Critics question FDA nominee's involvement in Cephalon's 2006 fentanyl shortage

Critics of Scott Gottlieb, MD — President Donald Trump's pick to head the Food and Drug Administration — question his involvement in helping the drugmaker Cephalon acquire more fentanyl during a 2006 shortage, reports The Washington Post.

Here are six things to know.

1. In December 2006, Cephalon had a dwindling supply of the opioid fentanyl, which it put in a lollipop to treat severe pain in cancer patients, according to the report.

2. At the time, Cephalon was also under investigation for urging physicians to prescribe the drug for other uses, like headaches and back pain, despite strict treatment restrictions from the FDA. The drugmaker pleaded guilty to illegally promoting the lollipops — called Actiq — in 2008 and agreed to a $425 million fine. Teva Pharmaceuticals acquired Cephalon in 2011.

3. As deputy commissioner of the FDA, Dr. Gottlieb and several other agency officials worked to help Cephalon access more fentanyl during the shortage, reports The Washington Post.

4. Sheldon Bradshaw, a former attorney for the FDA, said Dr. Gottlieb's involvement in the situation was limited to one meeting with other FDA and DEA officials on Dec. 6, 2006. As a deputy commissioner, Dr. Gottlieb had a responsibility to protect patients in severe pain from potential shortages of a crucial medication, Mr. Bradshaw told The Washington Post.

5. Critics say Dr. Gottlieb's participation in the Cephalon situation demonstrate conflicts of interests they fear could occur if he's confirmed to lead the FDA, since he's known to have extensive ties to the drug industry.

6. Dr. Gottlieb declined The Washington Post's request for comment. A Senate committee is expected to vote on his nomination Wednesday.

More articles on supply chain:

FDA finalizes decision to keep impounded execution drugs from Texas justice system
Sanofi epilepsy drug linked to birth deformities
Sanofi launches antitrust suit against Mylan over EpiPen competition

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars