Potential FDA Head Could Change Drug Approval Process Dramatically

By Philip PerryBigThink

December 17, 2016

President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. For the last 50 years, commissioners have all had a medical background, either as a doctor or a researcher, but not this Silicon Valley investor. He is familiar with government. In 2002 under the Bush administration, the candidate did a stint as the principal associate deputy secretary for the Department of Health and Human Services.

O’Neill has close ties with billionaire and PayPal co-founder Peter Thiel. Thiel is aiding the Trump team with its Defense Department transition. O’Neill and Thiel were colleagues at Clarium Capital Management. The possible appointee also spent some time managing the Thiel Foundation and a biotech incubator called Breakout Labs. At the latter, he helped biomedicine and food science startups develop and gain a foothold in the market.

Currently, the prospective commissioner is a managing director at Mithril Capital Management, a company owned by Thiel. An inside source close to the Trump team told Scientific American that Thiel was advocating for O’Neill. Yet, some of the investor’s past statements have raised concerns. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what he called “progressive approval.”

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety,” he said in that same speech. “Let’s prove efficacy after they’ve been legalized.”

This is causing alarm among those in Big Pharma and the medical community. What about the placebo effect? Patients could falsely believe they are getting better, when in fact a new medication does nothing for them. What’s more, it may reveal a naiveté on the part of O’Neill, as many say it is impossible to separate safety from efficacy during the assessment process.

President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, “throw the entire U.S. healthcare system into turmoil.” In a legal sense, the 1962 Kefauver amendment would have to be repealed, a law which states that drugs must be proven safe and effective before they can make it to market. […]

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