The FDA has published a list of off-patent branded drugs without approved generics, and has committed to speeding up reviews of generic drug applications where competition is limited—actions the agency said would increase competition in the market for prescription drugs, helping bring lower-cost treatments to market.
The new list includes branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve an Abbreviated New Drug Application (ANDA). The FDA said it intends to accelerate the review of any generic drug application for a product on the list to ensure that they come to market as quickly as possible.
The FDA said it will ensure continued transparency around drug categories where increased competition could provide significant benefit to patients, by updating and refining the list periodically.
In addition, the agency has changed its policy on reviewing generic drug applications, saying it will expedite reviews of ANDAs until three generics are approved for a given drug product. The FDA cited data showing that “significant” price reductions occur when multiple generics reach the market.
FDA Commissioner Scott Gottlieb, M.D., identified changes to the agency’s process of reviewing generic drugs in his first remarks to agency staffers in May: “We also need to take steps to make sure the generic drug process isn’t being inappropriately gamed to delay competition and disadvantage consumers.” He added, “I hope to have much more to say on this topic in the coming weeks.”
The FDA’s actions come a few weeks before a scheduled July 18 public meeting to solicit input on the use of FDA rules to impede generic access, including regulations related to generic drug approvals.
“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,” Dr. Gottlieb added.
Those additional actions, he said, would be rolled out “in the near future” and will include public communication by the agency.
“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,” Dr. Gottlieb added.