WASHINGTON — Following nearly 2 years under the leadership of Commissioner Scott Gottlieb, MD, the FDA and its Acting Commissioner Norman E. Sharpless, MD, will continue to enact Gottlieb’s action plans in 2019 and keep an eye on potential challenges as the country moves toward the 2020 presidential election, a speaker said here.
Gottlieb resigned from his FDA position at the end of March, ending a term that saw the agency approve its first gene therapy, digital medicine initiative and digital therapeutic, Nancy Bradish Myers, Esq., of Catalyst Healthcare Consulting, said at the Rising Leaders Conference on Healthcare Policy.
Sharpless will likely continue to implement and support action plans put into place by Gottlieb in 2019, such as the Drug Competition Action Plan and Medical Device Safety Action Plan, and continue to ensure the role of the FDA in supporting innovation, efficacy and safety, Myers said.
She noted that prior to his role as acting commissioner, Sharpless’ personal priorities emphasized modernization of clinical trials, use of big data for research, the importance of biomarkers in medicine and reduction of smoking and vaping rates in children.
“In his role, he wants to focus on the continued use of expedited pathways [and] improve the efficiency of new product reviews. He wants to put out new guidance and transparency for the development of cell and gene therapies, and he wants to continue the implementation of the biosimilars action plan,” Myers said.
However, the role of acting FDA commissioner “tends to be that of a caretaker,” and driving new initiatives may be difficult until he, or another candidate, is confirmed as permanent commissioner, Myers said.
With energy and focus turning to the 2020 presidential election, the FDA may be left without a permanent commissioner until after the election, as President Donald J. Trump may not want to nominate and convince the Senate to confirm a new commissioner, Myers said.
Trump is supporting a new Florida bill that would authorize the state to import cheaper drugs for Medicaid, corrections and other state programs. This puts pressure on HHS Secretary Alex Azar to require the FDA to take steps to permit the importation of drugs. Any safety crisis linked to imported drugs could reflect poorly on the FDA, Myers said.
Trade wars with China, which, along with India, supplies 80% of active pharmaceutical ingredients in United States-branded pharmaceutics and OTC drugs, could result in higher prices or potential shortages, she said.
“The FDA could be surprised by political dynamics, global events [and] staffing changes ... [so] the crystal ball is always a little bit unclear,” Myers said. – by Robert Linnehan
Myers NB. FDA in the post-Gottlieb Era. Presented at: Rising Leaders Conference on Healthcare Policy; May 21-22, 2019; Washington.
Disclosure: Myers reports no relevant financial disclosures.