Tuesday, May 7, 2013
From Weil, Gotshal & Manges by Christopher D. Barraza FDA Flexing its Muscle with Compounding Pharmacies
Weil, Gotshal & Manges LLP in New York, NY C
Last week, my colleague wrote about proposed legislation in the Senate that would increase FDA oversight of compounding pharmacies. As the bill works its way through the legislative process, we thought it might be helpful to talk more about how FDA has been conducting oversight of compounding pharmacies within the existing regulatory framework. The short answer is that in the wake of New England Compounding Company meningitis outbreak last fall, FDA has brought a record number of enforcement actions.
Consider this statistic: FDA has pursued more enforcement actions in the first four months of 2013 than in the previous five years combined. Thus far this year, FDA has issued almost four dozeninspectional observations, which are often referred to as “Form 483s” or “483s,” compared with approximately two dozen 483s and warning letters from 2008 through 2012. FDA is authorized to perform inspections of compounding pharmacies under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC §374) and uses 483s to document and communicate concerns discovered during these inspections. Although Form 483s are not a final agency determination, they are often a precursor to regulatory action, which can include a formal warning letter, withholding of product approval, or plant shut down. And 483s yield results: FDA’s stepped up oversight has lead to six voluntary recalls by compounders so far in 2013.
There are questions about how long FDA can sustain its recent enforcement action pace, since focusing on compound pharmacies requires FDA to shift resources from other areas. What is clear, though, is that regardless of pace, FDA is now very much engaged on the issue of regulatory oversight of compounding pharmacies and will continue to pay particular attention to this issue. Whether that will result in more litigation remains to be seen but FDA tighter regulation often brings more private lawsuits in its wake. We will continue to monitor developments in this area.