IRVING, Texas–(BUSINESS WIRE)–This week, Vizient, Inc. offered expert insights to the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO) on actions that would help increase access to compounded medications and improve the competitive landscape for new generic drugs and biosimilars.
At the FDA’s virtual listening session on drug compounding for hospitals and health systems, held June 24, Katrina Harper, PharmD, MBA, BCPS, clinical pharmacy director for Vizient, shared insights on the primary barriers affecting access to compounded medications and suggested actions the agency could take to clarify compliance issues.
During the session, Harper expressed appreciation for the recent compounding flexibilities the agency has provided during the COVID-19 pandemic and encouraged it to consider retaining certain flexibilities, such as allowing compounding of certain medications before they are placed on FDA’s Drug Shortage list to limit gaps in care. She also articulated the need for the agency to clarify its plans regarding a draft guidance for hospital and health system compounding.
In addition to participating in the FDA event, Vizient today sent comments in response to USPTO’s proposed “PTAB Rules of Practice for Instituting on All Challenged Patent Claims and All Grounds and Eliminating the Presumption at Institution Favoring Petitioner as to Testimonial Evidence”. The proposed rule would alter certain elements of review processes and, as described in Vizient’s comments, potentially disrupt current practices that have helped foster competition by limiting the extent to which invalid patents block access to generic drugs and biosimilars. In the letter, Vizient voiced its support for policies that foster competition, particularly for those drug classifications.
Vizient is the nation’s largest member-driven health care performance improvement company, providing innovative supply chain capabilities, data-driven solutions and expertise that lead to improved patient outcomes and lower costs.
About Vizient, Inc.
Vizient, Inc. provides solutions and services that improve the delivery of high-value care by aligning cost, quality and market performance for more than 50% of the nation’s acute care providers, which includes 95% of the nation’s academic medical centers, and more than 20% of ambulatory providers. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $100 billion in annual purchasing volume, to improve patient outcomes and lower costs. Vizient has earned a World’s Most Ethical Company designation from the Ethisphere Institute every year since its inception. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.