FDA

FDA executes an abrupt about-face as sole-source contract for ex-agency chief Mark McClellan draws the spotlight

Mark McClellan

After nominating Scott Gottlieb for FDA commish last year, Mark McClellan, his former boss at the agency, offered a warm endorsement for the move.

“(Gottlieb) knows how to get things done in a policy environment, working with not just people in Washington, but industry, patient groups and all kinds of stakeholders on important public health initiatives,” McClellan told the campus paper at Duke, where he is director of the Duke-Margolis Center for Health Policy.

That close relationship raised a few eyebrows, though, when the FDA recently set up a contract where McClellan’s center was the sole allowed bidder. McClellan’s role as a board member of pharma giant J&J also came into the harsh spotlight.

From the request for proposal:

The primary objective of this effort is to provide supporting research, identify key issues, and convene appropriate subject matter experts to help inform major initiatives for process improvement and regulatory science related to FDA commitments under the 2018 reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act legislation.

Politico raised some pointed criticism, as did the Washington Post.

Jerry Avorn

“It frankly makes no sense that the only place you could go from this is the Duke center run by a drug company advocate,” Jerry Avorn, a professor of medicine at Harvard Medical School, told the Post. “The very fact that they could have thought this was a good idea, even to the point of publishing the request for proposal, is important because of what it reflects about the decision-making process within FDA and the administration.”

And then, yesterday, the FDA suddenly did an about face, saying that they had become aware of other groups that could offer a rival bid. A spokesperson sent this statement:

Since posting our original sole source award announcement online, we have become aware of other organizations who believe that they can submit a competitive proposal to conduct the needed research and related activities. As a result, FDA has decided to change the announcement from a sole source award to an open competitive grant.


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