Production & Manufacturing

FDA takes key steps under new drug competition action plan

PBR Staff Writer Published 29 June 2017

The US Food and Drug Administration (FDA) is taking two new key steps to increase competition in the market for prescription drugs and support entry of lower-cost alternatives.

The regulatory body has unveiled a list of off-patent and off-exclusivity branded drugs without approved generics, as well as launched a new policy to speed up the assessment of policy to expedite the review of generic drug applications where competition is limited.

FDA has taken these measures as part of its drug competition action plan.

To promote generic drug development, the agency has published a list of branded drugs that have no listed patents or exclusivities, as well as products yet to be approved.

FDA is also planning to accelerate the review of any generic drug application for a product, enabling to launch the products within a short time in the market.

It will speed up the assessment of generic drug applications until there are three approved generics for a given drug product.

The FDA will revise the policy based on data, which will help consumers to check multiple FDA-approved generics with low costs.

The regulator said that it will continue to refine and update the list periodically to ensure continued transparency around drug categories, which will benefit patients.

FDA Commissioner Scott Gottlieb Scott Gottlieb said: “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.

“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.”

Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.