FDA to Expedite Generic Drug Approvals

Today, the FDA announced it would implement 2 steps to increase the competition of prescription drugs and allow for easier entry of generic drugs.

The FDA has published a list of branded drugs that are off-patent, off-exclusivity, and do not have approved generics. The agency has also enacted a novel policy to expedite the review of generic applications for drugs with limited competition, according to a press release.

These new steps are the first taken under the Drug Competition Action Plan, which was announced by FDA Commissioner Scott Gottlieb, MD, in May 2017.

“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 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.”

To facilitate the development of generic drugs, the agency has posted the list of drugs with no abbreviated new drug application and will expedite generics of branded drugs on the list, according to the release. These actions are to ensure that the drugs are brought to market as quickly as possible.

The FDA reported that the list will be updated to provide continuous transparency for drug categories that can benefit from increased competition.

The agency will also change its policy on how it reviews generic drug applications. Under the new rule, applications will be expedited until there are 3 approved generics from a drug, according to the release. This policy is being revised based on data that indicates multiple generics for 1 branded drug elicits patient savings.

These steps closely follow an announcement of a public meeting to determine how the FDA’s rules may hinder generic approvals and how they can be improved, according to the release.

In the announcement, Dr Gottlieb reports that the healthcare system has saved more than $1.67 trillion over the past decade through the use of generic drugs. The agency understands that sometimes FDA regulations are sometimes harnessed in a way to delay generic approvals, and they are actively looking to revise the rules, according to the release.

The 2 steps taken today are intended to develop a solution to this issue. The FDA plans to seek additional ways to improve access to lower-cost generic drugs to reduce out-of-pocket costs for patients.

“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 concluded.