FDA Can Post On ClinicalTrials.gov, But Unlikely To Use Authority, Agency Says
This article was originally published in The Pink Sheet Daily
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.
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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.
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.
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.