Summary: Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

protecting consumer access generic drugs act prohibits unfair deceptive act practice unfair method competition affecting interstate commerce person party agreement resolving settling patent infringement claim abbreviated new drug generic application filer receives value filer agrees research develop manufacture market sell generic drug excludes resolution settlement includes right market generic drug expiration patent exclusivity period waiver patent infringement claim damages authorizes federal_trade_commission ftc exempt agreements furtherance market competition benefit consumers amends cosmetic act provide generic drug applicant market exclusivity failing market drug days court declaratory judgment action lack subject matter jurisdiction applicant files secretary health_and_human_services covenant patent owner sue applicant patent infringement deems applicant forfeited market exclusivity applicant enters agreement violates act amends medicare_prescription_drug improvement modernization act revise reporting requirements related agreements generic drug applicant brand drug company include description subject matter agreements parties certification materials filed represent complete final exclusive agreement parties


Summary: Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.Requires the Secretary to establish a Similar Biological Products Advisory Committee.Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.

patient protection innovative biologic medicines act amends public_health_service_act allow person submit application approval biologics license biological product claimed similar qualified biological product reference product years elapsed reference product approved licensed allows secretary health_and_human_services approve similar biological product applicant demonstrates product conforms applicable final product class specific guidance secretary concludes product safe indications reference product approved effective years elapsed reference product approved licensed prohibits secretary designating similar biological product therapeutically equivalent reference product prohibits secretary approving product claimed similar reference product provision law authorizes person request issuance product class specific guidance applicable qualified biological product class requires secretary establish similar biological products advisory committee sets forth provisions governing naming biotechnology derived therapeutic protein biological products amends cosmetic act deem biotechnology derived therapeutic protein misbranded labeling fails meet requirements act


Summary: Vaccine Safety and Public Confidence Assurance Act of 2007 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services. Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.

assurance act amends public_health_service_act establish agency vaccine safety evaluation office_of_the_secretary health_and_human_services requires director conduct support safety research monitor licensed vaccines develop vaccine safety research agenda evaluate means promote compliance federal adverse reaction reporting requirements provide clearinghouse vaccine studies ensure functions relating vaccine monitoring research adverse reactions carried conflict interest oversee resolve conflicts interest related international agreements partnerships activities allows director establish program awarding fellowships research vaccine safety requires commissioner food drugs provide director request complete access vaccine related information submitted food_and_drug_administration fda vaccine manufacturers requires director require vaccine manufacturers provide surveillance clinical testing acute chronic adverse reactions associated vaccine register qualified public registry clinical trial conducted supported manufacturer respect vaccine transfers cdc responsibilities post licensure vaccine safety monitoring activities requires secretary establish advisory council agency


Summary: Mercury in Dental Fillings Disclosure and Prohibition Act - Amends the Federal Food, Drug, and Cosmetic Act to deem any drug or device to be adulterated if it contains mercury intended for use in a dental filling, effective January 1, 2009.Deems a device that contains mercury intended for use in a dental filling to be misbranded, effective December 31, 2007, unless it bears a specified warning label that it: (1) contains mercury, a highly toxic element; (2) should not be administered to children under age 18 or to pregnant or lactating women; and (3) poses health risks.

mercury disclosure prohibition act amends cosmetic act deem drug device adulterated contains mercury intended use dental filling effective january device contains mercury intended use dental filling misbranded effective december bears specified warning label contains mercury highly toxic element administered children age pregnant women poses health risks


Summary: Amputee Veteran Assistance Act - Directs the Secretary of Veterans Affairs to ensure that all Department of Veterans Affairs (VA) orthotic-prosthetic laboratories and clinics are certified by either the American Board for Certification in Orthotics and Prosthetics or the Board of Orthotics and Prosthetic Certification. Requires the Secretary to contract with a non-VA entity for the service and repair of prosthetic devices for a veteran if: (1) the Secretary determines that VA facilities are unable to perform such service or repair due to a lack of technology or any other reason; or (2) the veteran needing such service or repair resides more than 55 miles from the nearest VA facility capable of furnishing such service or repair. Directs the Secretary to: (1) develop and carry out a plan to inform disabled veterans at least twice a year of technological advances in the field of prosthetics; (2) review all VA orthotic-prosthetic laboratories and clinics to ensure that the VA is capable of servicing and repairing the most technologically advanced prosthetic devices; and (3) review VA prosthetists and orthotists to determine the level and kinds of education required to ensure their qualification to provide the most technologically advanced prosthetic devices.

amputee veteran assistance act directs secretary veterans_affairs ensure department_of_veterans_affairs orthotic prosthetic laboratories clinics certified requires secretary contract non-va entity service repair prosthetic devices veteran secretary determines facilities unable perform service repair lack technology reason veteran needing service repair resides miles nearest facility capable furnishing service repair directs secretary develop carry plan inform disabled veterans twice year technological advances field prosthetics review orthotic prosthetic laboratories clinics ensure capable servicing repairing technologically advanced prosthetic devices review determine level kinds education required ensure qualification provide technologically advanced prosthetic devices


Summary: Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

amends cosmetic act ffdca require fees collected review applications human drugs devices animal drugs deposited general fund treasury makes available amounts necessary secretary health_and_human_services review applications prohibits secretary entering agreements persons fees collected terminates existing agreements requires secretary establish food_and_drug_administration fda regulate approved drugs transfer center responsibilities regulation center_for_drug_evaluation_and_research center_for_biologics_evaluation_and_research allows secretary require manufacturers approved drugs conduct studies identified significant safety issue drug deems drug misbranded meet secretary requirements including requirements labeling conducting postmarket studies requires secretary follow interpretation fda ffdca public health service act establish minimal standards preclude additional state requirements requires secretary cease intervening product liability civil actions interpretation sets forth procedures advisory committee meetings ensure committee fairly balanced prohibits exemptions granted advisory committee members rules prohibiting members having personal financial interest outcome requires doctors inform patients obtain consent prescribe approved drug purpose approved fda


Summary: TRICARE Mail-Order Pharmacy Pilot Program Act - Directs the Secretary of Defense to conduct a two-year pilot program to educate and motivate beneficiaries to voluntarily increase their use of the TRICARE (a Department of Defense [DOD] managed care program) mail-order pharmacy. Requires the program to include at least 2,000 eligible beneficiaries in each TRICARE region, of whom at least 1,000 in each region shall be enrolled in Medicare Part B.

secretary defense conduct year pilot program educate motivate beneficiaries voluntarily increase use tricare department_of_defense dod managed care program mail order pharmacy requires program include eligible beneficiaries tricare region region shall enrolled medicare


Summary: FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA). Deems a breast implant to be a class III medical device. Requires premarket approval of breast implants irrespective of whether the implant has been cleared for commercial distribution in interstate commerce before the date of enactment of this Act.Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a a breast implant unless the applicant involved has demonstrated its safety for the life of the implant. Deems an already approved breast implant to be unsafe under the conditions of use prescribed, recommended, or suggested in the labeling. Requires the Secretary to: (1) issue appropriate, voluntary guidance for clinical care, removal, and replacement for breast implants; (2) require such guidance to be clearly expressed in the labeling and all marketing materials; and (3) require dissemination of such guidance to patients who have already received the implant. Requires the Breast Implant Advisory Panel of the General and Plastic Surgery Advisory Committee to review the results and quality of the research on saline breast implants and silicone gel implants.Requires the Secretary to study the ionization and levels of platinum in silicone breast implants.Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18.

women act amends cosmetic act establish office_of_the_commissioner food_and_drug_administration fda deems breast class iii medical device requires premarket approval breast irrespective cleared commercial distribution interstate commerce date enactment act prohibits secretary health_and_human_services finding reasonable assurance safety shown application premarket approval breast applicant involved demonstrated safety life deems approved breast unsafe conditions use prescribed recommended suggested labeling requires secretary issue appropriate voluntary guidance clinical care removal replacement breast require guidance clearly expressed labeling marketing materials require dissemination guidance patients received requires breast advisory panel review results quality research saline breast silicone requires secretary study levels platinum silicone breast requires secretary acting commissioner food_and_drugs convene scientific workshop review evaluate current scientific data use emergency contraception females childbearing potential age


Summary: Human Cloning Prohibition Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make it unlawful for any person, including a governmental entity, to: (1) perform or attempt to perform human cloning; or (2) ship, mail, transport, or receive the product of human somatic cell nuclear transfer technology knowing that such product is for the purpose of human cloning. Sets forth criminal and civil penalties for violations of this Act.

human cloning prohibition act amends cosmetic act unlawful person including governmental entity perform attempt perform human cloning ship mail transport receive product human somatic cell nuclear transfer technology knowing product purpose human cloning sets forth criminal civil penalties violations act


Summary: Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any FDA-regulated product. Establishes an exception for accepting funds from a consortium of companies whose products are FDA-regulated if the Secretary determines that such acceptance would not result in any conflict of interest and issues a waiver.

safe effective drug development act amends cosmetic act require secretary health_and_human_services acting commissioner food_and_drugs enter critical path public private partnerships eligible entities implement critical path initiative food_and_drug_administration fda developing research education outreach projects foster medical product innovation accelerate medical product development enhance medical product safety prohibits entity accepting funding technical programs critical path public private partnership individual organization manufactures distributes sells fda regulated product establishes exception accepting funds consortium companies products fda regulated secretary determines acceptance result conflict interest issues waiver


Summary: Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription.Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment.Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers.Sets forth civil penalties and establishes a a private cause of action for violations of this Act.

access birth control act amends public_health_service_act require pharmacies comply certain rules related contraceptives including providing customer contraceptive delay stock immediately informing customer contraceptive stock transferring prescription pharmacy contraceptive stock expediting ordering contraceptive notifying customer arrives based customer preference ensuring pharmacy employees certain actions relating request contraception including intimidating threatening harassing customers interfering obstructing delivery services intentionally misrepresenting deceiving customers availability contraception mechanism action breaching threatening breach medical confidentiality refusing return valid lawful prescription provides pharmacy prohibited refusing provide contraceptive customer unlawful dispense contraceptive customer valid lawful prescription prescription presented customer unable pay contraceptive employee pharmacy refuses provide contraceptive basis professional clinical judgment provides act preempt state law professional obligation state board provides greater protections customers sets forth civil penalties establishes private cause action violations act


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: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. 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 requirements, 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 entities providing maternal child health services community mental health services treatment services substance abuse medicare dependent small rural hospitals sole community hospitals rural referral centers prohibits enrolled hospitals obtaining covered outpatient drugs group purchasing arrangement requires secretary health_and_human_services establish reasonable exceptions requirements 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: Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: (1) overt optically variable counterfeit-resistant technologies into packaging; and (2) required prescription drug packaging technologies into multiple elements of the physical packaging of the drugs. Requires prescription drug shipments to include a label on the shipping container that incorporates packaging technologies. Deems a prescription drug to be misbranded if the packaging or labeling of the drug is in violation of a requirement or prohibition of this Act. Requires the Secretary to publish the National Specified List of Susceptible Prescription Drugs, consisting of not less than 30 of the most frequently counterfeited prescription drugs in the United States.

reducing fraudulent imitation drugs act directs secretary health_and_human_services require prescription drug packaging incorporate radio frequency technology similar trace track technologies tamper indicating technologies security packaging possible directs secretary require technologies exclusively authenticate prescription drugs prohibit technologies containing transmitting identifying information health care practitioner consumer advertisement information indications label uses requires secretary encourage prescription drug manufacturers distributors incorporate variable counterfeit resistant technologies packaging required prescription drug packaging technologies multiple elements physical packaging drugs requires prescription drug shipments include label shipping container incorporates packaging technologies deems prescription drug misbranded packaging labeling drug violation requirement prohibition act requires secretary publish consisting frequently prescription drugs united_states


Summary: DSHEA Full Implementation and Enforcement Act of 2007 - Authorizes and makes appropriations to: (1) carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and all applicable regulatory requirements for dietary supplements under the Federal Food, Drug, and Cosmetic Act; and (2) expand research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Food and Drug Administration (FDA) to fully and appropriately use such funds to regulate dietary supplements. Directs the Secretary of Health and Human Services to report to Congress on the implementation and enforcement of DSHEA.

implementation enforcement act authorizes makes appropriations carry applicable regulatory requirements dietary supplements cosmetic act expand research development consumer information dietary supplements national_institutes_of_health nih requires food_and_drug_administration fda fully appropriately use funds regulate dietary supplements directs secretary health_and_human_services report congress implementation enforcement


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: Unique Device Identification System for Medical Devices Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations requiring the labeling of medical devices to bear a unique identifier.

unique device identification system medical devices act amends cosmetic act require secretary health_and_human_services promulgate regulations requiring labeling medical devices bear unique identifier


Summary: Fair Balance Prescription Drug Advertisement Act of 2007 - Amends the Internal Revenue Code to disallow a tax deduction for: (1) expenses for direct-to-consumer prescription drug advertising that fails to provide adequate information on drug side effects, contraindications, or lack of effectiveness; and (2) expenses for direct-to-consumer prescription drug advertising of a new drug, a new combination of active substances, or a new delivery system for an existing drug for a two-year period after the introduction of such drug into interstate commerce.Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to report to the Secretary of the Treasury on misbranding and other violations relating to direct-to-consumer prescription drug advertising.

amends internal revenue code disallow tax deduction expenses direct consumer prescription drug advertising fails provide adequate information drug effects contraindications lack effectiveness expenses direct consumer prescription drug advertising new drug new combination active substances new delivery system existing drug year period introduction drug interstate commerce amends cosmetic act require secretary health_and_human_services report secretary treasury misbranding violations relating direct consumer prescription drug advertising


Summary: Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk evaluation and mitigation strategies; (3) preparing and making publicly available a summary analysis of the adverse drug reaction reports received for recently approved drugs; (4) conducting screenings of the Adverse Event Reporting System database and reporting on new safety concerns; and (5) developing postmarket safety performance measures. Repeals provisions limiting postmarket safety activities to the three years after approval of a new drug.(Sec. 103) Reauthorizes prescription drug user fees beginning in FY2008. Requires the Secretary of Health and Human Services to provide a partial refund of an applicant's user fees if the application is withdrawn without a waiver before filing.Sets forth special rules for positron emission tomography drugs, including subjecting an applicant in an approved human drug application for a positron emission tomography drug to one-sixth of the annual prescription drug establishment fee.Establishes the amount of revenue that fees are to generate for FY2008-FY2012. Requires that such fees be derived equally from fees related to human drug applications and supplements, prescription drug establishments, and prescription drug products. Sets forth provisions regarding adjustments to such fees. Authorizes appropriations for FY2008-FY2012.Exempts approved prescription drugs or licensed biological products designated for a rare disease or condition (orphan drugs) from product and facility fees if certain requirements are met, including having U.S. drug sales that fall below a certain amount.(Sec. 104) Requires the Secretary to assess and collect fees for advisory review of proposed direct-to-consumer television advertisements of prescription drug products. Sets forth procedures for such review.Subjects each person that is assessed an advisory review fee to an operating reserve fee. Establishes the amount of revenue that may be generated from such fees. Requires the Secretary to annually set the advisory review fee. Sets forth fee limits.Terminates the advisory review program if revenue falls below a certain threshold.Authorizes appropriations for FY2008-FY2012.(Sec. 105) Requires the Secretary to report on the progress of the Food and Drug Administration (FDA) toward achieving goals related to expediting the drug development process and the process for the review of human drug applications.(Sec. 106) Terminates provisions related to prescription drug users fees and advisory review fees on October 1, 2012.Title II: Medical Device User Fee Amendments of 2007 - (Sec. 201) Medical Device User Fee Amendments of 2007 - Subtitle A: Fees Related to Medical Devices - (Sec. 211) Defines terms relating to fees for medical devices, including defining "30-day notice" as a 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.(Sec. 212) Makes changes to medical device fees, including establishing a fee for: (1) a 30-day notice; (2) a request for classification information; and (3) periodic reporting for a class III device.Subjects each medical device establishment to a fee for each initial or annual registration beginning with its registration for FY2008, except for establishments operated by a state or federal governmental entity or an Indian tribe.Establishes the amount of revenue that may be generated from medical device fees. Makes changes to provisions related to qualifications for fee waivers for small businesses.Authorizes appropriations for FY2008-FY2012.(Sec. 213) Sets forth reporting requirements, including requiring the Secretary to report to the relevant congressional committees on the FDA's progress in achieving medical device review goals.(Sec. 214) Requires the Secretary to consult with the relevant organizations, individuals, and industry in developing recommendations for meeting goals for the process for the review of medical devices applications for fiscal years after FY2012 and for the reauthorization of provisions relating to device fees.(Sec. 215) Authorizes additional appropriations for FY2008-FY2012 to collect, develop, review, and evaluate postmarket safety information on medical devices.(Sec. 216) Makes amendments made by this title effective on the date of enactment of this title, except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notifications submissions received on or after October 1, 2007, regardless of such enactment date.(Sec. 217) Terminates amendments made by this title on October 1, 2012.Subtitle B: Amendments Regarding Regulation of Medical Devices - (Sec. 221) Extends the authority of accredited persons to review premarket reports for devices and make recommendations to the Secretary regarding the initial classification of devices.(Sec. 222) Requires any establishment within a foreign country engaged in the manufacturing, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States to annually register with the Secretary.(Sec. 223) Requires registered device producers to annually report to the Secretary with a list of new devices introduced by the registrant for commercial distribution, devices discontinued, a notice of resumption of processing of a device, and any material change in information previously submitted.(Sec. 224) Requires registrations and listings to be submitted to the Secretary electronically unless the Secretary grants a waiver of such requirement.(Sec. 225) Directs the Comptroller General to study the appropriate use of the process requiring registrants to report to the Secretary before introduction of a device into interstate commerce on the classification of the device.(Sec. 226) Requires the Secretary to promulgate regulations establishing a unique identification system for medical devices.(Sec. 227) Makes changes to reporting requirements for devices that have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.(Sec. 228) Requires a person accredited to conduct inspections of device establishments to notify the Secretary within 30 days of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems for any inspected establishment. Sets forth conditions that a device establishment must meet to be eligible for inspections by accredited persons.(Sec. 229) Directs the Comptroller General to study and report on nosocomial infections attributed to new and reused medical devices and the causes of such infections.Title III: Pediatric Medical Device Safety and Improvement Act of 2007- (Sec. 301) Pediatric Medical Device Safety and Improvement Act of 2007 - (Sec. 302) Requires applications for a humanitarian device exemption, an application for premarket approval of a medical device, or a product development protocol for a medical device to include, if readily available: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Requires the Secretary to submit to the relevant congressional committees an annual report that includes: (1) the number of devices approved in the preceding year for which there is a pediatric subpopulation that suffers from the disease; (2) the number of approved devices labeled for use in pediatric patients; (3) the number of fee-exempt devices approved; and (4) the review time for each approved device.Authorizes the Secretary to conclude that adult data on medical devices may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations if the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients.(Sec. 303) Excludes a person granted a humanitarian device exemption from the prohibition against selling such a medical device for an amount that exceeds its research and development, fabrication, and distribution costs if: (1) the device is intended to treat or diagnose a disease or condition that occurs in pediatric patients; (2) the device was not approved for pediatric patients prior to enactment of this Act; (3) the number of devices distributed does not exceed an annual distribution number specified by the Secretary; and (4) the request for exemption is submitted on or before October 1, 2013.Requires the Secretary to: (1) refer any adverse event report related to a device to the Office of Pediatric Therapeutics for review; and (2) provide for an annual review by the Pediatric Advisory Committee of all devices subject to the humanitarian device exemption to ensure that such exemption remains appropriate for the pediatric population for which it is granted.Directs the Comptroller General to report on the impact of allowing persons granted a humanitarian device exemption to profit from such a device.(Sec. 304) Requires the Director of National Institutes of Health (NIH) to designate a contact point to help innovators and physicians access funding for pediatric medical device development.Requires the Commissioner of Food and Drugs to report to the relevant congressional committees a plan for expanding pediatric medical device research and development.(Sec. 305) Requires the Secretary to award grants or contracts for demonstration projects to promote pediatric device development.Authorizes appropriations for FY2008-FY2012.(Sec. 306) Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Expands the duties of the advisory committee on pediatric therapeutics to include providing advice and recommendations on matters relating to medical devices.(Sec. 307) Allows the Secretary to require: (1) postmarket surveillance as a condition to approval or clearance of certain medical devices; (2) postmarket surveillance on class II or class III medical devices that are indicated for, or have significant use in, pediatric populations; and (3) a prospective surveillance period of more than 36 months for a device that is expected to have significant use in pediatric populations.Title IV: Pediatric Research Equity Act of 2007 - (Sec. 401) Pediatric Research Equity Act of 2007 - (Sec. 402) Requires an applicant seeking to defer submission of some or all pediatric assessments of the safety and effectiveness of a new drug or biological product to submit to the Secretary a timeline for the completion of pediatric studies. Sets forth annual reporting requirements for an applicant following the approval of such a deferral.Requires an applicant seeking a full or partial waiver of pediatric assessment submission requirements to submit to the Secretary documentation detailing why a pediatric formulation cannot be developed.Authorizes the Secretary to require submission of a pediatric assessment if the Secretary finds that: (1) adequate pediatric labeling could confer a benefit on pediatric patients; or (2) the absence of adequate pediatric labeling could pose a risk (currently, significant risk) to pediatric patients.Directs the Secretary to utilize an internal committee to consult with reviewing divisions on: (1) all pediatric plans and assessments prior to approval of an application or supplement for which a pediatric assessment is required; and (2) all deferral and waiver requests granted.Requires the Secretary to track and make publicly available information related to pediatric assessments, including: (1) the number of assessments conducted; (2) the specific drugs and biological products and uses assessed; (3) the number of deferrals requested and granted; and (4) the labeling changes made as a result of such assessments. Considers a supplement to any new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority application or supplement. Sets forth dispute resolution procedures if the Commissioner and the sponsor are unable to reach agreement on appropriate labeling changes for such drug.Requires the Secretary to: (1) order the label of a product to include information about the results of the assessment and a statement that a pediatric assessment does or does not demonstrate that the drug is safe and effective in pediatric populations; (2) make publicly available the pharmacology reviews of pediatric assessments; (3) require the sponsors of the assessments that result in labeling changes to distribute such information to physicians and other heath care providers; and (4) ensure that all adverse event reports that have been received for a drug are referred to the Office of Pediatric Therapeutic for review.Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding the pediatric studies and the labeling changes made as a result of such studies.(Sec. 403) Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of FFDCA pediatric research provisions in ensuring that medicines used by children are tested and properly labeled.Title V: Best Pharmaceuticals for Children Act of 2007 - (Sec. 501) Best Pharmaceuticals for Children Act of 2007 - (Sec. 502) Amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding market exclusivity for pediatric drug studies on new or already approved drugs, including to: (1) change the definition of "pediatric studies" to authorize the Secretary to include preclinical studies; (2) require that the studies are completed using appropriate formulations for each age group for which such a study is requested; (3) require that appropriate labeling changes are made within a time frame requested by the Secretary; and (4) prohibit the Secretary from extending the period of market exclusivity later than one year prior to the expiration of the period.Requires an applicant or holder that does not agree to the request for a pediatric study to submit to the Secretary the reasons such pediatric formulations cannot be developed. Requires an applicant or holder that agrees to such a request to provide the Secretary with all postmarket adverse event reports regarding the drug. Extends to 180 days (currently, 90 days) the period the Secretary has to accept or reject reports on pediatric studies and notify the sponsor or holder.Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if the pediatric formulation is not introduced onto the market within one year after the determination regarding market exclusivity; (2) establish an internal committee to review all written requests for pediatric studies issued; (3) track and make publicly available information on the pediatric studies conducted; (4) order the labeling of a product to include information about the results of the study and a statement that a pediatric study does or does not demonstrate that the drug is safe and effective in pediatric populations; and (5) ensure that all adverse event reports that have been received for a drug are referred to the Office of Pediatric Therapeutics.Sets forth actions for the Secretary to take if pediatric studies have not been completed and there is a continuing need for information relating to the use of the drug in the pediatric population.Requires the Secretary to contract with the Institute of Medicine to study and report to Congress regarding written requests for pediatric studies made and the studies conducted.Requires the Secretary, acting through the Director of NIH, to: (1) develop and publish a priority list of needs in pediatric therapeutics, including drugs or indications that need study; and (2) study and report to Congress on the feasibility of establishing a compilation of information on pediatric drug use.Authorizes appropriations.Includes activities relating to the support of studies of drugs on pediatric populations within the process for the review of human drug applications.Authorizes the Foundation for the National Institutes of Health to solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of activities relating to studies on the Secretary's priority list of needs in pediatric therapeutics. Amends the Best Pharmaceuticals for Children Act to require the advisory committee on pediatric therapeutics to continue to operate for five years after enactment of this Act. Requires the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to: (1) provide recommendations to the internal committee that reviews pediatric research requests with respect to the treatment of pediatric cancer; and (2) continue to operate for five years after enactment of this Act. Sets forth reporting requirements.Directs that the proposed rule issued by the Commissioner entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" take effect on January 1, 2008, unless the final rule is issued before such date. Title VI: Reagan-Udall Foundation - (Sec. 601) Establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. Requires the Foundation to: (1) identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness of such products; (2) establish goals and priorities; (3) identify federal research and development programs and minimize duplication; (4) award grants to scientists and entities to efficiently and effectively advance such goals and priorities; and (5) provide objective clinical and scientific information to the FDA and other federal agencies.(Sec. 602) Requires the Secretary to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4) develop a peer review process by which intramural research can be evaluated; and (5) identify and solicit intramural research proposals from across the FDA.(Sec. 603) Requires the Secretary, acting through the Commissioner, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of FDA by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Authorizes appropriations for FY2008-FY2012.Title VII: Conflicts of Interest - (Sec. 701) Directs the Secretary, through the Office of Women's Health, the Office of Orphan Product Development, the Office of Pediatric Therapeutics, and other relevant offices within FDA, to develop and implement strategies on effective outreach to potential members of advisory committees. Requires the Secretary to review the expertise and financial disclosure report of an individual when considering an appointment to an advisory committee. Prohibits any member of an advisory committee from voting on any matter in which the member has a financial interest without a waiver by the Secretary. Title VIII: Clinical Trials Databases - (Sec. 801) Amends the Public Health Service Act to require the Secretary, acting through the Director of NIH, to establish and administer a clinical trials registry database and a clinical trials results database. Requires the responsible party for an applicable clinical trial to submit the relevant information and periodic updates to the Director of NIH for inclusion in the databases. Sets forth penalties for failure to submit the required clinical trial information and for the submission of false or misleading information. Authorizes appropriations.Prohibits a state or political subdivision from establishing any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database.(Sec. 802) Requires the Comptroller General to study whether information on the trials registry and database is considered promotional and to evaluate the implementation of the database.Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs - (Sec. 901) Prohibits a responsible person from introducing into interstate commerce a new drug if the person is in violation of a requirement related to postapproval clinical trials or labeling changes.Authorizes the Secretary to: (1) require a responsible person for a drug to conduct a postapproval study or clinical trial of the drug to assess a known serious risk or signals of serious risk or to identify such a risk; (2) require a postapproval study or trial for an already approved drug only if the Secretary becomes aware of new safety information; and (3) issue an order directing a responsible person to make a labeling change to address new safety information. Sets forth procedures for dispute resolution.Prohibits a person from introducing into interstate commerce a new drug or biological product for which a risk evaluation and mitigation strategy is required if: (1) the person fails to maintain compliance with the requirements of such strategy; or (2) does not cooperate in developing such a strategy.Prohibits the Secretary from approving the application for a new drug or a biological products license unless the person involved has submitted a statement as to whether a risk evaluation and mitigation strategy and a postmarket study or clinical trial should be required. Requires a person to submit a risk evaluation and mitigation strategy as part of the application if determined necessary to ensure that the benefits of the drug involved outweigh the risks. Sets forth factors the Secretary must consider in making such a determination.Requires a proposed risk evaluation and management strategy to include a timetable for assessment of the strategy. Allows the Secretary to require such a strategy to include additional elements, including: (1) distribution to each patient of a Medication Guide and a patient package insert; (2) a communication plan to health care providers; and (3) restrictions on distribution.Requires the elements of a risk evaluation and mitigation strategy to be commensurate with a specific serious risk listed in the labeling of the drug.Establishes the Drug Safety Oversight Board.Authorizes the Secretary to: (1) require the submission of any television advertisement for a drug for review before dissemination; (2) recommend but not require changes in such advertisements; and (3) require inclusion in advertisements of certain disclosures about a serious risk listed in the labeling of the drug. Requires the Secretary to establish a permanent advisory committee to advise the Secretary on a report to Congress on direct-to-consumer advertising and its ability to communicate to subsets of the general population.(Sec. 902) Deems to be misbranded a drug: (1) subject to an approved risk evaluation and mitigation strategy if the responsible person fails to comply with the strategy's requirements; or (2) if the responsible person is in violation of a requirement relating to postmarket studies and clinical trials or labeling.(Sec. 903) Authorizes the Secretary to withdraw or suspend the approval of a new drug application without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy.(Sec. 904) Directs the Commissioner to report to Congress on how best to communicate to the public the risks and benefits of new drugs and the role of the risk evaluation and mitigation strategy in assessing such risks and benefits.(Sec. 905) Requires the Secretary to establish public-private partnerships to develop tools and methods to enable the Secretary and others to use available electronic databases to create a robust surveillance system that will support active surveillance on important drug safety questions. Authorizes appropriations for FY2008-FY2012.Requires the Comptroller General to evaluate data confidentiality and security issues relating to collection, transmission, and maintenance of data for the surveillance system under this Act and make recommendations to relevant congressional committees regarding the need for any additional legislative or regulatory actions to ensure confidentiality and security.(Sec. 907) Deems a drug or device to be misbranded if a direct-to-consumer advertisement does not include a specified statement related to reporting adverse effects.(Sec. 908) Requires the Secretary, acting through the Commissioner, to issue guidance for the conduct of clinical trials with respect to antibiotic drugs.(Sec. 909) Prohibits the introduction into interstate commerce of any food to which has been added an approved drug, a licensed biological product, or certain other drugs or biological products unless: (1) such drug or biological product was marketed in food prior to approval, licensure, or clinical investigation; or (2) the Secretary has issued a regulation approving the addition of such drug or biological product to food.(Sec. 910) Requires the Secretary to: (1) develop standards to secure the prescription drug distribution system against counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs; (2) prioritize and develop standards for the identification, validation, authentication, and tracking of prescription drugs; and (3) expand the Office of Regulatory Affairs of the FDA to protect the prescription drug distribution system.(Sec. 911) Directs the Commissioner to convene a public meeting regarding which serious and life threatening infectious diseases potentially qualify for available grants and contracts under the Orphan Drug Act or other incentives for development.Amends the Orphan Drug Act to reauthorize appropriations for grants and contracts to defray the costs of: (1) qualified testing expenses incurred in connection with the development of drugs for rare diseases and conditions, (2) developing medical devices for rare diseases or conditions, and (3) developing medical foods for rare diseases or conditions.Authorizes appropriations for FY2008-FY2012 for grants under the Orphan Drug Act. (Sec. 912) Prohibits the Secretary from delaying approval of an application on the basis of a citizen petition unless the Secretary determines that a delay is necessary to protect the public health and provides the applicant with a written explanation of the reasons for the delay. (Sec. 913) Authorizes additional appropriations for FY2008-FY2012 for carrying out this title.(Sec. 914) Makes this title effective 180 days after enactment. Deems already approved drugs to have an approved risk evaluation and mitigation strategy if specified restrictions on distribution or use are in effect, but requires the holder of such an approved drug application to submit a proposed risk evaluation and mitigation strategy within 180 days.

title prescription drug user fee amendments sec prescription drug user fee amendments sec amends cosmetic act ffdca include postmarket safety activities process review human drug applications supplements including developing improved adverse event data collection systems improved analytical tools assess potential safety problems implementing enforcing provisions relating studies clinical trials labeling changes risk evaluation mitigation strategies preparing making publicly available summary analysis adverse drug reaction reports received recently approved drugs conducting screenings database reporting new safety concerns developing postmarket safety performance measures repeals provisions limiting postmarket safety activities years approval new reauthorizes prescription drug user fees beginning fy2008 requires secretary health_and_human_services provide partial refund applicant user fees application withdrawn waiver filing sets forth special rules positron emission tomography drugs including subjecting applicant approved human drug application positron emission tomography drug sixth annual prescription drug establishment fee establishes revenue fees generate fy2008 fy2012 requires fees derived equally fees related human drug applications supplements prescription drug establishments prescription drug products sets forth provisions adjustments fees authorizes appropriations fy2008 approved prescription drugs licensed biological products designated rare disease condition orphan drugs product facility fees certain requirements met including having drug sales fall certain requires secretary assess collect fees advisory review proposed direct consumer television advertisements prescription drug products sets forth procedures review subjects person assessed advisory review fee operating reserve fee establishes revenue generated fees requires secretary annually set advisory review fee sets forth fee limits terminates advisory review program revenue falls certain threshold authorizes appropriations fy2008 requires secretary report progress food_and_drug_administration fda achieving goals related expediting drug development process process review human drug terminates provisions related prescription drug users fees advisory review fees october medical device user fee amendments sec medical device user fee amendments subtitle fees related medical devices sec defines terms relating fees medical devices including defining day notice supplement approved premarket application premarket report limited request modifications manufacturing procedures methods affecting safety effectiveness makes changes medical device fees including establishing fee day notice request classification information periodic reporting class iii device subjects medical device establishment fee initial annual registration beginning registration fy2008 establishments operated state federal governmental entity indian tribe establishes revenue generated medical device fees makes changes provisions related qualifications fee waivers small businesses authorizes appropriations fy2008 sets forth reporting requirements including requiring secretary report relevant congressional committees fda progress achieving medical device review requires secretary consult relevant organizations individuals industry developing recommendations meeting goals process review medical devices applications fiscal years fy2012 reauthorization provisions relating device authorizes additional appropriations fy2008 fy2012 collect develop review evaluate postmarket safety information medical makes amendments title effective date enactment title fees shall assessed premarket applications premarket reports supplements premarket notifications submissions received october regardless enactment terminates amendments title october amendments regulation medical devices sec extends authority accredited persons review premarket reports devices recommendations secretary initial classification requires establishment foreign country engaged manufacturing propagation compounding processing drug device imported offered import united_states annually register requires registered device producers annually report secretary list new devices introduced registrant commercial distribution devices discontinued notice resumption processing device material change information previously requires registrations listings submitted secretary electronically secretary grants waiver directs comptroller general study appropriate use process requiring registrants report secretary introduction device interstate commerce classification requires secretary promulgate regulations establishing unique identification system medical makes changes reporting requirements devices likely cause contribute death injury requires person accredited conduct inspections device establishments notify secretary days withdrawal suspension restriction expiration certificate conformance quality systems inspected establishment sets forth conditions device establishment meet eligible inspections accredited directs comptroller general study report infections attributed new medical devices causes infections title iii pediatric medical device safety improvement act sec pediatric medical device safety improvement act sec requires applications humanitarian device exemption application premarket approval medical device product development protocol medical device include readily available description pediatric subpopulations suffer disease condition device intended treat diagnose cure number affected pediatric patients requires secretary submit relevant congressional committees annual report includes number devices approved preceding year pediatric subpopulation suffers disease number approved devices labeled use pediatric patients number fee exempt devices approved review time approved device authorizes secretary conclude adult data medical devices support determination reasonable assurance effectiveness pediatric populations course disease condition effects device sufficiently similar adults pediatric excludes person granted humanitarian device exemption prohibition selling medical device exceeds research development fabrication distribution costs device intended treat diagnose disease condition occurs pediatric patients device approved pediatric patients prior enactment act number devices distributed exceed annual distribution number specified secretary request exemption submitted october secretary refer adverse event report related device office_of_pediatric_therapeutics review provide annual review pediatric_advisory_committee devices subject humanitarian device exemption ensure exemption remains appropriate pediatric population granted directs comptroller general report impact allowing persons granted humanitarian device exemption profit requires director national_institutes_of_health nih designate contact point help innovators physicians access funding pediatric medical device development requires commissioner food drugs report relevant congressional committees plan expanding pediatric medical device research requires secretary award grants contracts demonstration projects promote pediatric device development authorizes appropriations fy2008 includes duty office_of_pediatric_therapeutics increasing pediatric access medical devices expands duties advisory committee pediatric include providing advice recommendations matters relating medical allows secretary require postmarket surveillance condition approval clearance certain medical devices postmarket surveillance class class iii medical devices indicated significant use pediatric populations prospective surveillance period months device expected significant use pediatric populations title pediatric research equity act sec pediatric research equity act sec requires applicant seeking defer submission pediatric assessments safety effectiveness new drug biological product submit secretary timeline completion pediatric studies sets forth annual reporting requirements applicant following approval deferral requires applicant seeking partial waiver pediatric assessment submission requirements submit secretary documentation detailing pediatric formulation developed authorizes secretary require submission pediatric assessment secretary finds adequate pediatric labeling confer benefit pediatric patients absence adequate pediatric labeling pose risk currently significant risk pediatric patients directs secretary utilize internal committee consult reviewing divisions pediatric plans assessments prior approval application supplement pediatric assessment required deferral waiver requests granted requires secretary track publicly available information related pediatric assessments including number assessments conducted specific drugs biological products uses assessed number deferrals requested granted labeling changes result assessments considers supplement new drug biological license application proposing labeling change result pediatric assessments priority application supplement sets forth dispute resolution procedures commissioner sponsor unable reach agreement appropriate labeling changes drug requires secretary order label product include information results assessment statement pediatric assessment demonstrate drug safe effective pediatric populations publicly available pharmacology reviews pediatric assessments require sponsors assessments result labeling changes distribute information physicians heath care providers ensure adverse event reports received drug referred review requires secretary contract institute_of_medicine study report congress pediatric studies labeling changes result requires comptroller general submit report congress addresses effectiveness ffdca pediatric research provisions ensuring medicines children tested properly labeled title best pharmaceuticals children act sec best pharmaceuticals children act sec amends cosmetic act revise provisions market exclusivity pediatric drug studies new approved drugs including change definition pediatric studies authorize secretary include preclinical studies require studies completed appropriate formulations age group study requested require appropriate labeling changes time frame requested secretary prohibit secretary extending period market exclusivity later year prior expiration period requires applicant holder agree request pediatric study submit secretary reasons pediatric formulations developed requires applicant holder agrees request provide secretary postmarket adverse event reports drug extends days currently days period secretary accept reject reports pediatric studies notify sponsor holder directs secretary publish notice identifying drug pediatric formulation developed studied found safe effective pediatric population pediatric formulation introduced market year determination market exclusivity establish internal committee review written requests pediatric studies issued track publicly available information pediatric studies conducted order labeling product include information results study statement pediatric study demonstrate drug safe effective pediatric populations ensure adverse event reports received drug referred office_of_pediatric_therapeutics sets forth actions secretary pediatric studies completed continuing need information relating use drug pediatric population requires secretary contract institute_of_medicine study report congress written requests pediatric studies studies conducted requires secretary acting director nih develop publish priority list needs pediatric including drugs indications need study study report congress feasibility establishing compilation information pediatric drug use authorizes appropriations includes activities relating support studies drugs pediatric populations process review human drug applications authorizes foundation national_institutes_of_health solicit accept gifts grants donations establish accounts invest expend funds support activities relating studies secretary priority list needs pediatric amends best pharmaceuticals children act require advisory committee pediatric continue operate years enactment act requires provide recommendations internal committee reviews pediatric research requests respect treatment pediatric cancer continue operate years enactment act sets forth reporting requirements directs proposed rule issued commissioner entitled toll free number reporting adverse events labeling human drug products effect january final rule issued date title sec establishes reagan udall foundation food_and_drug_administration nonprofit corporation advance mission fda modernize medical veterinary food food ingredient cosmetic product development accelerate innovation enhance product safety requires foundation identify unmet needs development manufacture evaluation safety effectiveness products establish goals priorities identify federal research development programs minimize duplication award grants scientists entities efficiently effectively advance goals priorities provide objective clinical scientific information fda federal requires secretary establish office chief scientist oversee coordinate ensure quality regulatory focus fda intramural research programs track coordinate intramural research awards fda center science based office develop advocate budget support intramural research develop peer review process intramural research evaluated identify solicit intramural research proposals requires secretary acting commissioner enter critical path public private partnerships eligible entities implement critical path initiative fda developing research education outreach projects foster medical product innovation accelerate medical product development enhance medical product safety authorizes appropriations fy2008 vii conflicts interest sec directs secretary office_of_pediatric_therapeutics relevant offices fda develop implement strategies effective outreach potential members advisory committees requires secretary review expertise financial disclosure report individual considering appointment advisory committee prohibits member advisory committee voting matter member financial interest waiver secretary title viii sec amends public_health_service_act require secretary acting director nih establish administer clinical trials registry database clinical trials results database requires responsible party applicable clinical trial submit relevant information periodic updates director nih inclusion databases sets forth penalties failure submit required clinical trial information submission false misleading information authorizes appropriations prohibits state political subdivision establishing requirement registration clinical trials inclusion information relating results clinical trials requires comptroller general study information trials registry database considered promotional evaluate implementation database title sec prohibits responsible person introducing interstate commerce new drug person violation requirement related clinical trials labeling changes authorizes secretary require responsible person drug conduct study clinical trial drug assess known risk signals risk identify risk require study trial approved drug secretary aware new safety information issue order directing responsible person labeling change address new safety information sets forth procedures dispute resolution prohibits person introducing interstate commerce new drug biological product risk evaluation mitigation strategy required person fails maintain compliance requirements strategy cooperate developing strategy prohibits secretary approving application new drug biological products license person involved submitted statement risk evaluation mitigation strategy postmarket study clinical trial required requires person submit risk evaluation mitigation strategy application determined necessary ensure benefits drug involved outweigh risks sets forth factors secretary consider making determination requires proposed risk evaluation management strategy include timetable assessment strategy allows secretary require strategy include additional elements including distribution patient patient package insert communication plan health care providers restrictions distribution requires elements risk evaluation mitigation strategy commensurate specific risk listed labeling drug establishes drug safety oversight board authorizes secretary require submission television advertisement drug review dissemination recommend require changes advertisements require inclusion advertisements certain disclosures risk listed labeling drug requires secretary establish permanent advisory committee advise secretary report congress direct consumer advertising ability communicate general deems misbranded drug subject approved risk evaluation mitigation strategy responsible person fails comply strategy requirements responsible person violation requirement relating postmarket studies clinical trials authorizes secretary withdraw suspend approval new drug application ordering applicant submit assessment approved risk evaluation mitigation directs commissioner report congress best communicate public risks benefits new drugs role risk evaluation mitigation strategy assessing risks requires secretary establish public private partnerships develop tools methods enable secretary use available electronic databases create robust surveillance system support active surveillance important drug safety questions authorizes appropriations fy2008 comptroller general evaluate data confidentiality security issues relating collection transmission maintenance data surveillance system act recommendations relevant congressional committees need additional legislative regulatory actions ensure confidentiality deems drug device misbranded direct consumer advertisement include specified statement related reporting adverse requires secretary acting commissioner issue guidance conduct clinical trials respect antibiotic prohibits introduction interstate commerce food added approved drug licensed biological product certain drugs biological products drug biological product marketed food prior approval licensure clinical investigation secretary issued regulation approving addition drug biological product requires secretary develop standards secure prescription drug distribution system counterfeit diverted substandard adulterated misbranded expired drugs prioritize develop standards identification validation authentication tracking prescription drugs expand fda protect prescription drug distribution directs commissioner convene public meeting life threatening infectious diseases potentially qualify available grants contracts orphan drug act incentives development amends orphan drug act reauthorize appropriations grants contracts defray costs qualified testing expenses incurred connection development drugs rare diseases conditions developing medical devices rare diseases conditions developing medical foods rare diseases conditions authorizes appropriations fy2008 fy2012 grants orphan drug act sec prohibits secretary delaying approval application basis citizen petition secretary determines delay necessary protect public health provides applicant written explanation reasons delay sec authorizes additional appropriations fy2008 fy2012 carrying makes title effective days enactment deems approved drugs approved risk evaluation mitigation strategy specified restrictions distribution use effect requires holder approved drug application submit proposed risk evaluation mitigation strategy days


Summary: Drug and Medical Device Company Gift Disclosure Act - Amends the Federal Food, Drug, and Cosmetic Act to require prescription drug or medical device manufacturers, packers, and distributors to annually disclose to the Commissioner of Food and Drugs the value, nature, and purpose of any : (1) gift made in connection with detailing, promotion, or other marketing activity to any physician, nurse, therapist, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe or dispense prescription drugs; and (2) cash rebate, discount, or other financial consideration given to any pharmaceutical benefit manager in connection with such marketing activities. Defines "gift" to include any fee, payment, subsidy, amenity, object, service, or other economic benefit, except: (1) free samples of prescription drugs; (2) reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial; and (3) certain scholarships or other support for medical students, residents, or fellows to attend conferences. Applies such provisions only if the total value of the gift or gifts is $50 or more during the calendar year. Requires the Commissioner to: (1) make such information available to the public; and (2) keep confidential any information related to a trade secret. Establishes civil penalties for violations.Gives the Commissioner authority to investigate compliance with this Act. Authorizes the Commissioner to file a petition in the United States District Court for an order requiring submission of a report or other appropriate relief.

drug medical device company gift disclosure act amends cosmetic act require prescription drug medical device manufacturers packers distributors annually disclose commissioner food drugs value nature purpose gift connection detailing promotion marketing activity physician nurse therapist hospital nursing home pharmacist health benefit plan administrator person authorized prescribe dispense prescription drugs cash rebate discount financial consideration given pharmaceutical benefit manager connection marketing activities defines gift include fee payment subsidy object service economic benefit free samples prescription drugs reasonable compensation reimbursement expenses connection bona fide clinical trial certain scholarships support medical students residents fellows attend conferences applies provisions total value gift gifts calendar year requires commissioner information available public confidential information related trade secret establishes civil penalties violations gives commissioner authority investigate compliance act authorizes commissioner file petition united_states_district_court order requiring submission report appropriate relief


Summary: Skin Cancer Prevention, Education, and Consumer Right-To-Know Act - Amends the Federal Food, Drug, and Cosmetic Act to deem a drug that is a sunscreen product whose labeling violates this Act to be adulterated.Prohibits the labeling of a drug that is a sunscreen product that fails to meet the standards adopted under this Act from: (1) describing the product using the term "broad-spectrum"; or (2) including a specified symbol adopted to indicate broad-spectrum.Requires the Secretary of Health and Human Services to adopt: (1) a standard for broad-spectrum protection in sunscreen products; and (2) an easily recognized symbol for inclusion in the labeling of sunscreen products meeting such standards.Sets forth minimum standards that the Secretary shall adopt for such broad-spectrum protection, including a minimum ratio of UVA protection factor to sun protection factor, a minimum level of UVB radiation protection, and specified truth in labeling requirements. Requires sun protection factors to be measured using standardized, reproducible testing methods that take photo-degradation into account.Requires the Secretary to implement an education campaign identifying the risks posed by sun exposure without the use of a sunscreen providing broad-spectrum protection.

skin cancer prevention education consumer right know act amends cosmetic act deem drug sunscreen product labeling violates act adulterated prohibits labeling drug sunscreen product fails meet standards adopted act describing product term broad spectrum including specified symbol adopted indicate broad spectrum requires secretary health_and_human_services adopt standard broad spectrum protection sunscreen products easily recognized symbol inclusion labeling sunscreen products meeting standards sets forth minimum standards secretary shall adopt broad spectrum protection including minimum ratio protection factor sun protection factor minimum level radiation protection specified truth labeling requirements requires sun protection factors measured standardized testing methods photo degradation account requires secretary implement education campaign identifying risks posed sun exposure use sunscreen providing broad spectrum protection


Summary: Voluntary State Discount Prescription Drug Plan Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program.

plan act amends title xix medicaid social security act require drug manufacturers pay rebates state prescription drug discount programs condition participating medicaid rebate agreement outpatient prescription drugs state elected establish optional state prescription drug discount program


Summary: Community Clinical Laboratory Fairness in Competition Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to repeal the mandate for a Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services. Amends federal civil service to subject the Centers for Medicare & Medicaid Services of the Department of Health and Human Services (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) to the requirement to submit to a small business advocacy review panel for comment any proposed rule which will have a significant economic impact on a substantial number of small entities.

competition act amends title xviii medicare social security act repeal mandate medicare competitive bidding demonstration project clinical laboratory services amends federal civil service subject centers department_of_health_and_human_services solely respect capacity issue rules governing medicare fee schedule clinical laboratory services requirement submit small business advocacy review panel comment proposed rule significant economic impact substantial number small entities