Perhaps you’ve heard President Trump say he’d like to “loosen” regulations on drugs and devices in the U.S., vowing to streamline the Food and Drug Administration (FDA), the agency that oversees drug and device approval. If you haven’t, or if you have and aren’t sure how these plans might affect you and your family and your health, read on.
The FDA is important to all of our lives. The agency is, according to the New York Times, “the world’s leading watchdog for protecting the safety of food and drugs, a gold standard whose lead other countries often follow.” But Trump wants to lower the barriers to getting these drugs to market, making it easier for drugs to pass approval, which may place consumers’ health at risk. He’s considering two candidates to head the FDA to help him do so: Dr. Scott Gottlieb, a former senior FDA official, and Jim O’Neill, a Silicon Valley investor. Now that Tom Price has been confirmed as the head of the Department of Health and Human Services, Vox reports that the FDA commissioner pick will be next.
Of the two choices, Jim O’Neill’s perspective on drug approvals is alarming to public health groups. O’Neill has said that he doesn’t think that drugs should have to be proven effective in clinical trials before going to market. In a 2014 speech about what he calls “progressive approval” for pharmaceuticals, O’Neill suggested, “Let’s prove efficacy after they’ve been legalized.”
Trump told pharmaceutical leaders in a listening session last month, “We’re going to get rid of a tremendous number of regulations.” (75 to 80 percent of them, if you take his claim at face value that he’d cut them from 9,000 pages to 100 pages).
Read the rest of Trump's plans for the FDA here.