Three candidates whom President Trump is considering for FDA commissioner are likely to speed drug approvals, analysts say.
Joseph Gulfo, MD, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, is on Trump's shortlist for FDA commissioner. Gulfo, an author and the former president and CEO of medical device firm MELA Sciences, would also likely speed drug and device approvals and potentially overhaul FDA.
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Jim O’Neill, managing director of Mithril Capital Management and a founding member of the Coalition for Cannabis Policy Reform, is expected to eliminate some of FDA’s red tape on drug approvals. Scott Gottlieb, MD, a partner at New Enterprise Associates and a former FDA Deputy Commissoner, is also conservative and may aim to reform FDA.
“All three would bring different sets of skills and experiences to bear on the same goal, accelerating the development of new medicines, devices and diagnostics, and reducing the time and cost required to making this happen," Robert Goldberg, PhD, medical economist and founder of Center for Medicine in the Public Interest, told FormularyWatch.
“If O’Neill gets the nod, he could implement progressive approval for drugs,” wrote Patrick Cox in a recent Forbes article. O’Neill has supported proposals to do away with FDA’s requirement for phase 2 and 3 trials, according to Cox. Instead, he prefers “progressive approval” of drugs and medical devices.
For example, Japan’s government legalizes medicines following proof of safety. “Once a drug is in use, companies can move to phase 4. This means they monitor their patients and disclose efficacy data regularly,” Cox wrote.
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“The intent and letter of the original law [establishing FDA] is to promote health by ensuring safety and effectiveness [of medical products], but that has migrated over the years slowly and steadily…like a chronic, insidious disease,” Gulfo told Regulatory Focus. “What I’ve proposed is getting FDA back to safety and effectiveness…and we can do this one of four ways: with biomarkers, clinical science and symptoms (ie., blood pressure, tumor size), with disease modification (bouts of migraines per month) and lastly with long-term outcomes.”
Faster FDA drug approvals could also lead to lower overall prices, according to Gulfo in Regulatory Focus. “If approvals on a calendar basis were shortened, even by just two years, there are models that the contribution of development time to approval would mean less of a need for price increases and more exclusivity…those two years would reduce the development expenses and then with longer exclusivity, companies can recoup their R&D funds easier.”
“What Dr Gulfo said is accurate," Goldberg said. "Getting to market by even two years could shave billions off of the cost of development. That would increase competition, reduce prices and lead to increased US investment in biotechnology.”
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