As part of an overall plan to increase competition and lower drug prices, the U.S. Food and Drug Administration (FDA) will take steps to bring more generic drugs to market, including publishing a list of off-patent branded drugs without approved generics and implementing a new policy to expedite the review of generic products.
These actions are part of the agency’s Drug Competition Action Plan, which was announced 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,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency. “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.”
The goal of the recent actions is to encourage generic drug development for off-patent, non-exclusive branded drugs with no approved biosimilars and increase competition among pharmaceutical manufacturers by accelerating the review and approval of generic drug applications until there are three approved generics for a given product. Data indicate that consumers see price reductions when there are multiple FDA-approved generics available, the agency explained.
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.”
The agency plans to release further steps of the Drug Competition Action Plan in the near future, and will hold a public meeting July 18 to solicit input on areas where the FDA’s standards related to generic drug approvals may be creating obstacles to access.
Source: FDA press release, June 27, 2017.