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The November Election and Implications at the FDA: Key Issues to Watch

October 28, 2020, Covington Alert

The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate also will affect FDA’s work, as the party in control of the upper chamber directs its legislative and oversight agenda. Here are a few key issues to watch, depending on how the election turns out.

Trump Administration

Continued Focus on COVID-19 Countermeasures: Given the significance of the COVID-19 pandemic, the Trump Administration has been focused on providing medical countermeasures to help detect, treat, and prevent the virus. To that end, FDA has authorized therapeutics, diagnostics, and devices for emergency use during the pandemic and has issued numerous guidance documents and enforcement policies to advance the response. Expect the Trump Administration to stay the course in prioritizing pandemic response efforts, particularly with regard to the development of safe and effective COVID-19 vaccines.

Personnel Changes: As in any second term, expect to see some changes in the political staff and potentially leadership at FDA and the U.S. Health and Human Services (HHS). In fact, FDA and HHS have already seen a number of recent political staff departures. 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.

Supply Chain/“Buy American”: Expect a Trump Administration to continue its focus on what President Trump has referred to as his “Buy American” Executive Order (EO), which he signed in August 2020. The EO calls upon federal agencies to purchase “essential medicines” and other medical products made in the U.S. This EO is not self-executing, but rather directs FDA to determine which medicines qualify as “essential” by the end of this month; the EO also provides for a number of exemptions based on cost, availability, and the “public interest,” and does not apply to the Medicare program. 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. 

Biden Administration

In the event of a Biden Administration, it will first be important to consider which policies the Trump Administration may issue before leaving office in January. Given the current focus on COVID-19, we may see less last-minute policymaking as compared to the waning days of the Obama Administration, when FDA issued a host of policies before President Trump took office (e.g., a “white paper” on the regulation of Lab Developed Tests (LDTs), guidance addressing communication with payors and communications consistent with labeling, and guidance on several biosimilar and biological product issues). That said, the Trump Administration may try to advance some traditionally Republican-leaning policies in its final days, such as policies around federal preemption and reducing/eliminating regulations and regulatory burdens.

FDA Scientific Decision-making: We have seen both Vice President Biden and Senator Harris express concerns about allegations of political interference with FDA’s decision-making. On January 20th, then-President Biden and then-Vice President Harris will have to switch from being critics of the federal response to being responsible for it. 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. 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. 

Policy Priorities: As with any new administration, a Biden Administration will place new political leadership at HHS and FDA, both in roles that require Senate confirmation and roles that do not. Once these positions start to be filled, expect the new team at FDA to deliberate about the Administration’s first-term goals. Of course, the COVID-19 response will be a top priority, but FDA’s political leadership will set in motion a regulatory policy agenda beyond the pandemic. 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. 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. As context, during the first year of the Obama Administration, the new FDA political leadership worked closely with the Hill to advance a range of priorities, such as new authorities to handle increasing globalization, food safety, agency transparency, and tobacco control. Expect a Biden Administration to set priorities in a similar manner in the coming months. Areas of focus could include generic and biosimilar competition, LDTs (e.g., reversing the current Administration’s recent policy change), dietary supplement (DSHEA) or cosmetic regulatory reforms, and cannabidiol (CBD) rulemaking. Also, with the medical product user fee program negotiations already underway, a Biden Administration will consider whether to add its stamp to the Agency’s current positions in the negotiations, and/or put forward additional legislative proposals for potential inclusion in the reauthorization in 2022, similar to what the Obama Administration did with Title VII of Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012.

Digital and Technology Initiatives: We have seen FDA launch a number of digital and technology initiatives over the last several years, including around use of “real world evidence,” the CDRH Pre-Certification Pilot, a framework for AI/ML-based software, and the New Era of Smarter Food Safety. 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. 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.

Supply Chain/“Buy American”: Vice President Biden also has campaigned on a platform of improving the self-sufficiency of the pharmaceutical and medical product supply chain, and has pledged to increase domestic manufacturing capacity to avoid future shortages of critical goods. 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.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drugs, and Devices practice.

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