President Trump promised to review the Food and Drug Administration could make major changes, including steps to accelerate the approval process of new prescription drugs, setting up a shock with critics who say its push for the Deregulation could 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.
If the most important proposals are adopted, many would require a law of Congress to reverse decades of consumer policy and protection dating back to the 1960s. Congress has strengthened drug approvals after a global crisis on thalidomide, which has caused Severe congenital malformations in babies whose mothers had taken the medication during pregnancy. Since then, the FDA is now regarded as the world's leading food safety and pharmaceutical safety agency
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.
Everyone depends on the agency, from drugs in our medicine cabinet to food on our dinner table, to our blood supplies, "said Dr. David Kessler, FDA Commissioner during the presidencies of George HW Bush and Bill Clinton. "We are the envy of the world because our honey is our honey, our food is not filled with pesticides, our medicines work."
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.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.
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 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.”
Drug industry leaders say that they want the F.D.A. to be more open to allowing new kinds of clinical trials, and that it needs to become more nimble in keeping up with the breathtaking pace of medical advances. They have also been prodding the agency to fill an estimated 1,000 staff vacancies so that decisions can be made more quickly. But that is apparently delayed because the president ordered an across-the-board hiring freeze.
Companies have been required to prove that their drugs have been working since 1962.
The laws require companies to rigorously test their products, performing them through a clinical trials gantlet whose results are then reviewed by the FDA. Ninety percent of the drugs that go into 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
“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.
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 will reduce the regulations to a level that no one has ever seen before, and we will have tremendous protection for the people."
