The Top Six Ways Trump’s Policies Will Impact Pharmacies
We're still within the first 100 days of a new administration. What is happening, and what can you expect?
6. FDA reform:
President Trump is in favor of fewer government regulations at every agency, and this theme is expected to extend to the FDA. He issued an executive order calling for two regulations to be cut for every new one that is approved across agencies. In addition, President Trump said at the White House meeting with pharmacy executives, “We have to get rid of a tremendous number of regulations. I know you have some problems where you cannot even think about opening up new plants. You can’t get approval for the plant and then you can’t get approval to make the drugs.”
Fewer FDA regulations would eventually lead to a faster drug approval process and lower drug prices—hopefully driving more patients into pharmacies. “If approvals on a calendar basis were shortened, even by just two years, there are models that the contribution of development time to approval would mean less of a need for price increases and more exclusivity…those two years would reduce the development expenses and then with longer exclusivity, companies can recoup their R&D funds easier,” Joseph Gulfo, MD, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University in New Jersey and one of Trump’s reported candidates for FDA Commissioner, told Regulatory Focus.
However, for pharmacists, it is uncertain what the hands-offgovernment approach might mean for the ongoing implementation of the Drug Quality Security Act (DQSA), related to oversight over drug compounding as well as track-and-trace standards for the drug supply chain, Hoey said.