Business

Trump’s FDA pick could undo decades of drug safeguards

NEW YORK, NY - JANUARY 12: Jim O'Neill, managing director of Mithril Capital Management, arrives at Trump Tower, January 12, 2017 in New York City. President-elect Trump continues to hold meetings Trump Tower. (Photo by Drew Angerer/Getty Images)

Drew Angerer/Getty Images

Jim O'Neill at Trump Tower in January.

President Trump’s vow to overhaul the Food and Drug Administration could bring major changes, including steps to accelerate the process of approving new prescription drugs, setting up a clash with critics who say his push for deregulation might put consumers at risk.

Trump has been vetting candidates to run the agency, which regulates the safety of everything from drugs and medical devices to food and cosmetics. Among them is Jim O’Neill, a former Health and Human Services official who is an associate of the Silicon Valley billionaire and Trump supporter Peter Thiel. O’Neill has argued that companies should not have to prove their drugs work in clinical trials before selling them.

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Other candidates also have called for reducing regulatory hurdles.

If the most significant proposals are adopted — many would require an act of Congress — they would reverse decades of policy and consumer protections dating to the 1960s. Congress toughened drug approvals after a worldwide crisis over thalidomide, which caused severe birth defects in babies whose mothers had taken the drug in pregnancy. Since then, the FDA has come to be viewed as the world’s leading food and drug safety watchdog.

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Trump’s most recent statements have reverberated in the medical and pharmaceutical industries. Supporters of deregulation have long wanted to reduce bureaucracy and lessen oversight of drugs and devices, while critics say the market for drugs could be destabilized and the door opened to unproven products.

“Everyone depends on the agency, from the drugs in our medicine cabinet to the food on our dinner table, to our blood supplies,” said Dr. David Kessler, FDA commissioner during the presidencies of George H.W. Bush and Bill Clinton. “We are the envy of the world because our honey is our honey. Our foods are not laced with pesticides. Our drugs work.”

Trump said he was close to naming a “fantastic” person to lead the agency. In addition to O’Neill, candidates whose names have surfaced include Dr. Scott Gottlieb, a former FDA official with longstanding ties to pharmaceutical and biotech companies, and Dr. Joseph Gulfo, a former biotech and medical device executive.

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All three have called for streamlining drug approval, but O’Neill’s stance has drawn the most attention. He is a managing director of Mithril Capital Management, an investment firm Thiel cofounded, and previously led the Thiel Foundation, Thiel’s philanthropic organization.

In the George W. Bush administration, O’Neill held roles at Health and Human Services including principal associate deputy secretary, where he worked on policy, according to his LinkedIn profile.

In 2014, O’Neill advocated something he called “progressive” approval, in which drugs that were proved safe — but not effective — could be allowed on the market. “Let people start using them, at their own risk,” O’Neill said. “Let’s prove efficacy after they’ve been legalized.”

Companies have been required to prove that their drugs work since 1962. Laws force companies to rigorously test their products, running them through a gantlet of clinical trials whose results are then vetted by the FDA. Ninety percent of drugs that enter clinical development fail these trials. (The FDA also regulates medical devices, but they undergo a separate approval process.)

As a result, drugs can take years to reach the market.

“When you have a drug, you can actually get it approved if it works, instead of waiting for many, many years,” Trump told pharmaceutical executives. “We’re going to be cutting regulations at a level that nobody’s ever seen before, and we’re going to have tremendous protection for the people.”

“We’re not selling Coca-Cola and Pepsi, where patients can taste the Coca-Cola and decide if they like it,” said John M. Maraganore, CEI of Alnylam Pharmaceuticals, a Massachusetts biotech firm. “Our products are lifesaving medicines.”

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