Biden Administration

The new COVID-19 stimulus package is now law. As discussed herein, it provides some employers an incentive to extend COVID-19 related FFCRA leave benefits through Q1 2021.

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well, which we cover in this part 3 of our year-end post.

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over the past year. We’ll also begin looking forward into 2021 and the agency’s transition to an incoming Biden Administration.

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political pressure, and that effectively ensuring the public health requires a balance between safety and effectiveness and patient access to medical products. As we look ahead, we eagerly anticipate how FDA will protect and promote public health in a Biden administration. In this post we’ll explore the FDA’s device law and policy activities from 2020.

With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.

Read about the Massachusetts congressional delegation to the 117th Congress, their current and potential committee assignments, and possible policy implications.

Read about the post-election impact on international trade matters and the incoming administration's influence on the Committee on Foreign Investments in the U.S. (CFIUS).

Read about how the administration of President-Elect Joe Biden could shape clean tech, energy, and environmental policy in a divided government.