FDA Plan to Boost Drug Competition Includes Expedited Generic Approval Pathway

As part of its new Drug Competition Action Plan, the FDA has announced it will seek to spur innovation by allowing for accelerated approvals of generic drugs without competitors. It also published a list of drugs without approved generics that could be eligible for this expedited review process.

Containing the cost of prescription drugs by encouraging competition has been a primary focus of FDA commissioner Scott Gottlieb, MD, during his first months in the role. The announcement today follows up on his stated plans to formulate a Drug Competition Action Plan, which he revealed in a Senate hearing in May.

The most significant change concerns the abbreviated new drug application process for generic drugs. According to a new policy manual effective immediately, applications for generic products may receive expedited review if there are no blocking patents or exclusivities and if the reference drug has less than 3 approved generics. Proposed generics filing with a Paragraph IV certification—indicating there is a patent that the generic manufacturer says it has not infringed on—may undergo expedited review if the application becomes eligible during the review period and if there is no other generic for the reference drug.

These determinations will be made by the Office of Generic Drugs Division of Project Management staff, who have been responsible for prioritizing approvals since the FDA changed its “first-in, first-reviewed” policy in 2006. Other considerations that may warrant expedited review include submissions related to drug shortages, public health emergencies, or “sole source” drug products.

According to the FDA’s announcement, the revision of the expedited review process regulations is “based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.” Gottlieb described these steps as part of the agency’s broader efforts to ensure patient access to needed drugs.

“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,” he said in the statement.

Another development touted in the press release was the publication of a list of drug products without generics that have no patent or exclusivity barriers. This list will serve as a guide of suggestions for drug manufacturers seeking to receive an expedited review for a potential new generic. The FDA plans to update the list every 6 months in the interest of increased transparency and, ideally, heightened competition.

These efforts come just days after Gottlieb declared in a blog post that the agency would hold a public meeting on July 18 in order to gather feedback on whether its current generic approval policies are helpful or are in fact impeding competition and access to affordable drugs.

In the new press release, the agency hinted that further components of the Drug Competition Action Plan will be unveiled in the near future.

“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,” said Gottlieb in the statement.