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Trump's FDA pick could undo safeguards

By Katie Thomas

WASHINGTON – President Trump’s vow to overhaul the Food and Drug Administration could bring major changes in policy, 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 official at the Health and Human Services Department 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 that their drugs work in clinical trials before selling them to consumers.

Other candidates also have called for reducing regulatory hurdles.

If the most significant proposals are adopted – and many would require an act of Congress – they will reverse decades of policy and consumer protections dating to the 1960s. Congress toughened the drug approval process in the wake of the 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 watchdog for protecting the safety of food and drugs, a gold standard whose lead other countries often follow.

Trump’s most recent statements, made at a White House round-table discussion last week with leaders of the nation’s top drug companies, have reverberated throughout 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 based on junk science.

“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, who was commissioner of the FDA 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 at the meeting that he was close to naming a “fantastic” person to lead the agency. In addition to O’Neill, candidates whose names have recently surfaced include Dr. Scott Gottlieb, a former FDA official with long-standing ties to pharmaceutical and biotech companies, and Dr. Joseph Gulfo, a former biotech and medical device executive.

All three have called for streamlining the drug approval process, but O’Neill’s stance has drawn the most attention. He is a managing director of Mithril Capital Management, an investment firm Thiel co-founded, and previously led the Thiel Foundation, Thiel’s philanthropic organization. During the George W. Bush administration, O’Neill held a series of roles in the Health and Human Services Department, including as principal associate deputy secretary, where he worked on policy, including for the FDA, according to his LinkedIn profile.

O’Neill is a libertarian who is on the board of the SENS Research Foundation, a charity that funds anti-aging research, and until recently served on the board of the Seasteading Institute, an effort to create new societies at sea.

At an anti-aging conference in 2014, O’Neill advocated something he called “progressive” approval, in which drugs that were proved safe, but not yet proven 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, when Congress passed legislation requiring that licensing for sale be based not just on safety but also on “substantial evidence” of a drug’s efficacy. That law, and others passed since, forced companies to rigorously test their products, running them through a gantlet of clinical trials whose results are then vetted by the FDA before any sales to consumers. 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, newly discovered drugs can take years to reach the market, a period that Trump said last week was too lengthy.

“When you have a drug, you can actually get it approved if it works, instead of waiting for many, many years,” he told the 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.”

Some have suggested that a commissioner determined to weaken the efficacy standard need not seek congressional action, but could interpret existing regulations loosely so that requirements for certain clinical trials – particularly the costly, large-scale ones that can take years and involve thousands of patients – can be rolled back.

That could have serious implications for patients. Last month, the FDA released a study of 22 drugs that appeared promising in early studies but failed in final, large-scale trials. Drug safety watchdogs point to examples like the painkiller Vioxx, which was withdrawn from the market in 2004 over safety concerns, as proof of the high stakes involved in drug approval.

While Trump’s call to cut regulations has been warmly received by other industries, some biotech executives have reacted to his remarks with alarm. Those affiliated with some smaller companies have privately described the choice of O’Neill as a worst-case scenario that could send the drug industry into chaos. The FDA, they say, is not perfect, but its standards provide a level playing field on which both big and small companies can compete.

“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, the chief executive of Alnylam Pharmaceuticals, a Massachusetts biotech firm. “Our products are lifesaving medicines.”

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