FDA

Ex-Mela chief Gulfo joins the list of would-be FDA commish candidates, color-coded drug approval plan in hand

Joseph Gulfo

A few weeks ago, Joseph Gulfo spurred a considerable round of chatter around a proposal for a color-coded approach to approving new drugs. Essentially, he wants drug developers to be able to gain an OK based on a range of factors, including biomarker evidence of efficacy.

Now, Gulfo’s name has been raised — by STAT — as another possible candidate for the top job at the FDA, as the biopharma industry anxiously awaits word on the next commissioner and how President Trump plans to deliver on a promise to speed up new approvals even as he batters the industry with criticism of its pricing strategies.

In a recent op-ed for The Hill, Gulfo wrote:

Clinical utility and clinical benefit are highly subjective and personal experiences, best judged by patients and their doctors.

Whether to use a drug (based on the potential benefit and risk tolerance of the patient), or to continue using a drug given the benefit-risk profile in the individual patient, is a personal health decision.

That approach is more along the lines of the Libertarian positions taken by two other rumored candidates for top jobs at the FDA. Both Jim O’Neill and Balaji Srinivasan want to drop standards that they believe have kept drugs out of the marketplace, which can best decide on their proper use. O’Neill famously said that drugs should be approved based on safety alone, an approach that Gulfo describes as selling “safe snake oil,” STAT reports.

“The FDA has increasingly added new hurdles for pre-approval requirements by demanding long-term outcomes and survival,” Gulfo maintains. “A great example of this is in the approval of Praluent and Repatha, medicines that lower LDL cholesterol.”

Gulfo had his own controversial experience with the FDA, pursuing a lengthy campaign to gain an approval for Mela Science’s MelaFind system, even as experts warned of its possible misuse. In the words of MassDevice:

Mela Sciences, and Gulfo, became something of a poster child for charges of unpredictability at the FDA during the prior decade.

It’s hard to say how far Gulfo’s candidacy can get. STAT’s report indicated that he had met with a couple of members of Trump’s transition team, which is a far cry from an actual face-to-face with the president.

Scott Gottlieb remains a widely rumored candidate for Commissioner as well. But he’s been able to keep a low profile recently, unlike the other rivals for this position.


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