The Senate health committee voted 14-9 Thursday to approve physician Scott Gottlieb to be the next commissioner of the Food and Drug Administration, sending the nomination to the full Senate.
Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor and Pensions Committee, called Gottlieb “the right person to lead the Food and Drug Administration in its vital mission and move the agency forward.”
But Sen. Patty Murray of Washington, the committee's ranking Democrat, said she voted no because Gottlieb's “entanglements with the industries he will be charged with overseeing are unprecedented.”
Murray said his responses to senators' questions about his past pharmaceutical connections were sometimes vague and “did little to address my concerns about whether Dr. Gottlieb is truly committed to putting families’ health first.”
Gottlieb, who was a partner in the large venture capital firm New Enterprise Associates, said in federal ethics filings earlier this year that he would recuse himself from agency decisions for a year involving more than 20 companies he has worked for, invested in or had some other kind of financial relationship with.
Gottlieb, a cancer survivor, has been endorsed by many medical and patient groups. Ellen Sigal, chair of the advocacy group Friends of Cancer Research, said Thursday she's confident Gottlieb will ensure that “FDA keeps pace with science and innovation” while maintaining the agency's standards.
Gottlieb's previous work continues to raise concerns, however. Five senators sent a letter Thursday asking him whether he ever provided services for the drug company Cephalon or a subsidiary, Anesta, before his 2005 to 2007 stint at the FDA. They also asked whether he worked for Cephalon, Anesta or Teva Pharmaceutical Industries, which acquired Cephalon in 2011, after he left the agency.
The Washington Post reported Monday that Gottlieb participated in a December 2006 meeting with the Drug Enforcement Administration in which FDA officials requested an additional allotment of fentanyl for Cephalon. The DEA denied the request.
At the time, the drugmaker was under investigation by the FDA and the state of Connecticut for illegally promoting lollipops containing the opioid for everything from back pain to headaches. A former FDA lawyer has described Gottlieb’s involvement in the meeting as minimal, and documents show that FDA officials were worried about a shortage of the lollipops for cancer pain.
In 2008, Cephalon pleaded guilty to illegally promoting the fentanyl lollipops — marketed under the name Actiq — and two other drugs. The company paid a $425 million fine.
There is nothing in Gottlieb’s financial disclosures to indicate he received money from Cephalon. But the five Democratic senators — Edward J. Markey (Mass.), Elizabeth Warren (Mass.), Maggie Hassan (N.H.), Sherrod Brown (Ohio) and Whitehouse — said that court documents show he served as an expert witness for Cephalon in a class-action lawsuit after he left the FDA.
They asked Gottlieb to list instances when he was an expert witness for the company, how much he was paid and by whom.