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Executive Briefing Series (formerly The Food & Drug Letter)
April 20, 2012 | Full Issue in PDF Format
FDA-mandated postmarket studies, authorized by the 2007 FDA Amendments Act (FDAAA), can require complex designs, large patient populations (possibly 500,000 patients per arm) and exacting endpoints. Companies that fail to comply or don’t deliver the data on time — as was pointed out in a recent FDA warning letter to Merck — can be liable for fines of up to $1 million. While there is no one-size-fits-all guidance to help manufacturers of a particular drug or drug class prepare for postmarket clinical trials, the FDA has developed guidance on the general requirements of Section 505(o)(3) of the FDAAA and the difference between postmarket requirements and commitments. The agency also issued guidance on how much postmarket safety data companies must collect and when reporting that data can be streamlined. This issue of The Food & Drug Letter updates companies on the FDA’s latest thinking about postmarket studies, the need to back up accelerated approvals with randomized trials and the need for drugmakers to keep the agency apprised of postmarket study progress.
An FDA final guidance highlights changes to the 1938 FD&C Act that give the agency new authority to require postmarket drug studies and clinical trials and make distinctions between postmarket requirements and commitments.
Drug sponsors may be able to collect less and better-targeted safety data in late-stage or postmarket trials if certain aspects of the safety profile are already well established, according to a new draft guidance.
Drugmakers conducting postmarket clinical trials should be required to conduct randomized clinical trials, according to the FDA’s Oncologic Drugs Advisory Committee.
While most drugmakers are good about keeping postmarket clinical trials on schedule, they don’t always file their required annual status reports on time.
The FDA granted approval to Affymax’s and Takeda’s once-monthly anemia treatment Omontys, but has loaded the companies with postmarketing requirements, including two safety studies and a risk evaluation and mitigation strategy (REMS).
An FDA warning that Merck could face fines for being months late on two postmarket study deadlines appears to be the first time the FDA has invoked new enforcement authority for postmarking requirements granted under the 2007 FDA Amendments Act (FDAAA) and may signal a new agency trend, a legal expert says.
For the U.S. to speed new drugs to market and retain its innovative lead, the “FDA should approve drugs based on safety and leave efficacy testing for postmarket studies,” former commissioner Andrew von Eschenbach proposed in a recent opinion piece in The Wall Street Journal.
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