The Biden Administration's FDA: What's Happened and What to Expect

3.0
RAC Credits
Virtual Programs
Thursday, 02 September 2021 (1:30 PM) - Thursday, 02 September 2021 (4:30 PM) Eastern Time (US & Canada)

The Biden administration has brought in new policies and personnel to the federal health care team. The FDA remains in the news every day as it exercises its vast responsibilities over drugs and devices. At the same time, the FDA must restore its reputation, show that it has learned from the pandemic, manage some of the most challenging issues and decisions it has ever faced, and be prepared to effect still further changes.
These developments mean regulatory professionals need to fully understand what’s happened thus far and to anticipate, understand, and comply with what’s coming in the future.
This virtual 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. The experts will explain what we have seen in the first six months of the Biden administration and what to expect going forward in regard to new drug and device development and approvals.

Please note that this workshop will not be recorded.


Pricing Amounts & Deadlines

2 September 2021: Member $300.00 | Nonmember $335.00


Learning Objectives:

The speakers will address questions such as:

  • What has changed at the FDA under Biden that has and will affect what you do every day?
  • How should you plan now for upcoming changes to be ready for developments later in 2021 and in 2022 in drug and device regulation, enforcement, drug pricing and health care innovation?
  • What new guidances are likely to be issued this year and next?
  • What role will HHS and the White House play under Biden?
  • How important are politics in FDA decision-making?
  • What is the agenda for the new CDER director?
  • What are the agendas for the CBER and CDRH directors?
  • What regulatory and policy revisions initiated under the pandemic will continue as we return to normal?
  • What are the key elements from CBER’s five-year plan?
  • How will enforcement under Biden compare to that under the previous administration?
  • What have we learned from recent drug approvals?
  • Will there continue to be extensive use of EUAs?
  • How will the timetables for drug and device approvals change as a result of the experience with vaccine development?
  • What is the plan for virtual inspections and catching up on delayed inspections?
  • Will there be expanded opportunities in regenerative medicine?
  • What will happen in cannabis regulation?
  • What is the current status of regulating software as a medical device?
  • What is the status of harmonization efforts with the EU?
  • What enforcement and policy changes will occur for the advertising and promotion of healthcare products?
  • What will PDUFA 2022 bring in terms of new fees, especially new authorities and new responsibilities for FDA?

Agenda

12:45 PM EST - Attendees logged into the webinar and placed in a virtual waiting room

1:30 - 1:40 PM EST - Welcome & Introduction

  • What are the key issues being faced by FDA in this first year of a new administration?
  • What the key areas where we can expect change?

1:40 - 2:10 PM EST - Biden Administration White House/HHS/FDA Team: New Personnel, New Policies

  • What have been the key personnel changes in Biden’s first year thus far? 
  • Who are the new people and how these personnel changes play out in the long run? 
  • Who exactly is now calling the shots? 
  • What is the relationship between the White House, HHS, FDA & Congress? 

2:10 - 3:00 PM EST - Drug and Device Development and Approval

  • What lessons are we learning from the accelerated approval of Aduhelm for Alzheimer’s disease?
  • What are the most important recent policy developments in the pharmaceutical and medical device development, approval, and regulatory space?
  • How have these developments affected the drug approval process? 
  • Will the relationship between CDER, CBER, CDRH and the Office of Regulatory Affairs change? 
  • What changes have we seen and will we see in the future in these centers/offices?
  • What has been the impact of COVID-19 on drug and device approval?
  • What has been the impact of EUAs, and what does a transition plan look like? 
  • Will we see a shift in CDRH policy regarding diagnostics/LDTs? 
  • Will there be a new normal for remote/virtual FDA interactions?
  • What’s the impact of COVID-19 policies on clinical trials, including use of RWE, and adaptive/decentralized trials?
  • What about new Centers of Excellence? 

3:00 - 3:10 PM EST - Break

3:10 - 4:30 PM EST - Challenges Facing a New Commissioner

  • What can we expect will be the main issues/provisions of PDUFA 22? 
  • How will FDA continue to address the opioid crisis? 
  • What steps may FDA take to increase access to generic drugs and biosimilars?

* Agenda is subject to change.


Who Should Attend?

Anyone who is currently working with the FDA and needs better understanding of the Biden's Administration’s FDA.


Instructors:

Wayne Pines

Wayne Pines is a member of APCO Worldwide’s international advisory council and president of healthcare at APCO Worldwide. He has served as a trusted advisor to US Food and Drug Administration (FDA) leadership for several decades. Pines provides strategic counsel to clients facing crises, or media, legislative, regulatory, or marketing challenges. He served for 10 years in senior positions at FDA, including as chief media spokesman and associate commissioner for public affairs. He has authored or edited a dozen books about FDA and was a co-founder and long-term president of the Alliance for a Stronger FDA.


Andrea Chamblee

Andrea Chamblee is senior counsel in the Washington, DC, office of Wilson Sonsini Goodrich & Rosati, where her practice primarily focuses on representing FDA-regulated companies, small and large alike, in efficiently navigating local and national regulatory requirements for research, clinical trials, manufacturing, commercializing, advertising, and promotion. She brings unique first-hand experience with the development and application of complex regulatory programs across regulated commodities to counsel clients at all stages of the medical product lifecycle.


Kellie Combs

Kellie Combs, partner at Ropes & Gray LLP, provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food, and cosmetics manufacturers, as well as hospitals and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She is a partner in the FDA regulatory practice group and is also a co-chair of the firm’s cross-practice digital health initiative. Combs is currently advising a number of clients on issues related to the COVID-19 pandemic, including the deployment of digital health and telemedicine tools, the manufacture and distribution of personal protective equipment, and the 3D printing of medical devices and components.


Allison Fulton

Allison Fulton is a partner in the Sheppard Mullin, Washington, DC, office. She is the leader of the life sciences and FDA team. Fulton advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food, and cosmetics companies, in matters relating to the development, manufacture and marketing of products regulated by the US Food and Drug Administration (FDA).


Marc Scheineson

Marc Scheineson is a partner in the Alston & Bird, Washington, DC, office where he heads Alston & Bird’s food and drug law team. He advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served as the associate commissioner under then- US Food and Drug Administration (FDA) Commissioner David Kessler, for FDA legislative affairs. Scheineson was involved in many of the agency’s innovations, including prescription drug user fees, debarment, medical device amendments, and nutritional labeling.


Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org