FDA and outsourced drug making

Dick Taffe — Tue, 15 Jun 2010 22:15:03 +0000

The Food and Drug Administration reportedly will propose tougher regulations for pharmaceutical companies that outsource manufacturing of drugs, making them more responsible for the safety and purity of the products made by contractors. Law Professor Kevin Outterson, an authority on food and drug law and director of the Healthy Law Program, says the changes likely will have little effect because branded drug manufacturers put their reputations on the line every day with their drugs already.

“I’d be surprised if the FDA requirements are a great improvement over what Pfizer and Merck already do to protect the integrity of their supply chain.”

Contact Kevin Outterson, 617-353-3103, mko@bu.edu

Drug firm snoops on FDA officials

Dick Taffe — Wed, 31 Mar 2010 21:53:24 +0000

Amphastar Pharmaceuticals reportedly paid more than $100,000 to a private investigative firm to snoop on FDA officials they suspected of having a too-chummy relationship with a competitor drug maker. Amphastar insists it did nothing wrong, but Senate Finance Committee investigators are looking into the case. Law Professor Kevin Outterson, an authority on drug law and marketing, says it’s disturbing.

“I don’t know what is more disturbing: that Amphastar hired the private detectives or that they are unapologetic about it after being caught.”

Contact Kevin Outterson, 617-353-3103, mko@bu.edu

BU Now » Food and Drug Administration

FDA and outsourced drug making

Drug firm snoops on FDA officials