Food and Drug Administration Amendments Act of 2007
Last updated
US law
Food and Drug Administration Amendments Act of 2007
Long title
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Passed the Senate on September 20, 2007(Unanimous Consent) with amendment
House agreed to Senate amendment on September 20, 2007(cleared) with further amendment
Senate agreed to House amendment on September 20, 2007(cleared)
Signed into law by PresidentGeorge W. Bushon September 27, 2007
President of the United StatesGeorge W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices.[1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.[2]
The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items.
Title I: Prescription Drug User Fee Amendments of 2007
Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems and conducting screenings of the Adverse Event Reporting System database and reporting on new safety concerns.
It also reauthorizes the Prescription Drug User Fee Act. The PFUDA was first enacted in 1992 to allow the FDA to collect application fees from pharmaceutical companies when applying for approval for a drug. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007. The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs.[3] The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers.[4]
It requires the FDA, through the authority of 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.
It sets forth special rules for positron emission tomography drugs, including subjecting an applicant in a drug application for a PET drug to one-sixth of the annual prescription drug establishment fee.
It exempts approved drugs or biological products designated for a rare disease (orphan drugs) from product and establishment fees if certain requirements are met, including that the drug is owned/licensed and marketed by a company having gross worldwide revenues that fall below a certain amount.[5]
Title II: Medical Device User Fee Amendments of 2007
Title II is given the short title of "Medical Device User Fee Amendments" (MDUFA). It defines terms relating to fees for medical devices. "30-day notice" is defined as a notice of a supplement to an approved application that is limited to a request to make modifications to manufacturing procedures or methods affecting the safety and effectiveness of the device.
It makes changes to medical device fees, including establishing a fee for a 30-day notice, a request for classification information, and periodic reporting for a class III device.
It extends the authority of accredited people (third parties) to review premarket reports for devices and make recommendations to the FDA regarding the classification of devices.
It requires any establishment in a foreign country engaged in the manufacturing or processing of a drug or device that is imported into the US to annually register with the FDA.[5]
Title III: Pediatric Medical Device Safety and Improvement Act of 2007
Title III 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 available, a description of any pediatric subpopulations that suffer from the disease that the device is intended for, and the number of affected pediatric patients.
It requires the FDA to submit an annual report to congressional committees 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.
It authorizes the FDA to determine that adult data on medical devices may be used to support claims of effectiveness in pediatric populations if the course of the disease and the effects of the device are sufficiently similar in adults and pediatric patients.
It excludes a person granted a humanitarian device exemption from the prohibition against selling the device for an amount that exceeds its research and development, fabrication, and distribution costs if: (1) the device is intended to treat or diagnose a disease or condition that occurs in pediatric patients; (2) the device was not approved for pediatric patients prior to enactment of this Act; (3) the number of devices distributed does not exceed an annual distribution number specified by the Secretary; and (4) the request for exemption is submitted on or before October 1, 2012.[5]
Title IV: Pediatric Research Equity Act of 2007
Title IV 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 FDA a timeline for the completion of pediatric studies. It also sets forth annual reporting requirements for an applicant following the approval of such a deferral.
It requires that an applicant seeking waiver of pediatric assessment submission requirements on the grounds that a pediatric formulation cannot be developed, to submit documentation detailing why a pediatric formulation cannot be developed. It also authorizes the FDA to require submission of a pediatric assessment if the Secretary finds that adequate pediatric labeling could confer a benefit on pediatric patients or the absence of adequate pediatric labeling could pose a significant risk to pediatric patients.[5]
Title V: Best Pharmaceuticals for Children Act of 2007
It 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 change the definition of "pediatric studies" to authorize the Secretary to include preclinical studies, to require the studies to be completed using appropriate formulations for each age group for which such a study is requested, and to prohibit the FDA from extending the period of market exclusivity later than nine months prior to the expiration of the period.
It requires an applicant that does not agree to the request for a pediatric study to submit to the Secretary the reasons such pediatric formulations cannot be developed, and requires an applicant that agrees to the request to provide the Secretary with all post-marketing adverse event reports regarding the drug.
It directs the FDA to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if the pediatric formulation is not introduced onto the market within one year after the determination regarding market exclusivity; (2) utilize the internal review committee to review all written requests for pediatric studies issued; (3) track and make publicly available information on the pediatric studies conducted; (4) order the labeling of a product to include information about the results of the study and a statement that a pediatric study does or does not demonstrate that the drug is safe and effective in pediatric populations; and (5) ensure that all adverse event reports that have been received for a drug are referred to the Office of Pediatric Therapeutics. It prescribes actions for the FDA 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.
It requires the pediatric subcommittee of the Oncologic Drugs Advisory Committee to provide recommendations to the internal review committee that reviews pediatric research requests with respect to the treatment of pediatric cancer.[5]
The Pediatric Trials Network serves as the mechanism by which many studies on off-patent drugs are performed, in keeping with the BPCA objective of ensuring accurate drug labeling for children.
Title VI: Reagan-Udall Foundation
Title VI establishes the Reagan-Udall Foundation for the Food and Drug Administration as a nonprofit corporation to advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety. It 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.
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4) develop a peer review process by which intramural research can be evaluated; (5) identify and solicit intramural research proposals from across the FDA; and (6) develop additional post-marketing safety performance measures.[5]
Title VII: Conflicts of Interest
Title VII places limits on who can serve on an FDA advisory committee. It directs the FDA to implement strategies on effective outreach to potential members of advisory committees and to review the expertise and financial disclosure report of an individual when considering an appointment to an advisory committee. It prohibits any member of an advisory committee from participating with respect to any matter in which the member has a financial interest, unless the member is granted a waiver in order to afford the advisory committee essential expertise. The number of waivers is limited and decreases as a percentage of committee members over several years.[5]
Title VIII: Clinical Trials Databases
Title VIII is in regard to clinicaltrials.gov.[6] It amends the Public Health Service Act to require the FDA, acting through the Director of NIH, to expand the clinical trials registry data bank. It requires the Director to ensure that the data bank is made publicly available through the Internet and requires the FDA to ensure that the data bank includes links to results information for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug or device involved is approved or cleared.[5]
Title IX: Enhanced Authorities Regarding Postmarket Safety of Drugs
Title IX prohibits a "responsible person" from introducing into interstate commerce a new drug, if the person is in violation of a requirement related to post-approval clinical trials or labeling changes.
It authorizes the FDA to require a responsible person for a drug to conduct a post-approval study or clinical trial of the drug to assess a known serious risk or signals of a serious risk or to identify an unexpected serious risk, to require a postapproval study or clinical trial for an already approved drug only if the Secretary becomes aware of new safety information, and to issue an order directing a responsible person or holder of an approved application to make a labeling change to address new safety information.
It prohibits a person from introducing into interstate commerce a new drug or biological product for which a risk evaluation and mitigation strategy is required if the person fails to maintain compliance with the requirements of such strategy.
It requires a proposed risk evaluation and management strategy to include a timetable for assessment of the strategy and allows the FDA to require such a strategy to include additional elements, including distribution to each patient of a Medication Guide and a patient package insert, a communication plan to health care providers, and assurances of safe use.
It authorizes the FDA to require the submission of any TV advertisement for a drug for review before it can be broadcast, to make recommendations with respect to information included in the label of the drug or on statements for inclusion in advertisements but not require changes in such advertisements, and to require inclusion in advertisements of certain disclosures about a serious risk listed in the labeling of the drug.
It requires the FDA to issue special guidance for clinical trials of antibiotics.
It prohibits interstate commerce of any food that has an approved drug, licensed biological product, or certain other drugs or biological products added, unless the drug or biological product was marketed in food prior to approval, licensure, or clinical investigation, the FDA has approved the use of such drug or biological product in the food, or the use of the drug or the biological product is to enhance the safety or preservation of the food and not intended to have biological or therapeutic effects and the use is in conformity with specified regulations.
It requires the FDA to develop standards to secure the drug supply chain against counterfeit, diverted, substandard, adulterated, misbranded, or expired drugs, to prioritize and develop standards for the identification and validation of prescription drugs, to develop a standardized numerical identifier for prescription drugs, and to expand resources and facilities for securing the drug supply chain.
It requires the Advisory Committee on Risk Communication to regularly perform a comprehensive review of the types of risk information provided on the website and to recommend ways for the FDA to work with outside entities to help facilitate communication of risk.
It requires that certain information related to a new drug application be published on the FDA's website, including documents related to the review of an application and a summary of conclusions from all reviewing disciplines about the drug. It stipulates that a scientific review of an application is considered the work of the reviewer and prohibits the altering of such work by management or the reviewer once it is final.
It directs the FDA to publish and update quarterly a complete list of all authorized generic drugs on the FDA's website.[5]
Title X: Food Safety
Title X requires the FDA to work with companies, professional associations, and other organizations during an ongoing recall of food regulated by the FDA to collect and aggregate information, to use existing networks to enhance the quality and speed of public communication, and to post information regarding recalled food on the FDA's website in a single location.
It requires the FDA to work with states to assist in improving the safety of food. It requires a responsible person who determines that an article of food is a reportable food to submit a report to the FDA within 24 hours and to investigate the cause of the adulteration if the adulteration may have originated with the responsible person. It requires the FDA to immediately notify the Secretary of Homeland Security if the FDA believes food reported to the registry may have been deliberately adulterated.
It requires the FDA to produce a report on any environmental risks associated with genetically engineered seafood products and sets forth reporting requirements with respect to food products regulated by the FDA.[5]
Title XI: Other Provisions
Title XI requires the FDA to identify and periodically update clinically susceptible concentrations (specific values that characterize bacteria as clinically susceptible, intermediate, or resistant to the drug tested). It directs the FDA to convene a public meeting regarding which infectious diseases potentially qualify for available grants and contracts under the Orphan Drug Act or other incentives for development, and amends the Orphan Drug Act to reauthorize appropriations for grants and contracts to defray the costs of testing for the development of drugs, medical devices, and medical foods for rare diseases.
It allows an applicant for a non-racemic drug containing as an active ingredient a single enantiomer that is contained in a racemic drug approved in another application to elect to have the single enantiomer considered the same active ingredient as that contained in the approved racemic drug under certain circumstances.
It requires the HHS Secretary to enter into a contract with the Institute of Medicine to conduct a study to assess the overall safety and quality of genetic tests and prepare a report that includes recommendations to improve federal oversight and regulation of genetic tests.[5]
Priority review voucher program
Title XI also created the priority review voucher program. This requires the FDA to award a transferable, priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such application and establish a priority review user fee program. In this Act, only tropical diseases were covered under this program to incentivize the development of neglected tropical diseases. In 2012, this was expanded to include rare pediatric conditions. As of 2017, 13 priority review vouchers have been awarded.
The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
The United States Federal Food, Drug, and Cosmetic Act, is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The Food and Drug Administration (FDA)'s New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
An investigational device exemption (IDE) allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is a particular [medical] condition while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.
A biosimilar is a biologic medical product highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment.
A glossary of terms used in clinical research.
The following outline is provided as an overview of and topical guide to clinical research:
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.
This article is about the history of the United States Food and Drug Administration.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.
Janet Woodcock is an American doctor of medicine and the current director of the Center for Drug Evaluation and Research (CDER), a department of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there including terms as the Director of CDER from 1994-2004 and 2007–present. She has been described by the National Consumers League as "a passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA."
↑ Research, Office of the Commissioner,Center for Biologics Evaluation and Research,Center for Drug Evaluation and. "Prescription Drug User Fee Act (PDUFA)". www.fda.gov.
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