Nathan Brown Quoted in Medtech Insight on Key Differences Between Trump and Biden on FDA Regulations
Contact:
Medtech Insight has quoted Akin Gump health care and life sciences partner Nathan Brown in the article “US Election 2020: What Does a Trump or Biden Win Mean for FDA Regulations?”
Brown said he thinks the two candidates have similar policy goals with respect to the Food and Drug Administration (FDA), though the path each would take to get there is likely to differ. “To me, the key difference would be the degree to which each administration would use the FDA to achieve their broader goals,” he said.
If President Trump is reelected, Brown said he expects the administration to continue pushing the FDA to achieve the goals laid out in the “Buy American” executive order earlier this year, which calls for federal agencies to prioritize buying American-made medical products. He also thinks the coronavirus pandemic will continue to be the dominant issue next year.
While either a Trump or Biden administration would prioritize issues such as on-shoring of manufacturing and access to affordable medicine, their approaches would likely be very different, according to Brown.
“I would expect a Trump administration to enlist the FDA in that effort in a much more overt manner than Biden would, who would be more mindful of the FDA's traditional role and its limited application to industrial policy,” Brown said. “I think both, for instance, would push for lower drug prices, but there may be a difference in exactly how they would insert the FDA into that broader policy effort.”
Other areas that Brown addressed included President Trump’s prior argument that product sponsors should pay 100 percent of the cost for premarket reviews, the rift that exists regarding laboratory-developed test regulations between the Department of Health and Human Services and the FDA, and whether the FDA will prioritize access to health care products for desperate populations and diversity in clinical trials. Given the lack of focus on policy differences, Brown said it is difficult to figure out where the candidates plan to take medtech regulations if they win.
