As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in 2022 related to FDA and
Denise Esposito is the co-chair of Covington & Burling’s global Food, Drug, and Device Practice Group. Denise has more than 25 years of experience in the life sciences industry, including senior leadership roles within U.S. Food and Drug Administration (FDA), as the general counsel of a publicly traded biotechnology company, and as a partner in private practice. She provides strategic, policy, and regulatory advice to biotechnology, pharmaceutical, and medical device clients, with a focus on matters that involve navigation of FDA and the complex political and policy challenges that FDA-regulated companies are facing. Denise’s practice includes advising clients on marketing authorization strategies, expedited approval programs, life cycle management, and the promotion of medical products. She works with clients on FDA engagement strategies, formal and informal FDA dispute resolution, and crisis management around FDA actions.
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top strategic priority for the FDA.” FDA opened a docket for public comments on the Framework through February 5, 2019.
The Framework focuses in particular on the use of RWE to support regulatory decisions about effectiveness. The agency outlines three considerations that will guide its overall RWE Program and inform the agency’s assessment of individual drug applications. The Framework also offers background on the agency’s previous use and current initiatives with respect to RWE and related topics, such as innovative clinical trial designs. This blog post provides an overview of FDA’s proposal and highlights a few initial takeaways noted by Covington’s Digital Health team.…