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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After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

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