Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
Currently Skimming:
Summary
Summary
Pages 1-8
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs)
|
From page 2... ...
The symposium's presentations and discussions were in most cases framed by selected recommendations from the report, and are summarized here in seven key areas: · addressing the FDA's resource challenges; · strengthening the scientific base of the agency; · integrating pre- and postmarket review; · enhancing postmarket safety monitoring; · conducting confirmatory drug safety and efficacy studies; · enhancing the value of clinical trial registration; and · enhancing the FDA's postmarket regulation and enforcement. The presentations and discussions included the types and magnitude of resources required in these areas.
|
From page 3... ...
Alta Charo, University of WisconsinMadison, and member of the IOM Drug Safety Committee, stressed that, although the FDA regulates an extraordinary proportion of the products on the American market, it operates with a budget that is not commensurate with this broad regulatory authority. She noted that the committee responsible for the IOM report highlighted its consensus conclusion that more public funding is needed for the FDA, specifically more general appropriations.
|
From page 4... ...
A primary goal of the FDA's Critical Path Initiative is to increase the efficiency of the drug development process by building safety into products throughout their development life cycle. Panelists at the symposium described a broad spectrum of urgent safety science research needs and indicated that because the FDA is limited in its ability to conduct such research, one of its primary goals must be to collaborate with industry and academia to form publicprivate partnerships.
|
From page 5... ...
Additionally, panelists considered ways of developing better methods for data capture through sharing of best practices, one of many potential collaborative efforts discussed throughout the day. ENHANCING POSTMARKET SAFETY MONITORING A conclusion of the IOM report was that the FDA's current postmarket surveillance system is neither as comprehensive nor as systematic as it needs to be to detect, interpret, and analyze safety signals effectively and efficiently.
|
From page 7... ...
drug safety system. Whatever steps are taken to improve drug safety, it is critical that those actions not restrict access to appropriate medications or otherwise interfere with patients' rights to make informed decisions about drug use with their doctors, and that the risks and benefits of drugs be carefully weighed "in full public view." With regard to the future of drug safety regulation, it is essential to take immediate steps to capitalize on the significant progress made since the release of the IOM report, especially in light of the opportunity represented by the anticipated reauthorization of PDUFA.
|
From page 8... ...
public–private collaboration so stakeholders can work together to accomplish shared goals; and (5) the agency's regulatory authority.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.