The Prescription Drug User Fee Act of 1992: A 5-year experiment for industry and the FDA

PharmacoEconomics

Volumn 9, Issue 2, 1996, Pages 121-133

  Shulman, Sheila R ^a   Kaitin, Kenneth I ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; COST; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG LEGISLATION; DRUG USE; FEE; FOOD AND DRUG ADMINISTRATION; PRESCRIPTION; PRIORITY JOURNAL; REVIEW;

EID: 0030033574     PISSN: 11707690     EISSN: None     Source Type: Journal    
DOI: 10.2165/00019053-199609020-00004     Document Type: Review

References (46)

1. Pub Law 102-571 (1992 Oct 29); 21 USC 379; 106 Stat 4491
2. Food and Drug Administration. Establishment of prescription drug user fee revenues and rates for Fiscal Year 1994. Fed Reg 1993 Dec 13; 58: 65184
3. Food and Drug Administration. Establishment of prescription drug user fee revenues and rates for Fiscal Year 1995. Fed Reg 1994 Dec 9; 59: 63808
4. Food and Drug Administration. Establishment of prescription drug user fee revenues and rates for Fiscal Year 1996. Fed Reg 1995 Dec 1; 60: 61702
5. Veverka MJ. FDA user fee update 1994. Presented at Drug Information Association 30th Annual Meeting: 1994 Jun 7; Washington, DC
6. British user fee system benefits drug agency and public. FDC Rep Pink Sheet 1993 Jan 25: T&G 10-1
7. Council regulation on fees payable to the European Medicines Evaluation Agency. COM (95); 1995 Jan
8. Drugs Directorate Cost Recovery Fact Book. Ottawa: Pharmaceutical Manufacturers Association of Canada, 1995
9. Fees not charged for processing applications for new drugs [B-16403(2)]. Washington, DC: US General Accounting Office, 1971 Nov 4
10. Independent Offices Appropriation Act of 1952. Title V. Pub Law 455 (1952 Jul 5); 31 USC 9701
11. Food and Drug Administration. New drug and antibiotic application review: proposed user charge. Fed Reg 1985 Aug 8; 50: 31726
12. Henkel J. User fees to fund faster reviews. FDA Consumer 1993 Oct; 27 (8): 19-21
13. US Senate, Congress. Hearing of the Committee on Labor and Human Resources on user fees for the Food and Drug Administration. 102nd Congress, 2nd Session. Statement of Gerald J. Mossinghoff, President, Pharmaceutical Manufacturers Association, 1992 Sep 22: 52
14. Advisory Committee on the Food and Drug Administration (The Edwards Committee). Final report of the advisory committee on the Food and Drug Administration [appendices A-9-10]. Washington, DC: Department of Health and Human Services, 1991 May
15. US Senate, Congress. Hearing of the Committee on Labor and Human Resources on User Fees for the Food and Drug Administration. 102nd Congress. 2nd Session. Statement of Irwin Lerner, President and CEO, Hoffmann-La Roche Inc., 1992 Sep 22: 44
16. Advisory Committee on the Food and Drug Administration (The Edwards Committee). Final report of the advisory committee on the Food and Drug Administration. Washington, DC: Department of Health and Human Services, 1991 May: 47
17. Berkowitz K. History and rationale for industry support of user fee program. Presented at a Joint PMA, IBA, FDA Workshop. User fees: FDA/industry partnership for achieving performance goals: the impact on drug development. Washington, DC: Pharmaceutical Manufacturers Association, 1993 Feb 2
18. Food and Drug Administration (FDA). Draft interim guidance document for waivers of and reductions in user fees. Rockville (MD): FDA, 1993 Jul
19. Second Annual Financial Report: Prescription Drug User Fee Act of 1992: fiscal year 1994 report to Congress. Rockville (MD): Food and Drug Administration, 1994 Dec
20. US Senate, Congress. Hearing of the Committee on Labor and Human Resources on User Fees for the Food and Drug Administration. 102nd Congress, 2nd Session. Statement of Mark B. Skaletsky, Chairman, Enzytech Inc., 1992 Sep 22: 55
21. Food and Drug Administration (FDA). Interim guidance: applicability of user fees to: (1) applications withdrawn before filing decision, or (2) applications the Agency has refused to file and that are resubmitted or filed over protest. Rockville (MD): FDA, 1993 Jul
22. Food and Drug Administration (FDA). Interim guidance: separate marketing applications and clinical data for purposes of assessing user fees under the Prescription Drug User Fee Act of 1992. Rockville (MD): FDA, 1993 Jul
23. O'Shea S. User fee update relating to orphan drug research. Presented at Orphan Drug Development - Update and Issues. 1994 Nov 3: Washington, DC. Washington, DC: Drug Information Association, 1994
24. US Senate, Congress. Hearing of the Committee on Labor and Human Resources on User Fees for the Food and Drug Administration. 102nd Congress, 2nd Session. Statement of Gerald J. Mossinghoff, President, Pharmaceutical Manufacturers Association, 1992 Sep 22: 53 and Mark B. Skaletsky, Chairman, Enzytech, Inc.: 57
25. Shulman SR, Lasagna L, editors. FDA user fees in an era of proposed FDA reform: proceedings from a forum sponsored by the Tufts Center for the Study of Drug Development, Tufts University: Cambridge (MA): 1995 May 18
26. Third Annual Performance Report: Prescription Drug User Fee Act of 1992. Fiscal Year 1995 Report to Congress. Rockville (MD): Food and Drug Administration, 1995 Dec
27. US General Accounting Office. FDA user fees: current measures not sufficient for evaluating effect on public health (GAO/ PEMD-94-26). Washington, DC: US General Accounting Office, 1994 Jul
28. Veverka MJ. Prescription Drug User Fee Act of 1992: status of implementation. Presented at Pharmaceutical Manufacturers Association (PMA) Regulatory Affairs Committee Annual Meeting. 1993 Feb 4: Washington, DC. Washington, DC: PMA, 1993
29. Devine R. PLA update: an overview of the current approval process. Presented at Biologics Update 1994. sponsored by the Food and Drug Law Institute: 1994 Jul 25: Washington, DC. Washington, DC: Food and Drug Law Institute, 1994
30. CBER to use action letters for the first time. Biologics and Biotech Regulatory Report Section of US Regulatory Reporter 1993 May; 9 (11): 4
31. Filing an application and an abbreviated antibiotic application and receiving an abbreviated new drug application. 21 CFR 314,101
32. Application for establishment and product licenses: procedures for filing. 21 CFR 601.2
33. Drug review process 'reengineering' unlikely under user fees. US Regulatory Reporter 1993 May; 9 (11): 7-8
34. Center For Drug Evaluation and Research (CDER). New drug evaluation guidance document: refusal to file. 1993 Jul 12. Rockville (MD): Food and Drug Administration, 1993
35. Center For Biologies Evaluation and Research (CBER). Refusal to file (RTF) guidance for product license applications (PLAs) and establishment license applications (ELAs). 1993 Jul 12. Rockville (MD): Food and Drug Administration, 1993
36. New drug applications: refusal to file: change in schedule of meetings of the Review Committee. Fed Reg 1994 Sep 21; 59: 48440
37. Beatrice M. The product and establishment application review process - FDA's policy. Presented at The Food and Drug Law Institute's 38th Annual Educational Conference: 1994 Dec 14; Washington, DC. Washington, DC: Food and Drug Law Institute, 1994
38. Lumpkin M, Beatrice M. FDA user fee update 1994. Presented at The Drug Information Association 30th Annual Meeting: 1994 Jun 7; Washington, DC. Washington, DC: Drug Information Association, 1994
39. FDA 'soft' hiring freeze allows one hire for every three departures. FDC Rep Pink Sheet 1994 Jun 20; 56 (25): T&GI
40. FDA salaries and expenses shortfall of $44 mil. FDC Rep Pink Sheet 1994 Sep 26; 56 (39): T&GI
41. Veverka MJ. User fee requirements: current issues. User fees for drugs and devices. Presented at The Regulatory Affairs Professionals Society meeting: Washington, DC: 1994 Sep 19. The Regulatory Affairs Professionals Society, 1994 Sep
42. Window for change. BioCentury 1994 Dec 5; 2 (80): A6
43. GOP takes aim at FDA, seeking to ease way for approval of new drugs, medical products. Wall Street J 1994 Dec 12: CCXXIV (114): A16
44. Second Annual Performance Report: Prescription Drug User Fee Act of 1992. Fiscal Year 1994 Report to Congress. Rockville (MD): Food and Drug Administration, 1994 Dec
45. DiMasi J, Hansen R, Grabowski H, et al. Cost of innovation in the pharmaceutical industry. J Health Econ 1991; 10: 107-42
46. Prescription Drug User Fee Act of 1992. Pub Law 102-571, Section 102 (1992 Oct 29)