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FDA Can Post On, But Unlikely To Use Authority, Agency Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Lack of funding and lack of an enforcement mechanism prevent the agency from taking a more active role in ensuring industry compliance with posting requirements. Sens. Johnson and Dodd appear willing to give FDA more enforcement authority.

You may also be interested in... Compliance Will Improve With Time, PhRMA Suggests

Early stats on industry's posting rate should not be seen as evidence of a "widespread breakdown" in the system, PhRMA declares in a letter to Rep. Waxman. PhRMA believes it can reach full compliance – but suggested it may need several years to do it. Rep. Waxman Wants PhRMA To Describe Steps To Improve Compliance

Waxman takes issue with PhRMA’s failure to appear at a recent House hearing to discuss FDA’s clinical trial registry. He asks the association to submit documents it has sent to member companies regarding compliance with the submission requirement. Noncompliance By Industry Remains An FDA Concern

Despite “concerted” communications efforts by FDA, only 47% of clinical trials sponsored by industry are listed on registry website. Oncology Division Director Pazdur tells a House hearing that industry reluctance confuses the agency, which acknowledges “limited” enforcement capabilities.





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