Hamburg Promises Quicker Enforcement as FDA Spews Warning Letters
This article was originally published in The Gold Sheet
Hair-trigger enforcement seen as FDA sends in U.S. Marshals and negotiates consent decrees in cases without even first issuing warning letters. The agency is pushing more redacted Form 483 reports onto the web, while the second quarter warning letter rate is back up to Clinton administration levels. Meanwhile, Commissioner Hamburg announces six initiatives to expedite enforcement. Chief among them is a decision to limit Office of Chief Counsel reviews of warning letters. Another is a time clock on Form 483 responses. Additional measures would strengthen ties with other countries' enforcement agencies and establish quicker follow-up and closeout of enforcement cases. Caraco, Clarcon and Teva Animal Health quick-response cases described.
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Interactive map, charts provide details on our analysis of FDA 2009-2014 inspection results data showing that even as the agency responded to the threat of poor drug quality abroad, it was more successful at finding serious quality issues during its much more numerous domestic inspections.
FDA inspection results data show that even as the agency responded to the threat of poor drug quality abroad in fiscal years 2009-2014, it was more successful at finding serious quality issues during its much more numerous domestic inspections. Asian inspections were somewhat more likely to identify serious issues than US ones, while European inspections were much less likely to raise any, and neither identified nearly as many.
Initial responses to Form 483 reports don’t have to be completely thorough, but they must arrive within 15 days, an FDA investigator says. Other advice from investigators includes pointers on how to tell if the findings are egregious.