Potential Picks to Lead FDA Would Shake Up Agency

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By Bronwyn Mixter

The two names being floated as potential nominees for FDA commissioner are in line with President-elect Donald Trump’s campaign pledge to shake up Washington.

Jim O’Neill and Scott Gottlieb both have publicly expressed ideas that would significantly change the way the Food and Drug Administration operates, attorneys and others told Bloomberg BNA. O’Neill, a managing director at Mithril Capital Management, has said the FDA should approve drugs based solely on their safety and not, as the agency currently does, based on their safety and effectiveness. Meanwhile, Gottlieb, a resident fellow at the American Enterprise Institute, favors deregulation and loosening the agency’s requirements for the approval of medical products.

Patients taking drugs approved solely on safety wouldn’t know whether the drugs actually work for their particular disease or condition. Also, drug manufacturers wouldn’t be able to promote the effectiveness of a drug in order to distinguish their product from competing products. And loosening approval standards could lead to unsafe or ineffective products, which could harm patients.

Gottlieb is the more experienced candidate, having worked at the agency as a deputy commissioner and also having a medical degree, attorneys told Bloomberg BNA. But the fact that both candidates have ties to FDA-regulated industries should disqualify them, a consumer group told Bloomberg BNA.

Agents for Change

Michael Gaba, a life sciences attorney with Holland & Knight in Washington, told Bloomberg BNA in a Dec. 15 e-mail that “President-elect Trump appears to be keeping his campaign pledge to shake up Washington—not only with his Cabinet choices, but with the lack of predictability that precedes them. So while both Jim O’Neill and Scott Gottlieb represent ‘change agents,’ I would be surprised if theirs are the only two names floated before President-Elect Trump reveals his pick for FDA Commissioner.”

Gaba said that between the two men, Jim O’Neill would be the extreme “shake-up candidate.”

“I say this because as a self-proclaimed libertarian, he’s on record as saying that the FDA should limit itself to judging the safety of a product before it’s allowed on the market,” Gaba said. “Well, that flies in the face of what the law requires. Both medical device and drug approvals require that the FDA review and approve safety and effectiveness data.”

But Gaba said a statutory change would be needed to implement a safety-only approval standard at the FDA.

“At the end of the day, industry, patients, and physicians all want to know that medical devices and drugs are indeed safe and effective for their intended uses,” Gaba said. “Physicians and patients want to know the products work—this is more than just knowing they won’t harm you—otherwise they are not likely to be prescribed or taken.”

Gaba also said manufacturers “want to be able to make claims about what their products do to help patients, and in a manner that distinguishes them among competitors in the marketplace.”

Industry Ties, Experience

Gaba said that even though Gottlieb “has industry ties he’d have to address (which does not distinguish him from O’Neill and many of the President-elect’s Cabinet appointees), he does bring relevant experience and credentials that should resonate with the new administration.”

Gottlieb is “an outspoken physician who leans right, placing significant emphasis on preserving the physician-patient relationship and decision-making process,” Gaba said. “And as a former deputy commissioner of the FDA, he has a solid understanding of how the agency works.”

Gottlieb served as FDA deputy commissioner for medical and scientific affairs from 2005 to 2007.

Michael Carome, director of Public Citizen’s Health Research Group, told Bloomberg BNA Dec. 15 Gottlieb “obviously is more qualified in terms of his resume” and “he certainly has more appropriate experience to be considered as a candidate.”

But Carome said Public Citizen is concerned Gottlieb “would advance a deregulatory approach to the agency” and “he’s articulated policies which favor loosening the standards and the rigor of the review and approval of drugs and medical devices.”

Gottlieb also has articulated views that “favor loosening the restrictions on off-label promotion and the distribution of information by drug and medical device companies about off-label uses,” Carome said.

“We think those are taking us in the wrong direction from a public health standpoint in terms of protecting patients from drugs that are either unsafe or ineffective,” Carome said.

Gottlieb “also has a wide array of industry ties, financial ties, serving on boards of various companies,” Carome said. “I think that alone should be disqualifying. I think it would be hard for him to extricate himself from all those industry ties. His conflicts would be irreconcilable.”

Gottlieb, in addition to being a resident fellow at the American Enterprise Institute, is a venture partner at New Enterprise Associates. New Enterprise Associates is a venture capital firm that invests in medical and life sciences companies, among other things. AEI is a nonpartisan public policy research institute.

O’Neill is “totally unqualified” to be the FDA commissioner, Carome told Bloomberg BNA.

O’Neill “comes from a high executive position at a hedge fund that invests in companies that make medical products regulated by the FDA. He’s not a physician. He doesn’t have an advanced degree in any scientific field, like a PhD in pharmacology or some related science. He doesn’t have a JD or any experience in law. So just by his background, he’s not qualified,” Carome said.

O’Neill’s firm, Mithril Capital Management, is an investment firm that has invested in the medical device firm Fractyl Laboratories Inc. It also invested in Avitide Inc., a manufacturer of purification solutions for the biopharmaceutical industry. O’Neill last served in government during the George W. Bush administration as principal associate deputy secretary at the Department of Health and Human Services.

Praise for Gottlieb

Gottlieb “would be a great choice for FDA commissioner,” John Kamp, executive director of the Coalition for Healthcare Communication in New York and consulting counsel to Wiley Rein LLP, told Bloomberg BNA in a Dec. 13 e-mail.

“He’s a doctor with experience at FDA as deputy commissioner,” Kamp said. “He’s a solid conservative with a track record working on difficult regulatory issues, working with Congress and with the FDA career staff.”

Kamp said Gottlieb “is the best choice among those reported to be under consideration.”

The Coalition for Healthcare Communication promotes the free exchange of scientific and medical information. It is composed of media, health-care and other organizations.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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