See generally, In re Vioxx Products Liability Litigation 360 F.Supp.2d 1352 (Jud. Pan.Mult.Lit., 2005); In re Paxil Products Liability Litigation 296 F.Supp.2d 1374 (Jud.Pan.Mult.Lit., 2003).
2.
US General Accounting Office (GAO), Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities, Publication GAO-02-958 (2002), at 1–3, 18.
3.
Prescription Drug User Fee Act of 1992, Pub L No. 102-571, 21 USC §379, 106 Stat 4491 (1992).
4.
WoodcockJ., Drug Safety and the Drug Approval Process, testimony before the Committee on Health, Education, Labor and Pensions, United States Senate, Washington, D.C., March 3, 2005, United States Department Health & Human Services website, at <www.hhs.gov/asl/testify/t050303b.html> (last visited January 5, 2006).
5.
BerndtE. R., PDUFA, Drug Approval Times, Drug Safety Withdrawal Rates, and the Drug Development Process: Empirical Findings, presentation at FDA Public Meeting: Prescription Drug User Fee Act Public Meeting, National Institutes of Health, Bethesda, MD, November 14, 2005, at <http://www.fda.gov/cber/summaries/pdufa111405eb.pdf> (last visited January 5, 2006).
BerndtE. R., “Industry Funding of the FDA: Effects of PDUFA on Approval Times and Withdrawal Rates,”Nature Reviews Drug Discovery4 (2005): 545–554.
9.
ThompsonL., “User Fees for Faster Drug Reviews: Are they Helping or Hurting the Public Health?”FDA Consumer Magazine34, no. 5 (2000): 25–29, at 26.
10.
See Berndt, supra note 8.
11.
CarpenterD. P., “The Political Economy of FDA Drug Review: Processing, Politics, and Lessons for Policy,”Health Affairs23 (2004): 52–63, at 55–56.
12.
FontanarosaP. B., “Postmarketing Surveillance-Lack of Vigilance, Lack of Trust,”JAMA292 (2004): 2647–2650 at 2647.
13.
PearR., “Drug Companies Increase Spending to Lobby Congress and Governments,”New York Times, May 31, 2003, at 33.
14.
BeardsleyS., “Avoiding Another Vioxx,”Scientific American292, no. 2 (2005): 16–17.
15.
See GAO, supra note 2, at 25.
16.
CarpenterD., “Data Watch: Approval Times for New Drugs: Does the Source of Funding for FDA Staff Matter?”Health Affairs (December 17, 2003): W3-618-24, at W3–623.
17.
See Carpenter, supra note 16, at WS-620.
18.
See Carpenter, supra note 16, at WS-623.
19.
KaitinK. I., ed., “Drug Safety Withdrawals in the U.S. Not Linked to Speed of FDA Approval,”Tufts Center for the Study of Drug Development Impact Report7, no. 5 (2005).
20.
See Kaitan, supra note 19.
21.
See Berndt, supra note 5.
22.
LangelS., “Interest Groups Skeptical of FDA's Risk-Based Assessment System,”Washington Drug Letter37, no. 40 (2005).
23.
See Langel, supra note 22.
24.
See Langel, supra note 22.
25.
Report to the Nation: Improving Public Health Through Human Drugs, Center for Drug Evaluation and Research, US Department of Health and Human Services (2003): at 39.