FDA's prosecution talk has consent decree ring

There's an interesting parallel between FDA deputy chief counsel Eric Blumberg's remarks from last week and comments he made in 2002. Then as now, the issue is the regulator's need for more powerful means of enforcement against drugmakers who flout manufacturing and marketing regulations.

Last week, Blumberg was talking about the agency's intent to pursue misdemeanor prosecutions of individuals at drug companies, especially those guilty of repeat regulatory violations. The regulator needs an effective tool. His remarks in 2002 followed the signing of a consent decree agreement with Schering-Plough that involved an eyebrow-raising $500-million penalty plus potential missed-deadline fines, in addition to a manufacturing halt on 73 products. In both instances, Blumberg refers to the FDA needing to extricate itself from the situation of issuing warning letter after warning letter (.pdf) to the same company, to little or no effect. In 2002, it was the warning letters that weren't working. Today, it's consent decrees.

It's difficult to imagine big-fine consent decrees being ineffective. Like the one now governing Genzyme operations, they carry a long-lasting sting and affect a company's viability and competitiveness. And few of those issued have ever been closed out; some have been in place now for two decades.

So before we have that first executive prosecution to talk about, which some expect within the next six months, we've provided a summary of the consent decree analysis recently completed by consultancy PRTM.

- here's the Bloomberg story
- see the consent decree report


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.