The U.S. Food and Drug Administration (FDA) last month accused Genzyme Corp. and two other drugmakers of failing to satisfy obligations to study previously approved products in children. This is the first example of “public chidings” mandated recently by Congress. In letters send to the companies and posted on its website, the FDA complained about incomplete pediatric clinical trials involving Renvela, a Genzyme kidney drug, and Hectorol, Amedra Pharmaceuticals’ allergic shock medicine Twinject and Cleviprex, the Medicines Co.’s blood pressure treatment.
All the letters, which Congress directed the FDA to post last year in a user-fee law, concerned drugs for which pediatric studies that had been deferred until after a drug’s initial approval were supposed to have been finished years ago. It has been more than seven years ago in the case of the Hectorol drug. That may come as a shock to many of our readers, but I must confess that I wasn’t surprised at all when I learned of the delays.
But interestingly, none of the letters from the FDA made any mention of penalties. Under the user-fee legislation, failure to comply with pediatric study requirements can lead to a drug being deemed “misbranded,” but the failure cannot result in approval being revoked. The FDA did make it clear, however, that the drugmakers were running afoul of their legal duties by not completing the studies. The circumstances surrounding each shortcoming were similar. The companies failed to seek a time extension or neglected to finish a study after the FDA declined to grant an extension. The requirement to study safety and effectiveness in children in certain circumstances was a provision of the Pediatric Research Equity Act of 2003. Perhaps Congress needs to revisit this matter and make the law tougher.
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