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Most postmarketing trials on-track, FDA says

An FDA report on postmarketing commitments shows that most studies and clinical trials are being completed by product sponsors in a timely fashion

The US Food and Drug Administration's (FDA) second annual report on postmarketing commitments shows that most of the studies and clinical trials are being completed by the product sponsors in a timely fashion.

The survey, which was based on more than 1,551 postmarketing studies and clinical trials, showed that 40 per cent of the postmarketing commitments had been fulfilled or released by the FDA, and that, of the remaining 60 per cent, most were in progress and on schedule.

The status of 591 postmarketing requirements and commitments changed during the 2009 review period, with 46 per cent of them becoming designated as fulfilled, the agency said. That figure "reflects a significant effort by FDA staff to complete reviews of the large number of submitted final reports identified during the first annual review," the agency stressed.

The remainder of the status changes reflected study/trial initiation and completion, final report submission or missed milestone dates. However, the FDA pointed out that only 17 per cent of the backlogged studies were delayed and that just 7 per cent of those on schedule after the first annual review became delayed during the second review.

The latest review was conducted for the FDA by Booz Allen Hamilton. It examined the backlog of industry postmarketing studies and clinical trials for FDA-approved drugs and biologics, meaning all those postmarketing requirements and postmarketing commitments open when the Food and Drug Administration Amendments Act was enacted on September 27, 2007. That legislation requires the FDA to report on the backlog every year.

In a study released late last year by the Government Accountability Office, the FDA was criticised for not keeping track of postmarketing commitments and failing to enforce the requirements sufficiently. That report, which focused on post-marketing commitments for drugs approved based on surrogate endpoints under the accelerated approval programme, recommended that the FDA make it clear to drug companies the conditions under which drugs would be withdrawn from the market if sponsors failed to meet their post-marketing commitments.

The FDA disagreed with the need for such clarification, but shortly after the release of the report, the FDA proposed pulling Shire's hypotension drug ProAmatine from the market because the company had failed to meet its commitments for post-marketing studies, marking the first time that the agency had ever made such a threat. ProAmatine had been prominently featured in the GAO report as an illustration of the agency's lax approach to enforcing the requirements.

10th November 2010

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