Expanded Access: Analysis of the Latest Developments – Webinar Recording/Transcript
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Expanded access — compassionate use of drugs prior to FDA approval — is getting another big push by the agency. This is a huge opportunity for the most seriously ill patients.
The FDA has taken extraordinary measures over the past five years to increase use of expanded access but with little resulting change. Congress addressed the issue in 2018 by enacting Right to Try legislation but the new expanded access pathway has hardly been used. Last year the FDA announced Project Facilitate — a dedicated FDA oncology staff helping physicians with expanded access requests. And with the current COVID-19 pandemic expanded access is getting even more momentum… while numerous ethical and practical issues have been raised again, spurring more talk than access.
While expanded access is vital in the abstract, in practice, it has multiple barriers that prevent patients with a serious disease or condition from getting an investigational drug or biologic. Lives are in the balance and patients will benefit when you understand — and can navigate — the landscape.
This presentation will explore the expanded access terrain, provide an update on current regulatory changes and address possible policy solutions to this treatment dilemma. By understanding current law and regulations affecting expanded access as well as policy choices facing the FDA and Congress as they try to encourage use, you will be able to ensure an increased number of patients take part.
Lisa Dwyer, Preeya Noronha Pinto and David Farber are partners with expanded access expertise in the FDA/Life Sciences practice at King & Spalding, based in Washington, DC.
- The existing legal and regulatory landscape driving expanded access, including 21 U.S.C. 360bbb-0 (Section 561b of the Food, Drug and Cosmetic Act)
- Recent congressional changes and how the FDA is implementing those changes, such as the recent FDA Proposed Rule on Annual Summary Reporting Requirements under the Right to Try Act, found at 85 Fed. Reg. 44803 (July 24, 2020)
- The FDA’s voluntary efforts to increase use of expanded access, including the new Project Facilitate
- Arguments in favor of and opposed to Right to Try, including whether it will help or harm patient access, if anyone is using the pathway, and whether mainstream manufacturers would ever want to use the pathway.
- Policy considerations underlying the expanded access debate, such as monitoring and tracking of expanded access outcomes and adverse events.
The use of expanded access data as real-world evidence, including the use of expanded access outcomes results in the NDA review process or for coverage and reimbursement purposes.
Expanded access is evolving. Successfully navigate the new landscape.
Meet Your Presenters
Lisa Dwyer is a partner in the FDA/Life Sciences practice at King & Spalding, based in Washington, DC. Before joining K&S, Ms. Dwyer served as a senior policy advisor in the FDA Commissioner’s office and as the deputy chief of staff to the Commissioner of Food and Drugs. She is a subject matter expert on expanded access, and regularly presents on the topic.
Preeya Noronha Pinto is a partner in the FDA/Life Sciences practice at King & Spalding, based in Washington, DC. Earlier in her career, Ms. Pinto served as an attorney in the Justice Department and the Department of Health and Human Services, rising to become the acting general counsel of the department, where she provided legal advice to both FDA and CMS. She regularly speaks on expanded access issues.
David Farber is a partner in the FDA/Life Sciences practice at King & Spalding, based in Washington, DC. He has presented across the country on expanded access issues, including debating the topic on National Public Radio’s 1A.
Who Will Benefit
- Expanded Access Professionals
- Regulatory Experts
- Market Access Professionals
- Clinical Trial Design Professionals
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Sept. 10, 2020