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Biologicals Prone to Regulatory Actions

First to be approved in a subgroup at higher risk for regulatory action

TUESDAY, Oct. 21 (HealthDay News) -- Health care providers should be aware of the potential risks of biological medicinal products, especially those that are the first to be approved in a subgroup, according to research published in the Oct. 22/29 issue of the Journal of the American Medical Association.

Thijs J. Giezen, of Utrecht Institute for Pharmaceutical Sciences in Utrecht, the Netherlands, and colleagues examined safety-related regulatory actions for 174 biologicals approved in the United States or European Union between 1995 and mid-2007. These included alerts to health professionals, post-approval black box warnings and market withdrawals.

During this period, 41 biologicals were the subject of 82 regulatory actions, including 46 "dear healthcare professional" letters, 19 black box warnings and no withdrawals, the researchers report. The probability of a first safety-related regulatory action was 14 percent three years after approval and 29 percent 10 years after approval, the investigators found. The first biologicals to be approved in their chemical, pharmacological or therapeutic subgroup had a higher risk for such a regulatory action (hazard ratio, 3.7), the study authors note.

"Given the current imperfect process for approval and the flawed post-marketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications," write the authors of an accompanying editorial. Patients "who are injured by defective medical devices or by pharmaceutical products with inadequate warnings of potential harms may have to resort to legal action as recourse for their injuries."

Several researchers disclosed personal or employer-related relationships with pharmaceutical companies.

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