President of the United States George 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.
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.
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.
The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs.
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.
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 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 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 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.
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 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 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.
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.