On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition. The Order directs the Food and Drug Administration (“FDA”) to make more transparent the process for approving generic drugs and biosimilars, including clarifying the standards for interchangeability of biological products; and to develop educational materials to help providers, patients, and caregivers better understand biosimilars and interchangeable products. There are instructions to the U.S. Federal Trade Commission (“FTC”) to call out misleading and deceptive statements made about the safety and effectiveness of generics and biosimilars, and a controversial proposal to issue rules that ban many patent settlements that delay the market entry of generic drugs or biosimilars. There are instructions to the U.S. Department of Health and Human Services (“HHS”) to support the market entry of lower-cost generic drugs and biosimilars by helping product developers obtain brand-drug samples pursuant to the CREATES Act of 2019. And there are instructions to the Centers for Medicare and Medicaid Services (“CMS”) to prepare for Medicare and Medicaid coverage of interchangeable biological products, and for payment models to support increased utilization of generic drugs and biosimilars.
For a more in-depth analysis of the Biden Executive Order, please see Goodwin’s client alert prepared by Goodwin’s healthcare experts, Matt Wetzel, Nikhil Sethi, and Roger Cohen; and “Biden Executive Order Calls for Heightened Antitrust Scrutiny,” prepared by Goodwin’s antitrust experts Chris Holding, Paul Jin, Andrew Lacy, and Arman Oruc.
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