Food and Drug Administration Modernization Act of 1997
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The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products by the FDA. It was signed by Bill Clinton on 21 November 1997,[1] and was fully enacted by 1 April 1999, [2] putting into law reforms begun under the National Partnership for Reinventing Government. One result of the passing of the act was a reduction in the time for the approval of new pharmaceutical drugs.[3]
Provisions
- Called for setting up a public clinical trial registry, leading to the launch of ClinicalTrials.gov.[4]
- Required the FDA to specify which drugs should be required to carry pediatric labeling.[2]
- Allowed the FDA to extend manufacturers' exclusivity rights by 6 months,[2] providing the manufacturers agree to test the therapy on children.[5]
- Removed restrictions on dissemination of off-label uses of pharmaceutical drugs to medical professionals, insurers and government agencies, but not to consumers. This provision was opposed by the FDA, who considered off-label use to be illegal.[2][5]
- Permitted drug approval based on a single controlled clinical trial and confirmatory evidence.[6][5]
- Creation of a "fast track" to give approval to drugs based on surrogate end points,[6] with post-approval studies and the prior approval of marketing material by the FDA.[5]
- Assess the risk of all mercury-containing food and drugs, which lead to the removal of thimerosal from vaccines.[7]
- Renewed the Prescription Drug User Fee Act for five years.[8]
- Called on the FDA to consult with the National Institutes of Health and industry to include more women and minorities in clinical trials.[5]
- Required FDA reviewers to meet with industry sponsors, if requested, before clinical trials begin.[5]
- Relaxed medical device regulations.[5]
- Instructed the FDA to make efforts to harmonize their regulations with international standards.[5]
- Restricted the advertising of compounded drugs, i.e. mixtures made up by pharmacists. This provision was overturned by the US Supreme Court in 2002 on grounds of freedom of speech.[9]
See also
References
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- ↑ Clinton, William J. (21 November 1997). "Statement on Signing the Food and Drug Administration Modernization Act of 1997". The American Presidency Project. John T. Woolley & Gerhard Peters, University of California, Santa Barbara. Retrieved 2009-07-27.
- ↑ 2.0 2.1 2.2 2.3 Buck, Marcia L. (12 January 2000). "The FDA Modernization Act of 1997: Impact on Pediatric Medicine". Pediatric Pharmacotherapy. Medscape. 6 (12).
- ↑ Lua error in package.lua at line 80: module 'Module:Citation/CS1/Suggestions' not found.
- ↑ Fitzgerald, Mary (28 July 2004). "Advocate for Access to Medical Data". Washington Post. Retrieved 2009-07-27.
- ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 Merrill, Richard A. (1999). "Modernizing the FDA: an incremental revolution" (PDF). Health Affairs. Project HOPE. 18 (2): 96–111. doi:10.1377/hlthaff.18.2.96. ISSN 0278-2715. PMID 10091437.
- ↑ 6.0 6.1 Morris, L. (1998). "FDA Modernization Act: implications for oncology". Oncology. 12 (11A): 139–41. PMID 10028506.
- ↑ Centers for Disease Control and Prevention (CDC) (1999). "Notice to Readers: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service". MMWR. CDC. 48 (26): 563–5. PMID 10418806.
- ↑ James, J.S. (1997). "FDA reform signed into law". AIDS Treat News (284): 6–7.
- ↑ Greenhouse, Linda (30 April 2002). "Citing Free Speech, Justices Lift a Ban on Advertising Mixed-to-Order Drugs". New York Times. Retrieved 2009-07-27.
