FDA to address deficiencies in post-marketing surveillance

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Over 80% of the manufacturers that submitted postmarketing information to FDA met their obligations, despite weaknesses in FDA's monitoring and tracking of postmarketing requirements (PMR) and postmarketing commitments (PMC), an FDA-commissioned study found.

“Most sponsors take the completion of PMRs and PMCs very seriously,” said John Jenkins, director, office of new drugs, CDER, in a media briefing this morning, adding that FDA regrets the shortage of staff and resources that contributed to the backlog.

As a result of the study – and new financial allowances from Congress – FDA has “already initiated steps to improve efficiency,” said Jenkins. At the end of July, FDA created a new database in the Document Archiving and Records Retention System (DARRTS) that includes “increased capabilities for data capture, tracking, and generating reports related to postmarketing studies,” according to a statement. Additionally, FDA established new positions – a postmarkeing study development coordinator and a tracking coordinator – within each new drug division.

The study (here, in pdf) reviewed 1,531 PMRs/PMCs and found that 51% of them had an inaccurate status and required an update. After the statuses were updated, 569 (36%) of the PMRs/PMCs were changed to “submitted” status. Jenkins said FDA has already taken action on 201 of those, and that 151 were fulfilled, 19 released, 18 changed to a new category, and 13 were deemed unacceptable. Additionally, 244 of the 1,531 PMRs/PMCs in the backlog have since been closed, said Jenkins.    

FDA contracted Booz Allen Hamilton to review its backlog of PMRs and PMCs going back to September 27, 2007, responding to Section 921 of the Food and Drug Administration Amendments Act of 2007. FDA's fiscal year ends on September 30, and Section 921 requires FDA to review its entire backlog on an annual basis. The study looked at the backlog through February 22, 2009.

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