The US Food and Drug Administration (FDA) has started taking actions on its plan to tackle drug competition within the field of prescription drugs and facilitation of lower-cost alternatives.
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Two steps have been highlighted in a release revealing the initiation of its Drug Competition Action Plan. These include the publication of a list of off-patent, off-exclusivity branded drugs without approved generics and implementation of a new policy to expedite the review of generic drug applications where competition is limited.
“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, Dr Scott Gotlieb. “Getting safe and effective generic products to market in an effective 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 list of off-patent, off-exclusivity branded drugs, posted by the FDA, will be continuously refined and updated to encourage generic development and ensure transparency around drug categories where more competition will be beneficial to patients.
Additionally, the agency is implementing a change in its policy on the prioritisation of its review of generic drug applications, where it will speed up the process until there are three generics approved for a given drug product. This change is hoped to reduce prices for consumers through increasing market competition with multiple approved options available.
This announcement follows from Gottlieb’s promise earlier this year to tackle drug prices and competition. “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,” Gottlieb added.