Jim Dickinson, Posted in Regulatory and Compliance by MDDI Staff on December 16, 2016
Emerging like the campaign that preceded it as the most unconventional in history, the incoming Trump Administration has many conservatives clambering aboard his train, expecting big changes—including relief for industries regulated by FDA.
For that to come about, much will depend on Trump’s choice for Secretary of HHS, six-term Atlanta-based congressman and orthopedic surgeon Tom Price, who has displayed little interest in the agency other than to unsuccessfully vote against it being given regulatory control over tobacco products.
His main focus is expected to be on repealing and replacing Obamacare, a mission more in keeping with his track record of concentrating on economic issues affecting his fellow physicians and the hospitals they operate in.
A secondary focus will be implementing the new 21st Century Cures Act, which does have a bit to say about FDA and especially about the agency’s treatment of medical devices. Price was among the lopsided 392-26 majority that voted for it in the House.
A strong supporter of “medical innovation,” as he put it then, Price in 2015 voted against the first version of this bill, complaining that it “sets an unacceptable precedent—particularly at a time when so much of our federal budget is already on auto-pilot, increasingly difficult to control and a significant risk to America’s fiscal well-being. I stand ready to work with my colleagues in advancing funding for health care research and to do so in a responsible manner.”
The Cures act will force some awareness of FDA on Price because of its provisions affecting reviews of new devices, drugs, and combination products.