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