On September 17, the U.S. Senate Special Committee on Aging will convene a hearing to address concerns over the safety and reliability of foreign-manufactured generic drugs. Chairman Rick Scott and Ranking Member Kirsten Gillibrand will lead the session, titled “Prescription for Trouble: Drug Safety, Supply Chains, and the Risk to Aging Americans.” The committee aims to examine how quality issues in imported generics, especially those produced in China and India, pose risks to public health and national security.
The hearing will highlight how failures in drug quality can have severe consequences for older Americans. According to the committee announcement, "The hearing will examine the serious threats posed by quality issues in foreign-manufactured generic drugs, as well as the risks that vulnerable pharmaceutical supply chains present to both public health and national security." The focus will be on ways these problems disproportionately affect aging populations.
Expert witnesses scheduled to testify include Peter Baker, former FDA inspector and president of Live Oak Quality Assurance; George Ball, PhD, associate professor at Indiana University’s Kelley School of Business; Brandon Daniels, CEO of Exiger; and Ronald T. Piervincenzi, PhD, CEO of U.S. Pharmacopeia.
Testimony is expected to address calls for stronger oversight from the Food and Drug Administration (FDA), with suggestions such as increased testing standards and equal inspection requirements for foreign manufacturers. The committee also plans to discuss strategies for bringing production of essential medications back to the United States.
The event is open to the public at Hart Senate Office Building SH-216 at 3:30 PM Eastern Time. A live broadcast will be available online.
"The hearing will also spotlight tragic cases of adverse events linked to substandard generics and highlight solutions to protect the health and safety of aging Americans," according to organizers.
