Food and Drug Regulatory Trends and Developments: Navigating Implications for the Year Ahead
The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.
FDA has issued guidances and templates to help industry develop substantive emergency use authorization requests with sufficient information to enable effective and streamlined review, exercised enforcement discretion where it deemed the benefits outweighed the risks, and waived regulatory requirements to help get products to market quickly. And FDA has indicated its willingness to “course correct” when evidence has demonstrated that the agency’s flexibility resulted in more harm than good. FDA is also providing significant trial design assistance and wading into thorny ethical issues in connection with the race to develop a vaccine.
There may be long-lasting effects from the pandemic even after the immediate threat abates. Going forward, companies may opt to reevaluate their supply chains, taking into consideration the shortages seen during the pandemic attributable in part to the country’s reliance on foreign sources of API, finished drugs, and devices like N95 masks. FDA has also shown willingness to use real world evidence as it evaluates COVID-19 therapeutics and has welcomed digital health applications that enable remote monitoring of clinical trial subjects and remote evaluation and treatment of sick patients. Certain changes may remain after the pandemic subsides and the current public health emergency declaration is lifted.
In this webcast, Beth P. Weinman (Ropes & Gray LLP) and Jennifer Mallory (Nelson Mullins Riley & Scarborough LLP) will address the above topics as they provide an overview of the impact of COVID-19 on the FDA regulatory environment.
Nelson Mullins Riley & Scarborough LLP
Ropes & Gray LLP
Pandemic Impact on Agency Priorities
Heading into 2020
- E-Cigarettes and Teen Vaping
- CBD and Cannabis
- Reducing Drug Prices
- Spurring Generic Drug Development and Approvals
- Supply Chain
Who Should Attend:
- Drug and Device Manufacturers
- Compliance Officers
- Legal Advisors
- Operations Managers
- Senior Management
Jennifer Mallory is a partner at Nelson Mullins Riley & Scarborough’s flagship office in Columbia, South Carolina where she focuses her practice in the areas of food, drug, and device law as well as clinical research, bioethics, and business and intellectual property litigation. She has served as a member of several boards including the Medical University of South Carolina Institutional Review Board, S.C. Bar Board of Governors, and the Rutland Ethics Alliance. Mallory holds graduate certificates in Clinical Research and the Law and in FDA Regulation and Liability—both from Seton Hall University School of Law. She earned her JD from Washington and Lee University School of Law and her BA from the University of South Carolina, cum laude.
Jennifer Mallory is a partner at Nelson Mullins Riley & Scarborough’s flagship office in Columbia, South Carolina where she focuses …
Beth Weinman focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and dietary supplements. Beth provides counseling on issues related to off-label promotion, good manufacturing practices, good clinical practices, compounding, product recalls and withdrawals, False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations.
Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18.
Before starting at FDA, Beth was an associate in the litigation department of a large New York law firm.
Beth Weinman focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and dietary supplements. …
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Method of Presentation:
On-demand Webcast (CLE)
General knowledge of food and drug regulations
NY Category of CLE Credit:
Areas of Professional Practice
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About Nelson Mullins Riley & Scarborough LLP
Nelson Mullins is an AmLaw 100 firm serving clients in more than 100 diversified practice areas. From a firm of one attorney in 1897 to 800+ attorneys, policy advisors, and professionals in 11 states and the District of Columbia today, we represent corporate and individual clients in a wide variety of areas, including: food/drug/device law, regulatory, healthcare, litigation, intellectual property, real estate capital markets, corporate, technology, banking, e-discovery, economic development, securities, finance, tax, estate planning, governmental relations, environmental, real estate, labor and employment, privacy and security, and white collar crime. Nelson Mullins’ clients range from Fortune 500 companies to private equity and venture funds and portfolio companies to emerging growth companies and start-ups.
About Ropes & Gray LLP
Ropes & Gray is a leading global law firm with 11 offices located around the world. Our Washington, D.C.-based FDA regulatory team includes seasoned lawyers knowledgeable in all areas of FDA regulation. The team’s varied backgrounds bring a breadth of perspectives to the practice which includes attorneys who have worked at the FDA, as in-house counsel at life sciences companies and as key policy advisors in Congress.
As part of our multidisciplinary life sciences group, our FDA regulatory team has a broad view of the commercial and regulatory forces affecting life sciences companies. In addition to traditional regulatory counseling and administrative litigation, we advise clients on corporate and transactional matters, government enforcement investigations, compliance program design and implementation, and FDA-related intellectual property analyses and litigation.