FDA takes first steps in Drug Competition Action Plan for generics
SILVER SPRING, Md. — The Food and Drug Administration has taken the first step in its recently announced effort to bring more generics to market to increase competition. The agency has posted a list of branded drugs that have no listed patents or exclusivities that currently have no approved generics and has instituted a new policy to speed up review of applications for generics of products with limited competition.
"No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require," FDA commissioner Dr. Scott Gottlieb said. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren't used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
In addition to the posted list, the agency also has announced that it will offer expedited review to any generic application for a product on the list to speed up its time-to-market. More broadly, the agency said that it would begin expediting the review of applications for until there are three generics for a given product.
These efforts are part of actions the agency is taking in the lead up to its July 18 public meeting, where it said it intends to solicit input on places where the FDA’s rules are being used to make generics access more difficult.
“I am committed to continuing to pursue additional policy steps, under the FDA's current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” Gottlieb said.
The move drew praise from the generics industry.
“FDA Commissioner Dr. Scott Gottlieb’s swift and decisive action to expand access to safe, effective and affordable generic and biosimilar medicines is of tremendous benefit for our nation’s patients,” Association for Accessible Medicines president and CEO Chip Davis said. “Today’s announcement signals that any serious effort by the Trump Administration and the United States Congress to bring down drug costs for patients must include more affordable generics and biosimilars. AAM looks forward to working with FDA and policymakers on all possible ways to further enhance competition and improve the first-cycle approval rate for generic drug applications.”
The list can be accessed here, and the policies on expediting applications can be accessed here.