Allows an application for approval of a new drug or a license for a biological product to include a proposed risk evaluation and mitigation strategy if there is a signal of a serious risk with a drug. Authorizes the Secretary to require that the applicant submit a proposed risk evaluation and mitigation strategy if the Secretary determines that, based on such a signal, a risk evaluation and mitigation strategy is necessary to assess such signal or mitigate such risk. Sets forth a time frame for submission of such a strategy when ordered by the Secretary. Allows (or requires, if ordered by the Secretary) an applicant to submit assessments or propose modifications of such a strategy. Establishes a Drug Safety Oversight Board to: (1) oversee disputes related to a proposed risk evaluation and mitigation strategy, except for disputes during initial approval of a drug; and (2) provide oversight and advice to the Secretary on the management of important drug safety issues.Sets forth civil penalties for knowingly failing in an application to comply with a requirement of an approved risk evaluation and mitigation strategy.(Sec. 203) Deems a drug to be misbranded if it is a drug subject to an approved risk evaluation and mitigation strategy and the applicant fails to: (1) make a labeling change required by such strategy; or (2) comply with the advertising requirements of such strategy. Sets forth civil penalties for knowingly failing to comply with a requirement of such strategy.(Sec. 204) Amends the Public Health Service Act to allow an applicant for a license for a biological product to submit to the Secretary a proposed risk evaluation and mitigation strategy.(Sec. 205) Authorizes the Secretary to withdraw or suspend approval of a new drug application without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug.(Sec. 206) Provides that a drug that is the subject of an abbreviated new drug application (generic) shall be subject to only the following elements of an approved risk evaluation and mitigation strategy if required for the applicable listed drug: (1) labeling, as required for the applicable listed drug; (2) a Medication Guide or patient package insert; (3) pre-review of advertising; (4) specific disclosures in advertising; and (5) elements to assure safe use as necessary. (Sec. 207) Includes within the process for review of human drug application requirements that the Secretary conduct postmarket safety activities that include reviewing, implementing, and ensuring compliance with risk evaluation and mitigation strategies.Sets forth fee revenue amounts for FY2008-FY2012. Requires the Secretary to submit to the relevant congressional committees a strategic plan on information technology that includes: (1) an assessment of the information technology infrastructure; (2) an assessment of the extent to which the current FDA information technology assets are sufficient to meet needs; and (3) a plan and assessment of resources needed for enhancing such assets.(Sec. 208) Requires the holder of an approved new drug application or a biological product license to promptly notify the Secretary of new safety information that should be included in the labeling of the drug. Requires the Secretary to promptly notify the holder if the Secretary becomes aware of new safety information that should be included. Sets forth an accelerated labeling review process to resolve disagreements between the Secretary and a holder about the need for, or content of, safety labeling changes. Requires the Drug Safety Oversight Board to resolve such disputes, as necessary.(Sec. 209) Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to such data by developing and maintaining an Internet website that: (1) provides comprehensive 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. 210) 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. 211) Requires the Secretary to establish the Advisory Committee on Risk Communication to advise the Commissioner on which methods to use to effectively communicate risk associated with the products regulated by the FDA.Requires the Secretary to partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.(Sec. 212) 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. Allows the advisory committee review to occur within one year after approval if: (1) the clinical trial that formed the primary basis of the safety and efficacy determination was halted by a drug safety monitoring board of an Institutional Review Board before its scheduled completion due to early unanticipated therapeutic results; or (2) the Secretary determines that it would be beneficial to the public health.(Sec. 213) Requires the Secretary to issue a report responding to the Institute of Medicine report on drug safety.(Sec. 214) Deems drugs approved before the effective date of this Act to have an approved risk evaluation and mitigation strategy if there are restrictions on distribution or use of such a drug. Requires the Secretary to notify applicants of the date by which an assessment of an approved strategy must be submitted, which date shall be no earlier than six months after the applicant is notified, except with respect to the drug Mifeprex (mifepristone) for which such assessment must be submitted six months after the applicant is notified.Subtitle B: Reagan-Udall Foundation for the Food and Drug Administration - (Sec. 221) 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 devices, biologics, and drugs and the safety of food, food ingredients, and cosmetics; (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. Requires the Foundation's Board of Directors to appoint an Executive Director. Directs the Commissioner to receive and assess reports submitted by the Executive Director. Sets forth reporting requirements.(Sec. 222) 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 and ensure that there is no duplication of research efforts supported by the Foundation; (3) develop and advocate for a budget to support intramural research; (4) develop a peer review process by which intramural research can be evaluated; and (5) identify and solicit intramural research proposals from across the FDA through an advisory board composed of FDA employees.Subtitle C: Clinical Trials - (Sec. 231) 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. Requires the Secretary to expand the data bank to require the submission of specified information for applicable drug clinical trials and applicable device clinical trials. 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 involved or device involved is cleared or approved. Requires the Director to conduct a study to determine the best, validated methods of making the results of clinical trials publicly available after the approval of drugs.Prohibits the submission of promotional or false or misleading clinical trial information. Sets forth civil penalties for violations.Subtitle D: Conflicts of Interest - (Sec. 241) Requires the Secretary to recruit individuals to serve as advisory committee members. Requires the Secretary to review the individual's financial disclosure report and expertise when considering a term appointment to an advisory committee. Sets forth provisions governing the granting of waivers and financial interests of advisory committee members. Subtitle E: Other Drug Safety Provisions - (Sec. 251) Directs the Commissioner to publish and update, quarterly, a complete list of all authorized generic drugs on the FDA's website.(Sec. 252) Requires the Secretary to require that state-legalized medical marijuana be subject to the full regulatory requirements of the FDA.Subtitle F: Antibiotic Access and Innovation - (Sec. 261) Makes certain antibiotic drugs eligible for market exclusivity if an application for marketing is submitted after enactment of this Act for an antibiotic drug that: (1) was approved by the Secretary before November 21, 1997; or (2) was the subject of one or more applications received by the Secretary before November 21, 1997, none of which was approved. (Sec. 262) Requires the Commissioner of Food and Drugs to convene a public meeting regarding which serious and life-threatening infectious diseases potentially qualify for available grants and contracts or other incentives for orphan drug development.(Sec. 263) 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. 264) 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. 265) 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 III: Medical Devices - Subtitle A: Device User Fees - (Sec. 301) Medical Device User Fee Amendments of 2007 - (Sec. 302) Establishes the purpose of collecting medical device fees, including that such fees be dedicated towards expediting the process for the review of device applications and assuring the safety and effectiveness of devices.Sets forth reporting requirements, including requiring the Secretary to report to the relevant congressional committees on the FDA's progress in achieving specified goals.Terminates medical device user fee provisions on October 1, 2012, except certain reporting requirements.(Sec. 303) Makes changes to medical device fees, including establishing fees for: (1) a 30-day notice for a supplement to an approved premarket application or premarket report that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and effectiveness of the device; (2) a request for classification information; (3) periodic reporting concerning a class III device; and (4) each initial or annual registration for establishments subject to a registration fee.Establishes medical device fee amounts.Makes changes to provisions related to qualifications for fee waivers for small businesses.Authorizes appropriations.(Sec. 305) Makes this subtitle effective on October 1, 2007.Subtitle B: Amendments Regarding Regulation of Medical Devices - (Sec. 311) Requires a person accredited to conduct inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices to notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems for any device establishment that such person inspects within 30 days after such action. Allows an accredited person to conduct audits to establish conformance with the quality systems. Sets forth conditions that a device establishment must meet to be eligible for inspections by accredited persons. Deems a device establishment to have clearance to participate in the program and to use an accredited person for inspections unless the Secretary denies such clearance or requests certain compliance data or information concerning the relationship between the owner of the establishment and the accredited person. Sets forth conditions under which the Secretary may deny clearance.(Sec. 312) Extends the authority of accredited persons to review pre-market reports for devices and make recommendations to the Secretary regarding the initial classification of devices.(Sec. 313) Requires every person who owns or operates any establishment in any state engaged in the manufacture, preparation, propagation, compounding, or processing of a device to register with the Secretary. Requires any such establishment within a foreign country to register electronically with the Secretary.(Sec. 314) Requires a registered person to report to the Secretary with regard to devices once each year.(Sec. 315) Requires electronic registration for device establishments, unless the Secretary grants a waiver.Title IV: Pediatric Medical Products - Subtitle A: Best Pharmaceuticals for Children - Best Pharmaceuticals for Children Amendments of 2007 - (Sec. 402) Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that the studies are completed using appropriate formulations for each age group for which the study is requested; (2) require that appropriate labeling changes are made as determined appropriate by the Secretary within a time frame requested by the Secretary; and (3) prohibit the Secretary from extending market exclusivity if the determination of eligibility for such market exclusivity is made less than nine months prior to its expiration.Requires an applicant or holder who does not agree with a request to conduct pediatric studies on the grounds that it is not possible to develop the appropriate pediatric formulation to submit to the Secretary the reasons such pediatric formulation 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 that are available prior to submission of reports on such studies.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 formulation is not introduced onto the market within one year after the Secretary's determination regarding market exclusivity; and (2) create an internal review committee to review all written requests issued and all reports submitted. Requires the committee to be responsible for tracking and making available to the public: (1) the number of pediatric studies conducted; (2) the specific drugs and uses studied; (3) the types of studies conducted, the number of pediatric patients studied, and the number of centers and countries involved; (4) the number of pediatric formulations developed and the number not developed and the reasons formulations were not developed; (5) the labeling changes made as a result of studies; (6) an annual summary of labeling changes made as a result of studies conducted for distribution; and (7) information regarding reports submitted after enactment of this Act.Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.Requires the Secretary to: (1) order the labeling of a drug to include information about the result of a pediatric study whether it does or does not demonstrate that the drug is safe and effective, including whether such study results are inconclusive; (2) ensure that all adverse event reports that have been received are referred to the Office of Pediatric Therapeutics for review.(Sec. 403) Reauthorizes the Secretary, acting through the Director of NIH, to: (1) develop, publish, and revise every three years a priority list of needs in pediatric therapeutics; and (2) report to Congress on the feasibility of establishing a compilation of information on pediatric drug use. Requires the Director to submit proposed pediatric study requests for consideration by the Commissioner.(Sec. 404) Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the written requests made for pediatric studies and the studies conducted.(Sec. 405) 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.(Sec. 406) 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 pediatric studies of drugs for which the Secretary determines that there is a continuing need for information relating to the use of the drug in a pediatric population.(Sec, 407) Requires the advisory committee on pediatric therapeutics to continue to operate for five years after enactment of this Act.(Sec. 408) 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.(Sec. 409) 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 the final rule is issued before such date. Subtitle B: Pediatric Research Improvement - Pediatric Research Improvement Act - (Sec. 412) Requires an applicant seeking a waiver from requirements to submit pediatric assessments for new drugs and biological products to submit to the Secretary documentation detailing why a pediatric formulation cannot be developed.Requires an applicant to annually submit to the Secretary: (1) information detailing the progress made in conducting pediatric studies; or (2) if no progress has been made, evidence and documentation that such studies will be conducted with due diligence and at the earliest possible time. Requires such information to promptly be made publicly available.(Sec. 413) Requires an applicant seeking a waiver from a requirement to submit a pediatric assessment for an already marketed drug or biological product to submit to the Secretary documentation detailing why a pediatric formula cannot be developed. Requires the the applicant's submission to promptly be made available to the public if such a waiver is granted.(Sec. 414) Requires the Secretary to create an internal committee to review pediatric assessment requests, pediatric assessments conducted, and deferral and waiver requests from such requirements. Makes the committee responsible for tracking and making public in an easily accessible manner information related to such pediatric assessments, including: (1) the number of assessments conducted and the drugs and drug uses assessed; (2) the number of pediatric formulations developed and the number not developed and the reasons formulations were not developed; and (3) the labeling changes made as a result of assessments.Deems any supplement to a new drug applicant or license for a biological product proposing a labeling change as a result of any pediatric assessments to be a priority supplement.Provides for referral to the Pediatric Advisory Committee for disputes on labeling changes. Requires the Secretary to: (1) order the labeling of a product to include information about the results of the assessment and a statement of the Secretary's determination that a pediatric assessment does or does not demonstrate that the drug is safe and effective; and (2) make publicly available the medical, statistical, and clinical pharmacology reviews of such pediatric assessments; and (3) ensure that all adverse event reports that have been received for the drug are referred to the Office of Pediatric Therapeutics for review.(Sec 415) Considers a drug to represent a meaningful therapeutic benefit over existing therapies if the Secretary determines (currently, estimates) that the drug or biological product if approved could (currently, would) represent a significant improvement in the treatment, diagnosis, or prevention of a disease.(Sec. 416) Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies of new drugs or biological products conducted pursuant to the FFDCA since 1997.Requires the Comptroller General to submit to Congress a report that addresses the effectiveness of such studies in ensuring that medicines used by children are tested and properly labeled.Subtitle C: Pediatric Medical Devices - Pediatric Medical Device Safety and Improvement Act of 2007 - (Sec. 422) 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. 423) Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device, if: (1) the device is intended for the treatment or diagnosis of 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.Requires the Secretary to refer any adverse event report related to a device to the Office of Pediatric Therapeutics for review.Directs the Comptroller General to report on the impact of allowing persons granted a humanitarian device exemption to profit from such device.(Sec. 424) Requires the Secretary, acting through the Director of NIH, to designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.(Sec. 425) Requires the Secretary to award grants for demonstration projects to promote pediatric device development.(Sec. 426) Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Requires the Office to report to the relevant congressional committees a plan for expanding pediatric medical device research and development. Expands the duties of the advisory committee on pediatric therapeutics to include providing advice and recommendations on matters relating to medical devices.(Sec. 427) 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) a postmarket surveillance as a condition of approval of an application or a product development protocol or as a condition to clearance of a premarket notification for such pediatric devices; and (3) a prospective surveillance period of more than 36 months for such pediatric devices as necessary to assess the impact of the device on growth and development or the effects of growth, development, activity level, or other factors on the safety of the device.Title V: Other Provisions - (Sec. 501) Amends the FFDCA to require the Secretary, through the Commissioner of Food and Drugs, 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. 504) Expresses the sense of the Senate that legislation should be enacted to provide the FDA with the authority and flexibility to approve biopharmaceuticals subject to an abbreviated approval pathway.(Sec. 505) Requires the Secretary to: (1) award a transferable, priority review voucher to the sponsor of a tropical disease product upon approval by the Secretary of such product; and (2) establish a priority review user fee program.(Sec. 506) Prohibits the Secretary from delaying approval of a new drug application while a petition is reviewed or considered, unless such a delay is necessary to protect the public health. Requires the Secretary to take final agency action on a petition not later than 180 days after submission, unless such a delay is necessary. Requires petitions to be signed and to contain specified verifications.Sets forth reporting requirements.Requires the Office of the Inspector General of the Department of Health and Human Services (HHS) to evaluate evidence of FDA compliance with the requirement that the consideration by the Secretary of petitions that do not raise public health concerns remain separate and apart from the review and approval of a new drug application.(Sec. 507) Requires the Commissioner to annually submit to Congress and the public on the FDA's Internet website a report concerning the results of the FDA's pesticide residue monitoring program.(Sec. 508) Amends the Head Start Act to require a Head Start agency to obtain written parental consent before administration of any nonemergency intrusive physical examination of a child in connection with participation in a Head Start program.(Sec. 509) Requires the FDA to report on the question of whether substances used to preserve the appearance of fresh meat may create any health risks or mislead consumers.(Sec. 510) 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. (Sec. 511) Expresses the sense of the Senate that the FDA should enter into a contract with the Institute of Medicine for a study concerning measures that may be taken to improve the likelihood that FDA-approved drugs that are safe and effective in treating children with orphan diseases (rare genetic diseases) are made available and affordable for pediatric indications.(Sec. 512) Requires the Secretary, after the close of a fiscal year in which color certification fees are collected, to submit to Congress: (1) a performance report on the number of batches of color additives approved, the average turn around time for approval, and quantifiable goals for improving laboratory efficiencies; and (2) a financial report for the color certification program.(Sec. 513) Prohibits any food product from being imported into the United States that is the product of a registered foreign food facility that refuses to permit U.S. inspectors, upon request, to inspect such facility or that unduly delays access to U.S. inspectors.(Sec. 514) Provides that the certification requirement before implementation of the prescription drug importation provisions under this Act shall not apply to requirements for counterfeit-resistant technologies.(Sec. 515) 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. 516) Expresses the sense of the Senate that the U.S. Trade Representative should: (1) use all available tools to address violations and other concerns with intellectual property; and (2) develop and submit to Congress a strategic plan to address the problem of countries infringing upon American pharmaceutical intellectual property rights and engaging in price manipulation.(Sec. 517) Requires the Commissioner of Food and Drugs to produce a report on any environmental risks associated with genetically engineered seafood products.(Sec. 518) Requires the Secretary to submit to the relevant congressional committees a report on the differences between taxonomies of certain species of lobster.(Sec. 519) Establishes civil penalties for dissemination of false or misleading direct-to-consumer advertisements for a prescription drug.(Sec. 520) Requires the Secretary, acting through the Commissioner, 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) modifying the warning label required on tanning beds would communicate such risks more effectively; and (3) there is no warning that would be capable of adequately communicating such risks. Requires the Secretary, in making such determinations, to: (1) conduct appropriate consumer testing using the best available methods for determining consumer understanding of label warnings; and (2) hold public hearings and solicit comments from the public.Title VI: Food Safety - (Sec. 602) Requires the Secretary to establish: (1) processing and ingredient standards with respect to pet food, animal waste, and ingredient definitions; and (2) update standards pet food labeling that includes 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. 603) Requires the Secretary, during an ongoing recall of human or pet food, 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 products on the FDA's website in a consolidated, searchable form that is easily accessed and understood by the public.(Sec. 604) Requires the Secretary to work with states in undertaking activities that assist in improving the safety of fresh and processed produce.(Sec. 605) Requires the Secretary to establish an Adulterated Food Registry to which instances of reportable adulterated food may be submitted by the FDA. Requires the Secretary to issue an alert if the Registry shows that a food: (1) has been associated with repeated and separate outbreaks of illness or has been repeatedly determined to be adulterated; or (2) is a reportable adulterated food. Allows such an alert to apply to a particular food or to food from a particular producer, manufacturer, shipper, growing area, or country.Requires a responsible party or importer who determines that an article of food it produced, processed, manufactured, distributed, or otherwise handled is a reportable adulterated food to provide notification to other parties linked in the supply chain and to submit a report to the FDA.Requires the Secretary to immediately notify the Secretary of Homeland Security if the Secretary suspects such food may have been deliberately adulterated.(Sec. 606) Expresses the sense of the Senate 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) the Senate should work to develop a comprehensive response to the issue of food safety.(Sec. 607) Sets forth reporting requirements with respect to food products regulated by the FDA.(Sec. 609) Authorizes appropriations.Title VII: Domestic Pet Turtle Market Access - Domestic Pet Turtle Market Access Act of 2007 - (Sec. 703) Prohibits the Food and Drug Administration (FDA) from restricting the sale by a turtle farmer, wholesaler, or other commercial retail seller of a turtle that is less than 10.2 centimeters in diameter as a pet if: (1) the state or territory in which such farmer is located has developed a regulatory process by which pet turtle farmers are required to have a state license; (2) such state or territory requires certification of sanitization that requires each turtle to be sanitized or treated for diseases and is dependent upon using proven non-antibiotic methods to make the turtle salmonella-free; and (3) the turtle farmer or commercial retail seller makes certain disclosures to a buyer. Sets forth required disclosures, which include: (1) information regarding the possibility that salmonella can re-colonize in turtles, the dangers that could result if the turtle is not properly handled and safely maintained, the proper handling of the turtle, and the proven methods of treatment that keep the turtle safe from salmonella; (2) a detailed explanation of how to properly treat the turtle to keep it safe from salmonella and how the buyer can continue to purchase the tools, treatments, or any other required item to continually treat the turtle; and (3) a statement that buyers of pet turtles should not abandon turtles, but should instead return them to a commercial retail pet seller or other organization that would accept turtles no longer wanted as pets.(Sec. 704) Authorizes the Commissioner of Food and Drugs to restrict the sale of a turtle only if the Secretary determines that the actual implementation of state health protections are insufficient to protect consumers against infectious diseases acquired from such turtle at the time of sale.Title VIII: Importation of Prescription Drugs - Pharmaceutical Market Access and Drug Safety Act of 2007 - (Sec. 804) Amends the FFDCA to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States.Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use. Defines "qualifying drug" as a drug for which there is a corresponding U.S. label drug.Includes among registration conditions for importers and exporters: (1) the drug to be imported or exported was manufactured in an approved facility and manufactured for sale in the United States or a permitted country; (2) a chain of custody exists for such drug; (3) the exporter or importer allows onsite inspections by the Secretary; (4) there is proper labeling of the shipment; (5) importers provide prior notice of all shipments; and (6) importers and exporters pay a registration fee and an inspection fee.Requires the Secretary to inspect places of business, verify chain of custody, review records, monitor shipment labels, inspect facilities, and check for compliance with registration conditions.Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences, labeling requirements, and bioequivalence.Establishes conditions for individual importation of a qualifying drug, including requiring a valid prescription and a quantity not exceeding a 90-day supply.Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person engaged in the importation of a qualifying drug. Allows states to bring actions for violations.States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.Gives priority in the registration of exporters to significant Canadian exporters. Allows the Secretary to limit the number of registered exporters and importers.Requires the Secretary to educate consumers regarding prescription drug importation.(Sec. 805) Requires the Secretary of Homeland Security to deliver violative shipments to the Secretary. Requires the Secretary to destroy such shipments under certain circumstances.(Sec. 806) Requires the Secretary to establish alternative requirements to identify the chain of custody of a drug from the manufacturer throughout the wholesale distribution to a pharmacist who intends to sell the drug at retail if the Secretary determines that such requirements: (1) will identify such chain of custody or the identity of the discrete package from which the drug is dispensed with equal or greater certainty than current requirements; and (2) are economically and technically feasible.Directs the Secretary to require the use of standardized anti-counterfeiting and track-and-track technologies on prescription drugs at the case and pallet level. Sets forth additional counterfeiting technologies to be incorporated into prescription drug packaging.(Sec. 807) Prohibits any person from dispensing a prescription drug pursuant to a sale if: (1) any part of the sales transaction for the drug is conducted through an Internet site; (2) the person dispenses the drug to the purchaser by mailing or shipping the drug to the purchaser; and (3) such site fails to meet specified requirements regarding inclusion of a page (and links thereto) providing the identities and licensing information of the seller, pharmacists, or medical consultants.Prohibits a person from selling or dispensing a prescription drug if: (1) the purchaser communicated with the person through the Internet; (2) the purchaser did not have a valid prescription when the communication began; (3) the person provided for the involvement of a practitioner; (4) the practitioner issued a prescription for the drug that was purchased; (5) the person knew that no qualifying medical relationship existed (defines "qualifying medical relationship" as requiring an in-person medical evaluation); and (6) the person received payment.Allows states to bring civil actions against a person for violations of this Act.Prevents Internet providers from being held liable for dispensing or selling prescription drugs on account of another person's activities. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under the FFDCA.Requires the Secretary to award a grant or contract to the National Clearinghouse on Internet Prescribing to identify and report Internet sites that violate federal or state laws concerning the dispensing of drugs.(Sec. 808) Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.Requires the Board of Governors of the Federal Reserve System to promulgate regulations requiring designated payment systems to establish policies and procedures that are reasonably designed to prevent the introduction of a restricted transaction into a payment system.(Sec. 809) Amends the Controlled Substances Import and Export Act to allow a U.S. resident entering the United States with a controlled substance for which the individual does not have a valid prescription to import not more than ten dosage units combined of all such controlled substances.(Sec. 811) Directs that this title only becomes effective if the Secretary certifies to Congress that its implementation will: (1) pose no additional risk to the public's health and safety; and (2) result in a significant reduction in the cost of covered products to the American consumer.

food_and_drug_administration revitalization act title prescription drug user fees sec prescription drug user fee amendments sec amends cosmetic act ffdca set forth purpose authorized prescription drug fees dedicated expediting drug development process process review human drug applications postmarket drug safety sets forth reporting requirements including requiring secretary secretary present congress recommendations developed achieving certain goals review process human drug applications reauthorization user fee provisions makes changes include postmarket safety activities process review approved human drug applications supplements including developing improved adverse event data collection systems improved analytical tools assess potential safety problems removes provisions limiting postmarket safety activities years approval new reauthorizes prescription drug new users fees beginning fy2008 requires secretary provide partial refund applicant user fees application withdrawn waiver filing sets forth special rules compounded positron emission tomography drugs including allowing applicant approved human drug application compounded positron emission tomography drug subject fifth annual prescription drug establishment fee establishes revenue fees generate fy2008 fy2012 sets forth provisions adjustments fees requires secretary contract independent accounting firm study recommendations adjustment changes review activities appropriate changes workload adjustment methodology setting fees fy2010 secretary consider circumstances assets applicant affiliate determining grant waiver reduction fees assessed excludes entity drug product approved human drug application introduced delivered introduction interstate commerce considered small business purposes application fee waiver requires secretary assess collect fees advisory review secretary direct consumer television advertisement prescription drug product sets forth procedures review subjects person assessed advisory review fee operating reserve fee fiscal year advisory review fee assessed establishes revenue generated fees requires secretary annually set fee advisory review based number direct consumer advertisements secretary review fiscal year sets forth fee limits requires secretary establish direct consumer advisory review operating reserve food_and_drug_administration fda salaries expenses appropriation account continue review event fees collected subsequent fiscal year generate fee revenue established fiscal year terminates advisory review secretary fails receive certain advisory review fees operating reserve fees terminates provisions prescription drug user fees october certain reporting requirements title drug safety sec innovation act subtitle risk evaluation mitigation strategies sec amends ffdca require secretary establish minimum standards collection transmission data elements electronic health data systems validated integrated postmarket risk identification analysis system integrate analyze safety data multiple sources directs secretary establish maintain active surveillance infrastructure collect report data pharmaceutical postmarket risk identification analysis including procedures provide adverse event surveillance collecting monitoring health related electronic data develop support participate complementary approaches gather analyze data information extent active surveillance infrastructure sufficient gather data information relevant priority drug safety questions requires secretary establish collaborations government academic private entities provide risk identification analysis collected data data publicly available provided secretary order improve quality efficiency postmarket drug safety risk benefit analysis provide secretary routine access expertise study advanced drug safety data enhance ability secretary timely assessments based drug safety data directs secretary seek recommendations biannually priority drug safety questions mechanisms answering questions requires secretary establish implement procedures secretary routinely collaborate qualified entity clean classify aggregate data allow prompt investigation priority drug safety questions perform advanced research analysis identified drug safety risks convene expert advisory committee oversee establishment standards ethical scientific uses data collected focus postmarket studies post approval clinical trials cases reports safety signal detection sufficient resolve elevated risk adverse event associated use drug authorizes appropriations fy2008 requires proposed risk evaluation mitigation strategy new drug include labeling drug use health care providers timetable submission assessments strategy sets forth additional elements risk evaluation mitigation strategy include post approval studies advertisement pre review requirements specific disclosures advertisements additional elements assure safe use allows application approval new drug license biological product include proposed risk evaluation mitigation strategy signal risk drug authorizes secretary require applicant submit proposed risk evaluation mitigation strategy secretary determines based signal risk evaluation mitigation strategy necessary assess signal mitigate risk sets forth time frame submission strategy ordered secretary allows requires ordered secretary applicant submit assessments propose modifications strategy oversee disputes related proposed risk evaluation mitigation strategy disputes initial approval drug provide oversight advice secretary management important drug safety issues sets forth civil penalties knowingly failing application comply requirement approved risk evaluation mitigation deems drug misbranded drug subject approved risk evaluation mitigation strategy applicant fails labeling change required strategy comply advertising requirements strategy sets forth civil penalties knowingly failing comply requirement amends public_health_service_act allow applicant license biological product submit secretary proposed risk evaluation mitigation authorizes secretary withdraw suspend approval new drug application ordering applicant submit assessment approved risk evaluation mitigation strategy provides drug subject abbreviated new drug application generic shall subject following elements approved risk evaluation mitigation strategy required applicable listed drug labeling required applicable listed drug patient package insert pre review advertising specific disclosures advertising elements assure safe use necessary sec includes process review human drug application requirements secretary conduct postmarket safety activities include reviewing implementing ensuring compliance risk evaluation mitigation strategies sets forth fee revenue amounts fy2008 fy2012 requires secretary submit relevant congressional committees strategic plan information technology includes assessment information technology infrastructure assessment extent current fda information technology assets sufficient meet needs plan assessment resources needed enhancing requires holder approved new drug application biological product license promptly notify secretary new safety information included labeling drug requires secretary promptly notify holder secretary aware new safety information included sets forth accelerated labeling review process resolve secretary holder need content safety labeling changes requires drug safety oversight board resolve disputes requires secretary improve transparency pharmaceutical data allow patients health care providers better access data developing maintaining internet website provides comprehensive 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 use effectively communicate risk associated products regulated secretary partner professional medical societies medical schools academic medical centers stakeholders develop robust multi systems communication health care providers emerging postmarket drug requires secretary refer drug active ingredient approved application fda advisory committee review prior approval allows advisory committee review occur year approval clinical trial formed primary basis safety efficacy determination drug safety monitoring board scheduled completion early unanticipated therapeutic results secretary determines beneficial public requires secretary issue report responding institute_of_medicine report drug deems drugs approved effective date act approved risk evaluation mitigation strategy restrictions distribution use drug requires secretary notify applicants date assessment approved strategy submitted date shall earlier months applicant notified respect drug assessment submitted months applicant notified subtitle food_and_drug_administration 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 devices biologics drugs safety food food ingredients cosmetics 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 requires foundation board_of_directors appoint executive director directs commissioner receive assess reports submitted executive director sets forth reporting 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 ensure duplication research efforts supported foundation develop advocate budget support intramural research develop peer review process intramural research evaluated identify solicit intramural research proposals fda advisory board composed fda employees subtitle clinical trials 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 requires secretary expand data bank require submission specified information applicable drug clinical trials applicable device clinical trials requires secretary ensure data bank includes links results information clinical trials form primary basis efficacy claim conducted drug involved device involved cleared approved requires director conduct study determine best validated methods making results clinical trials publicly available approval drugs prohibits submission promotional false misleading clinical trial information sets forth civil penalties violations subtitle conflicts interest sec requires secretary recruit individuals serve advisory committee members requires secretary review individual financial disclosure report expertise considering term appointment advisory committee sets forth provisions governing granting waivers financial interests advisory committee members subtitle sec directs commissioner publish update quarterly complete list authorized generic drugs fda requires secretary require state medical marijuana subject regulatory requirements antibiotic access innovation sec makes certain antibiotic drugs eligible market exclusivity application marketing submitted enactment act antibiotic drug approved secretary november subject applications received secretary november approved sec requires commissioner food drugs convene public meeting life threatening infectious diseases potentially qualify available grants contracts incentives orphan drug requires secretary commissioner identify periodically update clinically susceptible concentrations specific values characterize bacteria clinically susceptible intermediate resistant drug 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 title iii medical devices subtitle device user fees sec medical device user fee amendments sec establishes purpose collecting medical device fees including fees dedicated expediting process review device applications assuring safety effectiveness devices sets forth reporting requirements including requiring secretary report relevant congressional committees fda progress achieving specified goals terminates medical device user fee provisions october certain reporting makes changes medical device fees including establishing fees day notice supplement approved premarket application premarket report limited request modifications manufacturing procedures methods affecting safety effectiveness device request classification information periodic reporting concerning class iii device initial annual registration establishments subject registration fee establishes medical device fee amounts makes changes provisions related qualifications fee waivers small businesses authorizes makes subtitle effective october amendments regulation medical devices sec requires person accredited conduct inspections establishments manufacture prepare propagate compound process class class iii devices notify secretary withdrawal suspension restriction expiration certificate conformance quality systems device establishment person days action allows accredited person conduct audits establish conformance quality systems sets forth conditions device establishment meet eligible inspections accredited persons deems device establishment clearance participate program use accredited person inspections secretary denies clearance requests certain compliance data information concerning relationship owner establishment accredited person sets forth conditions secretary deny extends authority accredited persons review pre market reports devices recommendations secretary initial classification requires person owns operates establishment state engaged manufacture preparation propagation compounding processing device register secretary requires establishment foreign country register electronically requires registered person report secretary regard devices requires electronic registration device establishments secretary grants waiver title pediatric medical products subtitle best pharmaceuticals sec amends cosmetic act changes provisions regard market exclusivity pediatric drug studies new drugs approved drugs including require studies completed appropriate formulations age group study requested require appropriate labeling changes determined appropriate secretary time frame requested secretary prohibit secretary extending market exclusivity determination eligibility market exclusivity months prior expiration requires applicant holder agree request conduct pediatric studies grounds possible develop appropriate pediatric formulation submit secretary reasons pediatric formulation developed requires applicant holder agrees request provide secretary postmarket adverse event reports drug available prior submission reports studies directs secretary publish notice identifying drug pediatric formulation developed studied found safe effective pediatric population formulation introduced market year secretary determination market exclusivity create internal review committee review written requests issued reports submitted requires committee responsible tracking making available public number pediatric studies conducted specific drugs uses studied types studies conducted number pediatric patients studied number centers countries involved number pediatric formulations developed number developed reasons formulations developed labeling changes result studies annual summary labeling changes result studies conducted distribution information reports submitted enactment act reduces market exclusivity pediatric studies months months drugs combined annual gross sales exceed billion requires secretary order labeling drug include information result pediatric study demonstrate drug safe effective including study results ensure adverse event reports received referred office_of_pediatric_therapeutics reauthorizes secretary acting director nih develop publish revise years priority list needs pediatric report congress feasibility establishing compilation information pediatric drug use requires director submit proposed pediatric study requests consideration requires comptroller general submit report congress addresses effectiveness providing market exclusivity pediatric studies ensuring medicines children tested properly labeled requires secretary contract institute_of_medicine study report congress written requests pediatric studies studies requires director include health professionals intend build careers pediatric pharmacological research institute career development activities includes pediatric pharmacological research pediatric research loan repayment authorizes foundation national_institutes_of_health solicit accept gifts grants donations establish accounts invest expend funds support pediatric studies drugs secretary determines continuing need information relating use drug pediatric requires advisory committee pediatric continue operate years enactment requires provide recommendations internal review committee reviews pediatric research requests respect treatment pediatric cancer continue operate years enactment act sets forth reporting directs proposed rule issued commissioner entitled toll free number reporting adverse events labeling human drug products effect january final rule issued date subtitle pediatric research improvement pediatric research improvement act sec requires applicant seeking waiver requirements submit pediatric assessments new drugs biological products submit secretary documentation detailing pediatric formulation developed requires applicant annually submit secretary information detailing progress conducting pediatric studies progress evidence documentation studies conducted diligence earliest possible time requires information promptly publicly requires applicant seeking waiver requirement submit pediatric assessment marketed drug biological product submit secretary documentation detailing pediatric formula developed requires applicant submission promptly available public waiver requires secretary create internal committee review pediatric assessment requests pediatric assessments conducted deferral waiver requests requirements makes committee responsible tracking making public easily accessible manner information related pediatric assessments including number assessments conducted drugs drug uses assessed number pediatric formulations developed number developed reasons formulations developed labeling changes result assessments deems supplement new drug applicant license biological product proposing labeling change result pediatric assessments priority supplement provides referral pediatric_advisory_committee disputes labeling changes requires secretary order labeling product include information results assessment statement secretary determination pediatric assessment demonstrate drug safe effective publicly available medical statistical clinical pharmacology reviews pediatric assessments ensure adverse event reports received drug referred office_of_pediatric_therapeutics considers drug represent meaningful therapeutic benefit existing therapies secretary determines currently estimates drug biological product approved currently represent significant improvement treatment diagnosis prevention requires secretary contract institute_of_medicine study report congress pediatric studies new drugs biological products conducted pursuant ffdca comptroller general submit congress report addresses effectiveness studies ensuring medicines children tested properly labeled subtitle 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 medical device distributed pursuant humanitarian device exemption prohibition device sold exceeds cost device device intended treatment diagnosis 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 directs comptroller general report impact allowing persons granted humanitarian device exemption profit requires secretary acting director nih designate contact point office help innovators physicians identify sources funding available pediatric medical device requires secretary award grants demonstration projects promote pediatric device includes duty office_of_pediatric_therapeutics increasing pediatric access medical devices requires office report relevant congressional committees plan expanding pediatric medical device research development 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 application product development protocol condition clearance premarket notification pediatric devices prospective surveillance period months pediatric devices necessary assess impact device growth development effects growth development activity level factors safety device title provisions sec amends ffdca require secretary commissioner food_and_drugs establish publicly available clear written policies govern timely submission review clearance disclaimer requirements publication articles fda officer expresses sense senate legislation enacted provide fda authority flexibility approve subject abbreviated approval requires secretary award transferable priority review voucher sponsor tropical disease product approval secretary product establish priority review user fee prohibits secretary delaying approval new drug application petition reviewed considered delay necessary protect public health requires secretary final agency action petition later days submission delay necessary requires petitions signed contain specified sets forth reporting requirements requires hhs evaluate evidence fda compliance requirement consideration secretary petitions raise public health concerns remain separate apart review approval new drug requires commissioner annually submit congress public fda internet website report concerning results fda pesticide residue monitoring amends head start act require head_start agency obtain written parental consent administration nonemergency intrusive physical examination child connection participation head start requires fda report question substances preserve appearance fresh meat create health risks mislead 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 sec expresses sense senate fda enter contract institute_of_medicine study concerning measures taken improve likelihood fda approved drugs safe effective treating children orphan diseases rare genetic diseases available affordable pediatric requires secretary close fiscal year color certification fees collected submit congress performance report number color additives approved average turn time approval quantifiable goals improving laboratory efficiencies financial report color certification prohibits food product imported united_states product registered foreign food facility refuses permit inspectors request inspect facility unduly delays access provides certification requirement implementation prescription drug importation provisions act shall apply requirements counterfeit resistant authorizes secretary enhance necessary inspection regime fda aquaculture seafood consistent obligations international agreements expresses sense senate use available tools address violations concerns intellectual property develop submit congress strategic plan address problem countries infringing american pharmaceutical intellectual property rights engaging price requires commissioner food drugs produce report environmental risks associated genetically engineered seafood requires secretary submit relevant congressional committees report differences certain species establishes civil penalties dissemination false misleading direct consumer advertisements prescription requires secretary acting commissioner determine labeling requirements indoor tanning devices provide sufficient information consumers risks irreversible damage eyes skin including skin cancer modifying warning label required tanning beds communicate risks effectively warning capable adequately communicating risks requires secretary making determinations conduct appropriate consumer testing best available methods determining consumer understanding label warnings hold public hearings solicit comments public title food safety sec requires secretary establish processing ingredient standards respect pet food animal waste ingredient definitions update standards pet food labeling includes 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 work companies professional associations organizations collect aggregate pertinent information use existing networks communication enhance quality speed communication public post information recalled products fda website consolidated searchable form easily accessed understood requires secretary work states undertaking activities assist improving safety fresh processed requires secretary establish instances reportable adulterated food submitted fda requires secretary issue alert registry shows food associated repeated separate outbreaks illness repeatedly determined adulterated reportable adulterated food allows alert apply particular food food particular producer manufacturer shipper growing area country requires responsible party importer determines article food produced processed manufactured distributed handled reportable adulterated food provide notification parties linked supply chain submit report secretary immediately notify secretary homeland_security secretary suspects food deliberately expresses sense senate vital congress provide fda additional resources authorities direction ensure safety food supply secretary priority enter agreements trading partners respect food safety senate work develop comprehensive response issue food sets forth reporting requirements respect food products regulated authorizes appropriations title vii sec prohibits food_and_drug_administration fda restricting sale turtle farmer wholesaler commercial retail seller turtle diameter pet state territory farmer located developed regulatory process pet turtle farmers required state license state territory requires certification requires turtle treated diseases dependent proven non antibiotic methods turtle salmonella free turtle farmer commercial retail seller makes certain disclosures buyer sets forth required disclosures include information possibility salmonella turtles dangers result turtle properly handled safely maintained proper handling turtle proven methods treatment turtle safe salmonella detailed explanation properly treat turtle safe salmonella buyer continue purchase tools treatments required item continually treat turtle statement buyers pet turtles abandon turtles instead return commercial retail pet seller organization accept turtles longer wanted authorizes commissioner food drugs restrict sale turtle secretary determines actual implementation state health protections insufficient protect consumers infectious diseases acquired turtle time sale title viii importation prescription drugs pharmaceutical market access drug safety act sec amends ffdca revise provisions governing importation prescription drugs waives limitation importation prescription drugs exported united_states prohibits importation qualifying drug drug imported registered importer individual personal use defines qualifying drug drug corresponding label drug includes registration conditions importers exporters drug imported exported manufactured approved facility manufactured sale united_states permitted country chain custody exists drug exporter importer allows onsite inspections secretary proper labeling shipment importers provide prior notice shipments importers exporters pay registration fee inspection fee requires secretary inspect places business verify chain custody review records monitor shipment labels inspect facilities check compliance registration conditions sets forth provisions governing importation qualifying drugs different label drugs including standards judging differences labeling requirements establishes conditions individual importation qualifying drug including requiring valid prescription quantity exceeding day supply prohibits manufacturers discriminating registered exporters importers causing difference prescription drug distributed united_states distributed permitted country engaging actions restrict prohibit delay importation qualifying drug engaging action federal_trade_commission ftc determines discriminates person engaged importation qualifying drug allows states bring actions violations states resale united_states prescription drugs properly sold abroad patent infringement gives priority registration exporters significant canadian exporters allows secretary limit number registered exporters importers requires secretary educate consumers prescription drug requires secretary homeland_security deliver shipments secretary requires secretary destroy shipments certain requires secretary establish alternative requirements identify chain custody drug manufacturer wholesale distribution pharmacist intends sell drug retail secretary determines requirements identify chain custody identity discrete package drug dispensed equal greater certainty current requirements economically technically feasible directs secretary require use standardized anti counterfeiting track track technologies prescription drugs case level sets forth additional counterfeiting technologies incorporated prescription drug prohibits person dispensing prescription drug pursuant sale sales transaction drug conducted internet site person dispenses drug purchaser mailing shipping drug purchaser site fails meet specified requirements inclusion page links thereto providing identities licensing information seller pharmacists medical consultants prohibits person selling dispensing prescription drug purchaser communicated person internet purchaser valid prescription communication began person provided involvement practitioner practitioner issued prescription drug purchased person knew qualifying medical relationship existed defines qualifying medical relationship requiring person medical evaluation person received payment allows states bring civil actions person violations act prevents internet providers held liable dispensing selling prescription drugs account person activities includes dispensing selling prescription drug violation act prohibited act secretary award grant contract identify report internet sites violate federal state laws concerning dispensing prohibits introduction restricted transactions unregistered foreign pharmacies payment system completion transactions payment system requires board_of_governors federal_reserve_system promulgate regulations requiring designated payment systems establish policies procedures reasonably designed prevent introduction restricted transaction payment amends controlled_substances_import_and_export_act allow resident entering united_states controlled substance individual valid prescription import dosage units combined controlled directs title effective secretary certifies congress implementation pose additional risk public health safety result significant reduction cost covered products american consumer


Summary: Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting pediatric studies of new or already approved drugs to only those drugs for which the Secretary of Health and Human Services approves labeling that provides specific, therapeutically meaningful information about the use of the drug in pediatric patients. Reduces market exclusivity for such studies for drugs with sales revenue that is $1 billion or more. Prohibits the Secretary from delaying approval of a new drug application while a petition seeking any action relating to such an application is being reviewed or considered. Requires the Secretary to take final agency action on a petition within 180 days of receipt, with no extensions allowed. Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.

lower prices reduced increased competition efficient development drugs act cosmetic act require abbreviated application new drug containing certain antibiotics approved labeling includes method use claimed patent include statement identifies relevant patent approved use covered patent applicant seeking approval use requires court consider totality circumstances public interest deciding month period delays approval abbreviated drug application patent infringement case filed applicant limits market exclusivity provided conducting pediatric studies new approved drugs drugs secretary health_and_human_services approves labeling provides specific therapeutically meaningful information use drug pediatric patients reduces market exclusivity studies drugs sales revenue billion prohibits secretary delaying approval new drug application petition seeking action relating application reviewed considered requires secretary final agency action petition days receipt extensions allowed extends month period secretary approve disapprove abbreviated application new drug time date secretary receives petition date final agency action petition regard secretary grants denies petition


Summary: Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed. 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 that is not introduced onto the market within one year; and (2) create an internal review committee to review all written requests issued and all reports submitted. Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.Requires the Secretary to order the labeling of a drug to include information about the result of a pediatric study whether such study does or does not demonstrate that the drug is safe and effective.Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.Includes pediatric pharmacological research within the pediatric research loan repayment program.

amends cosmetic act changes provisions regard market exclusivity pediatric drug studies new drugs approved drugs including require appropriate labeling changes timely prohibit secretary health_and_human_services extending period market exclusivity later months prior expiration period requires applicant holder agree request conduct pediatric studies submit secretary reasons pediatric formulation developed directs secretary publish notice identifying drug pediatric formulation developed studied found safe effective introduced market year create internal review committee review written requests issued reports submitted reduces market exclusivity pediatric studies months months drugs combined annual gross sales exceed billion requires secretary order labeling drug include information result pediatric study study demonstrate drug safe effective requires comptroller general submit report congress addresses effectiveness providing market exclusivity pediatric studies ensuring medicines children tested properly labeled includes pediatric pharmacological research pediatric research loan repayment program


Summary: 340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain children's hospitals, critical access hospitals, and rural referral centers or sole community hospitals. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such prohibition, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Expands the program to include a drug used in connection with an inpatient or outpatient service by enrolled hospitals. (Currently, only outpatient drugs are covered under the program.)Requires hospitals enrolled in the 340B drug discount program to provide to each state a credit on the estimated annual costs to such hospital of single source and innovator multiple source drugs and noninnovator multiple source drugs provided to Medicaid recipients for inpatient use. Sets forth a formula for calculating the credit. Allows a hospital to avoid paying such credits under certain circumstances. Requires the Secretary to: (1) carry out activities to improve compliance by manufacturers and covered entities with the requirements of the drug discount program; and (2) establish an administrative process for resolving claims by covered entities and manufacturers of violations of such requirements.Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.

integrity act amends public_health_service_act expand drug discount program allow participation covered entity certain children hospitals critical access hospitals rural referral centers sole community hospitals prohibits enrolled hospitals obtaining covered outpatient drugs group purchasing arrangement requires secretary health_and_human_services establish reasonable exceptions prohibition including drugs unavailable program facilitate generic substitution generic covered drug available lower price expands program include drug connection inpatient outpatient service enrolled hospitals currently outpatient drugs covered hospitals enrolled 340b drug discount program provide state credit estimated annual costs hospital single source innovator multiple source drugs multiple source drugs provided medicaid recipients inpatient use sets forth formula calculating credit allows hospital avoid paying credits certain circumstances requires secretary carry activities improve compliance manufacturers covered entities requirements drug discount program establish administrative process resolving claims covered entities manufacturers violations requirements requires manufacturers offer covered entity covered drugs purchase applicable ceiling price drug available purchaser price


Summary: Dextromethorphan Distribution Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act.Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of pharmaceutical ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between authorized persons.

amends cosmetic act deem adulterated unfinished dextromethorphan possessed received distributed violation act prohibits person possessing receiving unfinished dextromethorphan person registered secretary health_and_human_services producer drug device registered licensed approved pursuant federal state law engage practice pharmacy pharmaceutical production manufacture distribution pharmaceutical ingredients distributing unfinished dextromethorphan person registered authorized person excludes prohibitions common carriers possess receive distribute unfinished dextromethorphan purposes distributing authorized persons


Summary: Amends title XVIII (Medicare) of the Social Security Act to provide for Medicare coverage of certain medical mobility devices approved as a class III medical device pursuant to a premarket approval application under the Federal Food, Drug, and Cosmetic Act.

amends title xviii medicare social security act provide medicare coverage certain medical mobility devices approved class iii medical device pursuant premarket approval application cosmetic act


Summary: Safe Tissue Act - Requires the Food and Drug Administration (FDA) to inspect, at least once every two years, each establishment that engages in the manufacture of human cells, tissues, and cellular and tissue-based products. Allows the Secretary of Health and Human Services to establish a user fee to fund such inspections. Requires the FDA to conduct periodic audits of all documentation submitted by each such establishment to determine compliance with all applicable requirements, including requirements related to ensuring: (1) that human cells, tissues, or cellular or tissue-based products are obtained legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice. Requires the Secretary to publish a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor of human cells, tissues, or cellular or tissue-based products. Sets forth penalties for failing to comply with model form requirements or for knowingly using fraudulent information. Directs the Secretary to: (1) accredit establishments and the personnel of such establishments who participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products; and (2) define "reasonable payments" that are associated with donation of human tissue and tissue-based products for purposes of the National Organ Transplant Act.

safe tissue act requires food_and_drug_administration fda inspect years establishment engages manufacture human cells tissues cellular tissue based products allows secretary health_and_human_services establish user fee fund inspections requires fda conduct periodic audits documentation submitted establishment determine compliance applicable requirements including requirements related ensuring human cells tissues cellular tissue based products obtained legally donor eligibility donor medical history interviews based accurate information provided obtained fraudulent manner current good tissue practice requires secretary publish model form containing minimum requirements establishments use obtaining consent potential donor human cells tissues cellular tissue based products sets forth penalties failing comply model form requirements knowingly fraudulent information directs secretary accredit establishments personnel establishments participate recovery processing storage labeling packaging distribution human cells tissues cellular tissue based products define reasonable payments associated donation human tissue tissue based products purposes national_organ_transplant_act


Summary: Home Oxygen Patient Protection Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to restore Medicare treatment of ownership of oxygen equipment that existed prior to the enactment of the Deficit Reduction Act of 2005. Repeals the limitation of Medicare payment to the supplier for such equipment (including portable oxygen equipment) to 36 months of continuous use.

home oxygen patient protection act amends title xviii medicare social security act restore medicare treatment ownership oxygen equipment existed prior enactment deficit reduction act repeals limitation medicare payment supplier equipment including portable oxygen equipment months continuous use