ParadiseJ., “Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology,”Journal of Law, Medicine & Ethics37, no. 4 (2009): 546–586.
2.
Many of the expansions of the FDA regulatory authority are quite detailed and specific in terms of scope of authority, tools available for implementation, and procedures that must be followed in developing regulations to implement the statutes. The FDA has very limited discretion in implementing these directives. For an illustration of these constraints relevant to another agency in the Department of Health and Human Services (DHHS), the Centers for Medicare and Medicaid Services (CMS), see FooteS. B., “Why Medicare Cannot Promulgate a National Coverage Rule: A Case of Regula Mortis,”Journal of Health Politics, Policy and Law27, no. 5 (2002): 707–744.
3.
Remarks of former Commissioner Jane S. Henney, at the Medical Technology Leadership Forum, Indianapolis, IN, December 8, 2008, cited in “FDA in the 21st Century: Issues and their Impact on Medical Technology,” at 3, available at <www.mtlf.org/docs/ForumReport-Inpls-Finals.pdf> (last visited October 30, 2009).
4.
See CarpenterD. P., “Groups, the Media and Agency Waiting Costs: Political Economy of FDA Drug Approval,”American Journal of Political Science46, no. 3 (2002): 490–505.
5.
See EgilmanD. S.PreslerA. H.ValentinC. S., “Avoiding Regulatory Capture of the Food and Drug Administration,”Archives of Internal Medicine167, no. 7 (2007): 732–733.
6.
FooteS. B.BerlinR. J., “Can Regulation Be as Innovative as Science and Technology? The FDA's Regulation of Combination Products,”Minnesota Journal of Law, Science & Technology6, no. 2 (2005): 619–644.
7.
See id., at 644.
8.
Prescription drug user fees were first enacted in 1992 and medical device user fees followed in 2002. Adjustments to the fees have occurred in reauthorization measures. See Prescription Drug User Fee Act of 1992 (PDUFA), Pub. L. No. 102–571, 106 Stat. 4491 (1992); Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Pub. L. No 107–250; 116 Stat. 1588 (2002). Actual use of these fees has been controversial.
