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

Suggested Articles

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.

Continuing its expansion efforts, Japan’s Fujifilm will make a major investment in its U.S. gene therapy operation in Texas.