Why are drug development programs growing in size and cost? A view from industry

Food and Drug Law Journal

Volumn 52, Issue 2, 1997, Pages 151-154

  Niblack, John F ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

CLINICAL TRIAL; CONFERENCE PAPER; COST; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG LABELING; DRUG MANUFACTURE; DRUG SAFETY; LAW; PUBLICATION;

DRUG APPROVAL; DRUG INDUSTRY; FORECASTING; HUMANS; TIME FACTORS; UNITED STATES;

EID: 0030987829     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (8)

1. See J.A. DiMasi, New Drug Development: Cost, Risk and Complexity, 29 DRUG INFO. J. (May 1995).
2. The International Congress on Harmonization is an effort by regulators and industry from Europe, Japan, and the United States to harmonize requirements for clinical trials worldwide, in order to minimize duplicative research and decrease the time required for approval of safe and effective drugs.
3. For example, some would advocate basing approval of antihypertensive drugs on reductions in the incidence of strokes and heart attacks, not on the drugs' ability to lower blood pressure.
4. Regulations for Distribution of New Information, 61 Fed. Reg. 52,800, 52,802 (Oct 8, 1996).
5. Standards for Regulatory Approval of New Uses, 21 C.F.R. § 314.70 (1996).
6. Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat 1585 (codified in scattered sections of 15 U.S.C., 21 U.S.C., 28 U.S.C., 35 U.S.C. (1994)).
7. See A. Southworth, Generic Pharmaceuticals, FINANCIAL TIMES & HEALTH CARE PUB. MNGMT. REP. Fig. 4-3, at 43 (1996).
8. "Consolidated buying" refers to purchases by pharmacy benefit managers in large HMOs servicing very large provider networks.