By Emily Cox
President Donald Trump’s hiring freeze, new regulations policy, and uncertainty surrounding his pick for FDA commissioner have had a negative impact on the FDA’s ability to perform at the rate Trump promised during his candidacy, Vox reports.
While a hiring freeze for the federal government is standard for new presidents, it’s difficult to speed up the review process without additional personnel.
However, his executive order requiring two regulations be cut each one a new one is introduced was far more disruptive than the hiring freeze as there are little provisions for how this measure would be implemented.
Trump’s promise to cut FDA regulations by 75 to 80 percent has introduced an unprecedented amount of uncertainty as to how the agency will continue to fulfill its function in keeping the general public’s food and drugs safe.
According to CNBC and Moneycontrol.com, Trump is expected to name the new FDA commissioner in the next week or two, but a couple of his candidates would be a massive departure from tradition. If Jim O’Neill or Balaji Srinivasan were to become commissioner, they would be the first ones without an MD or a PhD degree since the 1950s. It is uncertain how either of these candidates would fit into the framework of the FDA. O’Neill is a Silicon Valley investor who has indicated that the FDA shouldn’t have to prove that drugs work before they are approved – only that they are safe.
“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” O’Neill said. “Let’s prove efficacy after they’ve been legalized.”
Srinivasan, another Silicon Valley entrepreneur, has suggested that the U.S. would be better off if the FDA operated as a “Yelp for Drugs.”
Between the hiring freeze, drastic regulatory changes, and uncertainty regarding some of the FDA’s potential commissioners, Trump’s actions are bogging down the FDA according to Josh Sharfstean, former deputy commissioner of the FDA.
“Having uncertainty on three fronts at once is especially difficult, said Sharfstean. “People spend time worrying instead of doing their work. They spend time planning for different contingencies that may never happen.”
Researchers who study the FDA claim it’s already the fastest drug regulatory agency in the world and Trump’s actions regarding the agency could prove to be dangerous to public health.