Part of the FDA's actions focuses on expediting review of generic applications.
Officials with the US FDA are taking 2 new, steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives, specifically, adopting a new policy to expedite the review of generic drugs applications, and also, publishing a list of off-patent. off-exclusivity branded drugs without approved generics.
The FDA will expedite the review of generic drug applications until there are 3 approved generics for a given drug product. The agency is revising the policy based on data that indicate that consumers see significant price reductions when there are multiple FDA-approved generics available.
To encourage generic drug development, the FDA posted a list of branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application (known as an Abbreviated New Drug Application or ANDA), which includes HIV medications and certain multivitamins, among others. The agency also intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible. The FDA will continue to refine and update the list periodically to ensure continued transparency around drug categories where increased competition has the potential to provide significant benefit to patients.
These actions follow closely the FDA’s announcement of a public meeting to be held on July 18, 2017, to solicit input on places where the FDA’s rules — including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.
These actions are among the first taken under the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb in late May.
“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,” Gottlieb said in a press release. “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.”
FDA Tackles Drug Competition to Improve Patient Access [FDA statement]. Gaithersburg, MD. FDA website. Accessed June 28, 2017 at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm564725.htm