What a week! As I’ve said the past few weeks, change, change, change – not only the way that medical products are approved, but the way they are marketed and who is overseeing the agency that regulates one-fourth of the economy.
But aside from the big news, here is a bit of what happened this week:
- FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer – At the request of FDA, U.S. Marshals seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio, five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant activity.
- Lots of Buzz About Who the Next FDA Commissioner Is Going to Be – Nissen, Nissen, Nissen. Lots of people saying that Steven Nissen, well known for his work on the Cardiovascular Drugs Advisory Committee during the Vioxx/COX-2 safety meetings and for the well-known issues associated with Avandia and the Congressional hearings around that project. Some are saying FDA-long-timer Dr. Janet Woodcock, a nice choice, but not one connotating change. Many are advocating for a real consumer protection figure. Some have said Dr. Howard Dean, now the head of the Democratic National Committee, though one would imagine him having higher aims. Some have offered names of lawyers, though Democrats usually prefer MDs. I may put up a vote counter next week.
That’s it for me this week. I’m exhausted.