Experts to provide insight on FDA under Biden during RAPS virtual event

As the COVID-19 pandemic continues, and the virus’s highly transmissible delta variant fuels a spike in new cases, hospitalizations and deaths, the work of the US Food and Drug Administration (FDA) has arguably never been more critical. The agency made big news again this week as it took the highly anticipated step of granting full approval to the Pfizer-BioNTech coronavirus vaccine.

Beyond the front-page headlines, what are the other important developments at FDA regulatory professionals need to be tracking? What changes ushered in under President Joe Biden’s administration will have the greatest impact on your day-to-day work?

On Thursday, 2 September, RAPS will host a virtual program examining FDA’s actions thus far under the Biden administration, as well as looking at what may be in store for the future. The program will feature presentations and a panel discussion of five experts with decades of experience working for and with FDA, followed by an opportunity for attendees to ask questions.

We caught up with two of the five expert speakers to ask them about FDA, the program, and what attendees can expect. Allison Fulton is a partner with Sheppard Mullin’s Washington, DC, office, leading up the firm’s life sciences and FDA team. Wayne Pines served in senior positions at FDA for 10 years and currently is with APCO Worldwide as a member of the consultancy’s international advisory council and president of healthcare.

The following answers have been lightly edited for clarity and style.

Why should someone attend this virtual event, and what will they get out of it?

Allison Fulton: I think it’s always interesting to reflect on the last administration—and especially the many activities over this last year with COVID—and ask what went right? What went wrong? And how might it change going forward? We hope to explore that in the webcast.

Wayne Pines: Anyone who tracks FDA should attend. This webcast will provide an overview of what has occurred in the past nine months and provide some insights into where FDA seems to be headed on all fronts–regulatory, policy, personnel, and initiatives.

What topics will you be covering during your presentation?

WP: We will cover the Biden administration’s activities to date involving drug and device products, and provide insights into what to expect in future months.

AF: I will be exploring medical device topics, such as the impact of COVID on device approvals, including the significant impact of Emergency Use Authorizations (EUAs) and the backlogs that have been generated as a result. I’ll explore the current state of play for laboratory developed tests (LDTs)—both at the agency and in Congress. We’ll also look at FDA’s continuing efforts to collaborate with industry on digital health. Lastly, remote is the new normal. Whether that’s remote patient care, remote physician access, or remote inspections. I’ll explore how the agency will adapt to a remote environment.

What are some other noteworthy changes or changes we might see in the coming months at FDA under the Biden administration?

WP: The big issues are in the media—vaccines, response to the pandemic, noteworthy drug approvals, personnel. FDA is in the news virtually every day, and our webcast will try to bring together all the issues and developments and look into our crystal ball.

AF: I think we will see a reversal of the Trump administration’s policy on LDTs, announced late in Trump’s term. Under the policy, announced on 19 August 2020, HHS determined that FDA must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. The policy statement is no longer accessible on the HHS website, that I have found, which signals a departure from the policy—although I haven’t seen a formal announcement from HHS under Biden.

What qualities do you think the Biden administration is looking for in someone to serve as FDA commissioner? Why has the administration not yet selected a nominee?

WP: The Biden administration has maintained absolute silence on a commissioner selection. We’ll just have to wait to see who is nominated. They seem to be looking for someone who can manage this regulatory/science agency in the midst of multiple crises, and also drive forward a broader agency involving every agency center. And they need someone who can be confirmed by the senate.

The Biden Administration's FDA: What's Happened and What to Expect will take place 2 September, 1:30 – 4:30 pm EDT. The cost is $300 for RAPS members, $335 for nonmembers.