FDA and outsourced drug making

pillsThe 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

Post a Comment

Your email address is never shared. Required fields are marked *