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.
Mr. 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. Mr. 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 F.D.A. 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.
Mr. 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 F.D.A. during the presidencies of the elder George 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.”
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At an anti-aging conference in 2014, Mr. 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,” Mr. 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 F.D.A. before any sales to consumers. Ninety percent of drugs that enter clinical development fail these trials. (The F.D.A. also regulates medical devices, but they undergo a separate approval process.)
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While Mr. 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 Mr. O’Neill as a worst-case scenario that could send the drug industry into chaos. The F.D.A., they say, is not perfect, but its standards provide a level playing field on which both big and small companies can compete.
Industry executives said big changes to the agency would also be bad for business, making it difficult for companies with breakthrough treatments to distinguish their products from those that are shams. If standards at the F.D.A. are rolled back, “then we might as well be advertising in the middle of the night on how terrifically we can cure all your illnesses,” said Dr. Leonard S. Schleifer, the chief executive of Regeneron, a pharmaceutical company in Tarrytown, N.Y. “That’s not the business that I think most of us want to be in.”“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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“Let’s bring the F.D.A. back to what its mission is, and its mission is to make sure that drugs can be labeled for safe use, and that they’re not snake oil,” said Dr. Gulfo, the former chief executive of MELA Sciences, who wrote a book about his company’s failed efforts to get its skin cancer detection device approved. (The agency eventually approved it for use in 2011.)
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They have also been prodding the agency to fill an estimated 1,000 staff vacancies so that decisions can be made on more quickly. But that is apparently delayed because the president ordered an across-the-board hiring freeze.
“The only way you would make it shorter is you staff up,” said Michael Gilman, an entrepreneur who has founded several biotech companies. “You certainly don’t do it by slashing staff. So the logic of the whole thing doesn’t compute for me.”
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