HSCA Offers Policy Recommendations to Speed the Approval of Abbreviated New Drug Applications (ANDAs) and Increase Competition in the Generic Drug Marketplace
The Healthcare Supply Chain Association (HSCA) recentlysent a letter to the U.S. Food and Drug Administration (FDA) urging timely implementation of the remaining provisions of the Generic Drug User Fee Amendment (GDUFA). HSCA notes in the letter that GDUFA is vital to the safety, efficacy and affordability of the generic drug market, the healthcare supply chain and patients, and calls on the agency to improve the approval process for the growing backlog of Abbreviated New Drug Applications (ANDAs) to increase competition in the marketplace.
“While we appreciate the work FDA has completed on GDUFA, the growing backlog of new drug applications is creating barriers to affordable and effective treatments for patients and hospitals,” said HSCA President Curtis Rooney. “We want to ensure the primary objectives of GDUFA—improved access, transparency and safety—are accomplished in a timely manner so that generic drugs can continue delivering savings across the entire healthcare supply chain.”
In its letter, HSCA outlined the following recommendations to FDA to help safely expedite approvals and increase agency transparency:
FDA should issue Target Action Dates (TADs) for allbacklog ANDAs;
FDA should post the number of all ANDAs submitted as well as current backlog numbers on its website;
FDA should fast-track potential generic drugs into markets where high drug prices result from manufacturers taking unfair advantage of shortages or market domination.