President Biden Issues Executive Order With Provisions To Promote Generic And Biosimilar Competition In The US Economy | Goodwin
On July 9, President Biden issued an executive order regarding competition in various sectors of the U.S. economy, including the healthcare market. Among the 72 initiatives set out in the decree are instructions that entrust various agencies with tasks aimed at promoting competition from generics and biosimilars. The decree directs the Food and Drug Administration (“FDA”) to make the approval process for generic drugs and biosimilars more transparent, in particular by clarifying the standards for interchangeability of biologics; and develop educational materials to help providers, patients and caregivers better understand biosimilars and interchangeable products. There are instructions to the United States Federal Trade Commission (“FTC”) to speak out against deceptive and misleading claims made about the safety and effectiveness of generics and biosimilars, and a controversial proposal to issue rules banning numerous patent regulations that delay the entry into the market of generic or biosimilar drugs. There are instructions to the US Department of Health and Human Services (“HHS”) to support lower cost generic and biosimilar drug market entry by helping product developers obtain branded drug samples in accordance with 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 biologics, and payment models to support increased use of interchangeable biologics. generic drugs and biosimilars.
For a more in-depth analysis of Biden’s Executive Order, please see Goodwin’s Customer Alert prepared by Goodwin health experts Matt Wetzel, Nikhil Sethi and Roger Cohen; and “Biden Executive Order Calls for Enhanced Antitrust Scrutiny,” prepared by Goodwin Antitrust Experts Chris Holding, Paul Jin, Andrew Lacy and Arman Oruc.