GSK Paxil, Avandamet Seizure Will Have “Ripple Effect” On GMPs, FDAer Says
This article was originally published in The Pink Sheet Daily
FDA hopes the seizure will serve as a warning to other manufacturers that do not heed guidelines for good manufacturing practices. The decision to bypass other regulatory options was made in consultation with Acting Commissioner Crawford. FDA is currently negotiating a consent decree with GSK.
You may also be interested in...
Crawford’s time as permanent FDA commissioner lasted less than three months and ended in scandal, but with that stint and his longer stretches as acting commissioner, he oversaw the agency through several historic moments that continue to influence the current regulatory environment.
Baxter resolves US plant’s GMP whistleblower allegations for just $18m, a bargain compared to the $750m GlaxoSmithKline paid in 2010 and the $500m Ranbaxy paid in 2013. One reason: it was more narrowly focused.
Assistant Commissioner for Counterterrorism Margaret Glavin is named associate commissioner for regulatory affairs. She takes over for John Taylor, who is leaving FDA after 14 years. Glavin brings a background in food safety from her work at the Department of Agriculture.