Overview
The Inflation Reduction Act (IRA) was signed into law on August 16, 2022. This groundbreaking law requires that HHS Secretary negotiate pricing for certain Medicare covered drugs and manufacturers pay annual rebates to Medicare for price increases above a set threshold. It additionally eliminates enrollee cost sharing for certain vaccines, sets a $35 limit on enrollee cost sharing for insulin, expands premium tax credit eligibility and amount, and eliminates the eligibility phaseout for households with annual incomes above 400% of the federal poverty level, among other provisions. This session will explore the multi-faceted implications of the IRA on industry and the state of public health, as well as benefits and risks posed by implementing this framework, including impacts on prescription drug affordability, generic drugs, orphan drug exclusivity, differential treatment between small molecules and biologics, and strategy shifting for industry.
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Speakers
Lynn W. Mehler, Partner, Hogan Lovells US LLP
John A. Murphy, Chief Policy Officer Deputy Counsel, Healthcare, Biotechnology Innovation Organization (BIO)
Nancy E. Taylor, Shareholder, Greenberg Traurig, LLP
Eva Temkin, Partner, King & Spalding LLP
LYNN MEHLER serves as co-Head of Hogan Lovells Life Sciences & Health Care industry sector and Head of the Pharmaceuticals and Biotechnology practice, Ms. Mehler advises clients on a range of FDA and DEA regulatory matters. She has worked extensively on the approval processes for new drugs and biologics; on safety issues that include Risk Evaluation and Mitigation Strategies (REMS); and on unique regulatory issues raised during the development and marketing of controlled substances.
JOHN MURPHY serves as the Chief Policy Officer at the Biotechnology Innovation Organization (BIO). BIO is the largest trade association in the world representing biotechnology companies. He
NANCY TAYLOR is Co-Chair of the Health Care & FDA Practice and focuses her practice on health and FDA related matters. She has broad experience working with providers, plans, employers, private equity firms, and FDA regulated companies. She advises clients on health care transactions, health and FDA regulatory, approvals, policy and compliance, and responding to Administration and Congressional investigations and audits. Prior to joining Greenberg Traurig, Nancy served 10 years as Health Policy Director for a Senate Committee and worked on a number of significant health and FDA laws. She also served as CEO of a start-up medical device company, where she obtained eight product clearances, including securing reimbursement coverage for each product.
EVA A. TEMKIN is a partner in the King & Spalding U.S. Food and Drug Administration (FDA) and Life Sciences practice where she provides strategic counsel to clients on a wide variety of FDA regulated products, ranging from biosimilars to cell and gene therapies and complex combination products. Temkin advises pharmaceutical and biotechnology companies at every stage of product development and life-cycle, from data generation (including clinical investigations and real-world evidence) to application submissions, exclusivity matters, and dispute resolution. Before joining King & Spalding, Eva acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars, where she oversaw regulatory policy related to biosimilars and other therapeutic biologics. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to FDA’s biomedical product centers on a wide range of drug, biologic, and combination product issues.Virtual Learning FAQ
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