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Healthy Skepticism Library item: 7538

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Kaitin KI, Cairns C.
The new drug approvals of 1999, 2000, and 2001: Drug development trends a decade after passage of the Prescription Drug User Fee Act of 1992
Drug Information Journal 2003; 34:(7):357-371


Abstract:

This report is the sixth in a triennial series by the Tufts Center for the Study of Drug Development examining various aspects of recent new drug approvals in the United States. In 1999, 2000, and 2001 the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved 86 new drugs, 82 of which met the Tufts Center for the Study of Drug Development’s definition of a new chemical entity (NCE). Of the 82, 34 (41 ) received priority review, while 48 (59) had standard review. The mean length of the clinical phase (Investigational New Drug Application [IND] filing to New Drug Application [NDA] submission) for the 82 NCEs was 5.5 years, and the mean approval phase (NDA submission to approval) was 1.4 years. Whereas the clinical phase represents a 14 % decrease from that value for the previous three-year period, the approval phase remained unchanged. The mean approval phase for priority NCEs (0.9 years) was half that for standard NCEs (L 8 years). Of the 75 NCEs for which foreign marketing data were available, 51 % were first approved for marketing in the United States, while 27% were available in foreign markets one or more years prior to United States approval, with a mean of 6.5 years of prior foreign marketing. The percentage of products first approved in the United States represents a continuation of a trend since passage of the Prescription Drug User Fee Act of 1992 of drug sponsors seeking marketing approval in the United States prior to approval in other markets.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.