Here is a round-up of comments and actions from President Donald Trump that look like affecting pharmaceutical regulations in the US and the Food and Drugs Administration (FDA).
- With an executive order, Trump called for a substantial overhaul of FDA regulations.
- Trump informed pharmaceutical company CEOs that he will be cutting regulations at a level no one has ever seen before.
- Between 75% and 80% of all FDA regulations will be eliminated.
- The EO requires all government agencies, apparently including FDA, to eliminate two regulations for every new regulation instituted (so called “one in, two out” plan).
- This plan appears to also cover FDA guidance documents.
- Trump said that the drug approval process will be streamlined so that the time to get a drug approved is faster.
But there is a massive lack of clarity about what this overhaul will look like and it throws up more issues and questions than answers. For example:
Eliminating FDA guidance may not be so smart given that companies rely on it to understand how FDA interprets legislation and to ensure the companies comply with the regulations
How will the “one in, two out” plan work? When a new regulation or guidance document is introduced, will two in the same area be eliminated, or could FDA remove two regulations or guidance documents from an unrelated area?
What will happen to draft guidelines or regulations that are currently in the making?
To read highlights from the President’s listening session with pharmaceutical industry leaders, please click here.