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Lets prove drug efficacy after sponsors demonstrate safety

May 30

Written by: Del Meyer
05/30/2017 5:43 AM 

Donald Trump Looking Beyond Traditional Medical Experts for FDA Commissioner

Meeting with Silicon Valley investors backed by billionaire investor Peter Thiel

By THOMAS M. BURTON | The WSJ | Jan. 14, 2017

President-elect Donald J. Trump is reaching beyond traditional medical experts in his search for a new Food and Drug Administration commissioner, scheduling meetings for the FDA job with two Silicon Valley investors backed by billionaire investor Peter Thiel.

The two are James O’Neill, a managing director of the investment firm Mithril Capital Management, and Balaji S. Srinivasan, a venture capital board member who founded the genetic-counseling firm Counsyl Inc.

Neither one is a medical doctor, which has been a traditional qualification for FDA commissioners. Mr. Srinivasan holds a Ph.D. in electrical engineering from Stanford University.

Of the two, Mr. O’Neill would appear to face the more difficult road to getting approval from the Senate, because his stated views run counter to existing FDA law and regulation. In a 2014 speech, he took the position that drugs shouldn’t have to be proven effective before putting them on the market.

“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 at a conference called Rejuvenation Biology. “Let’s prove efficacy after they’ve been legalized.”

Mr. O’Neill was a principal associate deputy secretary of the Department of Health and Human Service under President George W. Bush.

A Trump transition official said that Mr. Trump was to meet with Messrs. O’Neill and Srinivasan this past Thursday and Mr. Thiel the day before. Attempts to reach them through Mr. Thiel’s press spokesman and the Trump transition office were unsuccessful.

People familiar with the Trump transition said another person under consideration for the top FDA job is Scott Gottlieb, a medical doctor and prominent conservative thinker on medical regulatory issues. Dr. Gottlieb served as deputy commissioner of the FDA for medical and scientific affairs from 2005 to 2007. He was previously chief policy adviser to the Medicare agency, also under Mr. Bush. For about a decade, Dr. Gottlieb has been a resident fellow at the conservative think tank American Enterprise Institute.

Since the 1962 Kefauver amendments to the federal food and drug law, it has been a keystone principle of U.S. medical regulation that drugs and medical devices must be proven both safe and effective before they are put on the market.

“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 at a conference called Rejuvenation Biology. “Let’s prove efficacy after they’ve been legalized.”

Mr. O’Neill was a principal associate deputy secretary of the Department of Health and Human Service under President George W. Bush.

A Trump transition official said that Mr. Trump was to meet with Messrs. O’Neill and Srinivasan this past Thursday and Mr. Thiel the day before. Attempts to reach them through Mr. Thiel’s press spokesman and the Trump transition office were unsuccessful.

People familiar with the Trump transition said another person under consideration for the top FDA job is Scott Gottlieb, a medical doctor and prominent conservative thinker on medical regulatory issues. Dr. Gottlieb served as deputy commissioner of the FDA for medical and scientific affairs from 2005 to 2007. He was previously chief policy adviser to the Medicare agency, also under Mr. Bush. For about a decade, Dr. Gottlieb has been a resident fellow at the conservative think tank American Enterprise Institute.

Since the 1962 Kefauver amendments to the federal food and drug law, it has been a keystone principle of U.S. medical regulation that drugs and medical devices must be proven both safe and effective before they are put on the market.

Some in academic medicine have expressed surprise about Mr. O’Neill’s candidacy.

“This will set back the competitiveness of the American pharmaceutical industry, which is the envy of the world, by 50 years,” said Dr. David A. Kessler, who served as FDA commissioner under both Presidents George H.W. Bush and Bill Clinton. “When the industry sells a drug, the drug works, and it does what it says on the label. Take that away and we go back to snake oil.”

Mr. Srinivasan, a board member of the venture-capital firm Andreessen Horowitz, created the startup 21 Inc. focused on use of the virtual currency bitcoin. Another company he started, Counsyl, in South San Francisco, does genetic testing for couples considering having children.  The company offers genetic tests for more than 100 genetic disorders. Its website says it produces “results you can act on,” adding, “We screen for conditions where early awareness can make a difference.”

While the FDA has been critical of some diagnostic testing companies in recent years, Counsyl has won praise. “It’s a dynamic genomic testing company that has done a good job of pushing innovation while being responsible and responsive to the medical culture,” said Harvard Medical School geneticist Robert C. Green. . .

Write to Thomas M. Burton at tom.burton@wsj.com

Read the entire report:  http://www.wsj.com/articles/donald-trump-looking-beyond-traditional-medical-experts-for-fda-commissioner-1484315356

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