Healthcare Supply Chain Assoc. Applauds FDA Decision

WASHINGTON, D.C. — Healthcare Supply Chain Assoc. (HSCA) President and CEO Todd Ebert released the following statement about the U.S. Food and Drug Administration’s (FDA) decision to begin prioritizing abbreviated new drug applications for generic drugs with only one manufacturer, sometimes known as ‘sole-source’ products:

“We applaud the FDA for taking this important first step to expand patient access to critical generic medications. Expediting the review and approval process for generic drugs with only one manufacturer will help increase competition in the market, mitigate generic drug price spikes, and alleviate future drug shortages.

“The Healthcare Supply Chain Assoc. and our member GPOs have a unique line of sight into the causes of generic price spikes, and we are committed to reducing costs and increasing competition and innovation in the market,” he went on. “We have worked with Congress, FDA, and industry stakeholders to adopt practical solutions, including review prioritization, to help address generic price spikes.

“While the FDA decision to authorize expedited review of sole-source product applications will help foster competition in the generic drug market, there is more to be done to ensure generic medications are accessible and affordable to healthcare providers and patients who rely on them,” Ebert added. “We encourage Congress and FDA to prioritize review of generic drugs with two or fewer manufacturers, or where a price spike has already occurred, particularly in the generic-injectable market.”