Healthy Skepticism Library item: 10303

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: news

Taylor L.
Postmarketing studies contribute little, study finds
Pharma Times 2007 May 31
http://www.pharmatimes.com/WorldNews/Articles/10968-postmarketing-Tufts.aspx?src=PharmaTimes

Full text:

Drug developers have increased the number of postmarketing studies which they conduct on newly-approved medicines over the past six years, but sponsors believe this work has contributed little to their understanding of the new products, according to a new survey carried out by the Tufts Center for the Study of Drug Development (Tufts CSDD).

Sixtyeight percent of clinical study sponsors and 79% of non-clinical study sponsors told the Tufts researchers that postmarketing study results have contributed either marginally or not at all to their understanding of the safety, efficacy or quality of their new products, although 32% felt the studies had “significantly or very significantly” increased their understanding.

Considerable progress has been made since the US Food and Drug Administration (FDA) regulation requiring sponsors to provide annual reports on the status of such studies took effect in 2001, but a major challenge faced by drug sponsors is completing the studies on time, according to Tufts CSDD associate director Christopher-Paul Milne. While over half of all postmarketing studies for which final study reports were submitted were finished by their projected completion date, 45% were delayed due to enrollment problems, technical difficulties, additional FDA requirements or sponsors expanding the scope of their own studies, the survey found.

Other findings included that:

- clinical studies took an average of 10 months longer to complete and cost nearly nine times as much as non-clinical studies;

- postmarketing studies are typically the responsibility of applicable R&D departments (clinical development, preclinical, toxicology, laboratory, etc) and not marketing departments, as some
critics of the Prescription Drug User Fee Act (PDUFA) have claimed; and

- during 1998-2005, drug sponsors spent an average of $5.3 million per clinical postmarketing study, compared to $610,000 for each non-clinical study.