Consent decree trumps prosecution in some cases

Last week's J&J/McNeil recall of Tylenol caplets marks its 13th in just over a year. That's enough for Donald Riker, president at healthcare industry consultancy On Point Advisors. 

Riker, using his OTC Product News platform, has called for the FDA to seek a judicial consent decree governing J&J's manufacturing of OTC products. "Despite warning letters, FDA monitoring and plant shut-downs it's time for the public health to come first," he writes.

The consent decree is the tool of choice in this case because it is best suited to remedy a systemic failure that is repeated, says Riker in an email. He says that in this case, it's even preferable to any attempt at criminal prosecution--the tool that FDA has been threatening to use against repeat regulatory offenders throughout the drug and medical device community since early this year. "There is a chance of their acquittal," says Riker. "And it does not guarantee change of systems or final product."

- here's the call

Suggested Articles

Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects.

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.