FDA Looks to Buff Up Post-Marketing Safety Image

FDA Looks to Buff Up Post-Marketing Safety Image

April 23rd, 2012 // 1:43 pm @

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Continually on the defensive about its efforts to monitor drug safety, the FDA issued a report over the weekend that trumpets various undertakings to oversee medicines after they have reached the market. Its release comes just as Congress gears up to approve the latest version of the Prescription Drug User Fee Act, or PDUFA, which sets agency funding and is being hotly debated amid concerns over the product-approval process and safety follow up.

The FDA is often criticized, for instance, for not doing more to ensure drugmakers follow through on commitments to conduct post-marketing studies. And the report is a tool the agency hopes will dispel this notion, among others. “We think we’ve really balanced this,” Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, told the media at the Association of Healthcare Journalists annual meeting in Atlanta, accoridng to Reuters.

For instance, the FDA notes that, since 2008, more than 385 post-marketing safety studies were required. A recent progress report was issue (see this). And in a get-tough example of follow through, the agency also declared the Januvia and Janumet diabetes meds sold by Merck were misbranded, because the drugmaker failed to submit an agreed-upon post-marketing study, which was required to assess the risk of acute pancreatitis (back story).

The report offers other data to underscore agency interest in post-marketing safety: since 2008, the FDA required 65 safety-related labeling changes, in addition to changes made voluntarily by drugmakers; last year, CDER issued 68 drug safety communications, up from 39 in 2010; the staff in CDER’s Office of Surveillance and Epidemiology rose to 245 this year from 123 in 2007, and specific safety positions were added in each of the 18 divisions in the Office of New Drugs.

In discussing the staffing expansion, the FDA report maintains that the additions have made it possible to undertake various analyses that made it possible to better assess risks in such medicines as the Avandia diabetes pill sold by GlaxoSmithKline, which the agency restricted last year (see here), and other medications, such as pills taken for treating attention deficit hyperactivity disorder, or ADHD.

The report also notes that, as part of the approval process over the past three years, the FDA required 64 complex REMS, or Risk Evaluation and Mitigation Strategies, some of which include patient registries and restricted access to certain high-risk medications. The number is not surprising, though, given the increasingly complex nature of some medicines, such as biologics.

The FDA report also pointed to the forthcoming Sentinel program, which will use a computer tracking system to help identify safety issues by searching various databases for possible side effects, instead of relying on voluntary reports from drugmakers, doctors and patients. However, the agency did not offer a specific example of how its pilot program, called Mini-Sentinel, has so far been used this way.


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