FDA responds to Institute of Medicine drug safety recommendations - In part

JAMA

Volumn 297, Issue 17, 2007, Pages 1917-1920

  Psaty, Bruce M ^a   Charo, R Alta ^b  

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ROFECOXIB;

DRUG APPROVAL; DRUG EFFECT; DRUG EFFICACY; DRUG IDENTIFICATION; DRUG INDUSTRY; DRUG MARKETING; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HEALTH CARE; NOTE; ORGANIZATION; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; ARTICLE; DRUG SURVEILLANCE PROGRAM; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG APPROVAL; INSTITUTE OF MEDICINE (U.S.); UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34247871340     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.297.17.1917     Document Type: Note

References (25)

1. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance: lack of vigilance, lack of trust [editorial]. JAMA. 2004;292:2647-2650.
2. Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Baciu A, Stratton K, Burke SP, eds. Washington, DC: National Academies Press; 2007.
3. Food and Drug Administration. The future of drug safety: promoting and protecting the health of the public: FDA's response to the Institute of Medicine's 2006 report. US Dept of Health and Human Services, January 2007. http://www.fda.gov/oc/reports/iom013007.html. Accessed January 30, 2007.
4. Grassley seeks permanent FDA commissioner: senator says nominee should be able to focus 100 percent on FDA [press release]. September 26, 2005. http://www.finance.senate.gov/press/Gpress/2005/prg092605a.pdf. Accessed April 4, 2007.
5. Gale EA. Lessons from the glitazones: a story of drug development. Lancet. 2001;357:1870-1875.
6. Tufts Center for the Study of Drug Development. FDA requested postmarketing studies in 73% of recent new drug approvals. Impact Report. 2004;6(4):1-4.
7. Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability. Fed Regist. 2005;70:8379-8381.
8. Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies. Fed Regist. 2006;71:10978-10979.
9. Food and Drug Administration. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability. Fed Regist. 2007;72:5069-5070.
10. Office of Inspector General, Department of Health and Human Services. FDA's Monitoring of Postmarketing Study Commitments. Washington, DC: Dept of Health and Human Services; June 2006. OEI-01-04-00390. http://oig.hhs.gov/ oei/reports/oei-01-04-00390.pdf.
11. Office of Inspector General, Department of Health and Human Services. FDA's Review Process for New Drug Applications: A Management Review. Washington, DC: Dept of Health and Human Services; March 2003. OEI-01-01-00590. http://oig.hhs.gov/oei/reports/oei-01-01-00590.pdf.
12. US Government Accountability Office. Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process. GAO Report to Congressional Requestors. March 2006. GAO-06-402. http://www.gao.gov/new.items/ d06402.pdf.
13. US Dept of Health and Human Services. Food and Drug Administation. Draft guidance for the public, FDA advisory committtee members, and FDA staff on procedures for determining conflict of interest and eligibility in FDA advisory committees. http://www.fda.gov/oc/advisory/waiver/coiguidedft.html. March 2007. Accessed March 23, 2007.
14. Union of Concerned Scientists. Scientific integrity: summary of the FDA scientist survey. http://www.ucsusa.org/scientific_integrity/interference/fda- scientists-survery-summary.html. Accessed July 22, 2006.
15. Ross DB. Testimony before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, February 13, 2007. http://energycommerce.house.gov/cmte_mtgs/110-oi_hrg.021307.FDA_drug_supply. shtml. Accessed February 14, 2007.
16. Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet. 2004;363:1341-1345.
17. Lisse JR, Perlman M, Johansson G, et al. Gastrointestinal tolerability and effectiveness of rofecoxib versus naproxen in the treatment of osteoarthritis: a randomized, controlled trial. Ann Intern Med. 2003;139:539-546.
18. Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med. 2000;343:1520-8. N Engl J Med. 2005;353:2813-2814.
19. Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed [published online ahead of print February 22, 2006]. N Engl J Med. 2006;354:1193.
20. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. JAMA. 2004;292:2622-2631.
21. Psaty BM, Furberg CD. COX-2 inhibitors: lessons in drug safety. N Engl J Med. 2005;352:1133-1135.
22. Psaty BM, Weiss NS. NSAID trials and the choice of comparators: questions of public health importance. N Engl J Med. 2007;356:328-330.
23. Psaty BM, Weiss NS, Furberg CD. Recent trials in hypertension: compelling science or commercial speech? JAMA. 2006;295:1704-1706.
24. Graham J, James F. Flaws in drug agency put consumer at risk. Chicago Tribune. February 20, 2005:C1.
25. Food and Drug Administration. Prescription Drug User Fee Act; public meeting [docket No. 2007N-0005]. Fed Regist. 2007;72:1743-1753.