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FDA's post-approval studies continue to suffer delays and setbacks

Nature Medicine volume 20, pages 1224–1225 (2014)Cite this article

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In 1998, the US Food and Drug Administration (FDA) approved an antimicrobial solution called Sulfamylon to stave off infections in people with severe burns. Because the drug, manufactured by Mylan, a company based in Canonsburg, Pennsylvania, qualified for accelerated approval, the agency required the company to conduct a post-approval trial to confirm the efficacy of the medicine, which also goes by the generic name mafenide acetate. But 16 years later, that trial has yet to be completed. As of July—the most recent date for which information was available as Nature Medicine went to press—the company hadn't even finished enrollment, according to an FDA database. Mylan did not respond to Nature Medicine's requests for comment, but the database describes the study, which was due in 2010, as “delayed.”

The Sulfamylon trial is just one of the approximately 150 required post-approval drug studies that are incomplete and past their original due date. In some cases, the manufacturers have valid reasons for the delays: enrollment is lagging, or they're working to revise the study protocol. In other cases, there is no publicly available explanation for the delay, or the company has refused to do what was required of them. And some of the same problems that plague post-market drug studies appear to extend to post-approval studies of medical devices. An analysis published in late September found that 18% of the 223 post-approval studies ordered between 2005 and 2011 for medical devices had made “inadequate progress” and that, for a third of these, it was impossible to determine the reason for the delay1.

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References

  1. Reynolds, I.S. et al. J. Am. Med. Assoc. Intern. Med. doi:https://doig.org/10.1001/jamainternmed.2014.4194 (29 September 2014).

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  1. Cassandra Willyard
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Willyard, C. FDA's post-approval studies continue to suffer delays and setbacks. Nat Med 20, 1224–1225 (2014). https://doi.org/10.1038/nm1114-1224

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