S. 1082 would amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions.

== Detailed Summary ==

<summary>
PrescriptionFood and Drug Administration Revitalization Act - <b>Title I: Prescription Drug User Fees</b> - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to make changes to provisions governingset forth as a purpose that authorized prescription drug user fees.fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety.

Removes provisions limitingSets forth reporting requirements, including requiring the postmarket safety activities on approvedSecretary of Human Services to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications to three years after approvaland for reauthorization of a new drug.user fee provisions.

Sets forth provisions regarding user feesMakes changes to include postmarket safety activities within the process for the review of approved human drug applications or supplements, including developing and supplements that the Secretary of Healthusing improved adverse event data collection systems and Human Services must collect beginning in FY2008, includingimproved analytical tools to assess potential safety problems. Removes provisions limiting the amount of revenue that such fees arepostmarket safety activities to generate and relevant adjustments to such fees.three years after approval of a new drug.

Requires the Secretary to assess and collect fees for advisory review by the Secretary of direct-to-consumer television advertisements for a(Sec. 103) Reauthorizes 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 yearnew users fees beginning in which an advisory review fee is assessed.FY2008.

Requires the Secretary to: (1) annually set the fee for advisory review based on the numberto provide a partial refund of direct-to-consumer advertisements that the Secretary will review in the next fiscal year; and (2) establish a Direct-to-Consumer Advisory Review Operating Reserve in the Food and Drug Administration (FDA) salaries and expenses appropriation account to continue such advisory review program in the event thean applicant's user fees collected in any subsequent fiscal year do not generate the fee revenue amount established for that fiscal year. Terminates the program if the Secretary fails to receiveapplication is withdrawn without a certain amount of advisory review fees and operating reserve fees.waiver before filing.

TerminatesSets 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-quarter of the annual prescription drug establishment fee.

Establishes the amount of revenue that fees are to generate for FY2008-FY2012. Sets forth provisions governingregarding 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.

<b>Title II: Drug Safety</b> - (Sec. 201) Enhancing Drug Safety and Innovation Act of 2007- <b>Subtitle A: Risk Evaluation and Mitigation Strategies</b> - (Sec. 201) Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to facilitate a public-private partnership to: (1) implement a routine active monitoring system for postmarket drug safety; and (2) 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. Requires such partnership to: (1) develop a mechanism for the pooling of relevant data from federal and private electronic health care population databases; (2) support the routine and systematic collection and analysis of utilization and prescription drug safety data; and (3) allow for prompt investigation of priority drug safety questions, including unresolved safety questions for drugs or classes of drugs. Requires the Secretary to: (1) develop, support, and participate in other approaches to gather and analyze data and information relevant to priority drug safety questions; (2) develop and implement best practices in epidemiology and the use of approved analytic tools; and (3) engage independent private research groups to conduct analyses of data relating to priority drug safety questions.

(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) prohibiting applicants from issuing direct-to-consumer advertisements for a fixed period; and (4) restrictions on distribution under certain circumstances. 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. 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 advise to the Secretary on the management of important drug safety issues.

(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 an applicant who knowingly fails to comply with a requirement of an approved risk evaluation and mitigation 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; (5) a temporary moratorium on direct-to-consumer advertising; and (6) restrictions on distribution or use.

(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.

Amends provisions related to workload adjustments to include under the process for reviewing and assessing risk evaluation and mitigation strategies: (1) determinations related to the total number of assessments of risk evaluation and mitigation strategies submitted to the Secretary; and (2) uses of dispute resolution.

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 change. Requires the Drug Safety Oversight Board to resolve such disputes, as necessary.

(Sec. 209) Requires the Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health (NIH), to establish a searchable, publicly accessible repository of structured, electronic product information, including the approved professional labeling and any required patient labeling of each approved drug or licensed biological product. Sets forth reporting requirements.

(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.

(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.

<b>Subtitle B: Reagan-Udall Foundation for the Food and Drug Administration</b> - (Sec. 221) Establishes the Reagan-Udall Foundation 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.

<b>Subtitle C: Clinical Trials</b> - (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.

<b>Subtitle D: Conflicts of Interest</b> - (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.

<b>Subtitle E: Other Drug Safety Provisions</b> - (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.

<b>Title III: Medical Devices</b> - (Sec. 301) Medical Device User Fee Amendments of 2007 - <b>Subtitle A: Device User Fees</b> - (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.

<b>Subtitle B: Amendments Regarding Regulation of Medical Devices</b> - (Sec. 311) Requires a person accredited to conduct inspections of establishments that manufacturer, 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 manufacturer 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.

(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.

<b>Title IV: Pediatric Medical Products - Subtitle A: Best Pharmaceuticals for Children </b>- 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 later 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 exceeds 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 &quot;Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products&quot; take effect on January 1, 2008, unless the the final rule is issued before such date.

<b>Subtitle B: Pediatric Research Improvement</b> - 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.

<b>Subtitle C: Pediatric Medical Devices</b> - 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; and (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 submit to the relevant congressional committees a 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; and (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.
</summary>

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== Status of the Legislation ==

<status>
Latest Major Action: 5/10/2007: Held at the desk.
</status>

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== Points in Favor ==

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== Points Against ==

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