There are many reasons to be concerned about food and drug safety today. Even with an FDA committed to ensuring our food and drugs are safe and effective, the FDA allows chemicals in our foods that may not be safe and approves prescription drugs for use that have been pulled from the market because they are later found to be unsafe. So what does a Trump FDA look like?
If you believe that the FDA provides a critical function in keeping drugs from going to market until they are shown to be safe and effective, you should be concerned about the FDA’s future. President-elect Trump is considering Jim O’Neill to head the agency, and StatNews reports that O’Neill has made clear that he thinks people should be free to test any drugs they’d like at their own risk. Specifically, O’Neill has proposed that the FDA should not have to establish that a drug works to treat a condition before it approves it, only that it is safe.
While in theory, failing to focus on drug efficacy might sound like a great way to get more drugs to market faster, it risks undercutting our ability to understand the value of particular drugs for particular conditions. Instead of a Consumer Reports-type rating based on scientific evidence, we’ll have customer reviews. But, customer reviews can be manipulated by companies wanting to push a product. And, even when customer reviews are genuine, they may be extremely misleading when it comes to whether a drug works. People’s ability to rate the efficacy of a particular drug is far different from their ability to rate hotels and vacuum cleaners.
O’Neill is a libertarian and billionaire Peter Thiel’s managing director at Mithril Capital Management. He has neither a medical background nor a science background, as you would expect an FDA chief would have. However, O’Neill did work in the U.S. Department of Health and Human Services in 2002, during the George W. Bush administration.
Scott Gottlieb is another person under consideration for the FDA chief post. Scott Walker enlisted Gottlieb as a senior adviser to his presidential campaign.
Here’s more from Just Care:
- Majority of cancer drugs that the FDA has recently approved don’t work
- Drug companies must now report most clinical trial results
- Six tips for keeping drug costs down if you have Medicare