Wade Ackerman is quoted in Medtech Insight regarding the impact of the 2020 presidential election on FDA regulations. Mr. Ackerman says the outcome of the election may have a significant effect on the leadership of U.S. FDA, with either winner bringing marked differences in policies and priorities.
In a note to clients, he outlined some differences medtech stakeholders can expect, saying Trump administration's focus for the FDA over the past year has been dealing with the coronavirus pandemic. The administration has used the agency's emergency use authorization powers to allow new therapeutics, diagnostics and devices onto the market. Stakeholders can expect the agency to stay the course in “prioritizing the pandemic response efforts” as it has pushed out a plethora of emergency guidances and enforcement policies to allow for more regulatory flexibility to tackle the crisis. As in any second-term presidency, he says the country could expect to see changes in political staff and potential changes in the FDA's leadership if Trump is re-elected.
“In fact, FDA and [the Department of Health and Human Services] have already seen a number of recent political staff departures,” he says. “This trend could be especially pronounced next year, given the pace at which staff have been working due to the pandemic, and these transitions could result in some new policies and goals for a second term.”
He also says a second Trump administration will likely continue to focus on the president's “Buy America” Executive Order from August, which calls for federal agencies to prioritize buying American-made medical products. “The implementation and effect of the EO remain to be determined, but look for a second Trump Administration to continue entering into 're-shoring' contracts and to otherwise pursue 'Buy American' policies to strengthen the domestic supply chain for medical products,” he adds.
Mr. Ackerman notes if Biden and Kamala Harris are sworn in, they will have to switch gears from criticizing the federal pandemic response to owning the response. “Expect them to strive to find an appropriate balance: Providing the space and time needed for FDA career staff to do their work, and ensuring the federal government is working as expeditiously as possible toward ending this devastating pandemic,” he says. “A Biden Administration is likely to highlight career scientific staff, in an attempt to rebuild what the former Vice President sees as an erosion of public trust in federal health agencies. Expect a messaging push on this front, along with potential new policies that solidify the roles and voices of career staff within the federal government.”
He says as with any new administration, Biden will put new political appointees at the helm of the FDA and HHS. Once those positions are either filled, the administration will outline its first-term goals which most likely will be topped by a plan for dealing with the COVID-19 crisis. “They will seek input from HHS and the White House, as well as key offices on the Hill, including members of the Senate HELP and the House Energy and Commerce (E&C) Committees, where Sen. Patty Murray, D-WA, and Rep. Frank Pallone, D-NJ, currently serve in Democratic leadership roles, respectively,” says Mr. Ackerman. “Whether Democrats have control of the Senate will inform the Biden Administration's priorities, although FDA leadership usually works closely with members from both sides of the aisle given the agency's public health mission.”
Policy areas that a Biden administration will likely focus on through the FDA include generic and biosimilar competition, LDT reform, and cannabidiol (CBD) rulemaking, he says.
“While the digitalization of FDA-regulated products and activities is happening at a rapid pace, particularly in light of the pandemic, expect a Biden Administration to take a fresh look at these ongoing initiatives,” he adds. “For example, some Democrats on the Hill have raised questions and concerns in the past about FDA's Pre-Cert Pilot, so a Biden Administration may want to put its own mark on these policies heading into the user fee reauthorization in 2022.”
Finally, he says that like Trump, Biden has also campaigned to make the U.S. more self-sufficient in terms of medical products. This is especially important to prevent disruptions to the medical product supply chain in light of the pandemic, and Biden has pledged to increase domestic manufacturing capacity to avoid future shortages of critical goods such as personal protective equipment (PPE). “While release of a comprehensive strategy is pending, likely priorities of a Biden Administration include: Making greater use of authorities under the Defense Production Act (DPA) and Procurement Act of 1949, using Biomedical Advanced Research and Development Authority (BARDA) to make science-based purchasing decisions (including the possible use of compulsory licensing), implementing some form of 'Buy American' requirement for federal drug purchases, enacting tax and other incentives to encourage on-shoring of pharmaceutical manufacturing, establishing requirements for companies to develop plans to address shortages/disruptions, and increasing federal stockpiles, and promoting surge manufacturing capacity,” he adds.
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