+ Regulatory
Caitlin Nordahl | Jul 8, 2017

FDA hoping to increase availability of generic drugs

The U.S. Food and Drug Administration said it is taking steps to promote wider access to lower-cost alternatives to prescription medication and facilitating efforts to bring more generic medications to the market.

“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,” FDA Commissioner Scott Gottlieb said in an FDA 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.”

The agency said it has developed a list of drugs that are currently off-patent and off-exclusivity but that do not yet have approved generics in an attempt to spur development of lower-cost alternatives. Further, the FDA said it also implemented a new policy that will make it quicker to review generic drugs for which there is little 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 said in the release.

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