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28 June 2017Americas

FDA to increase drug competition and speed up ANDA reviews

The US Food and Drug Administration (FDA) has revealed plans to increase competition in the US market for prescription drugs, as well as to facilitate the entry of generic drugs into the market.

As part of an  announcement posted yesterday, the FDA published a list of off-patent, branded drugs without approved generics.

The FDA also implemented a new policy to expedite the review of generic drug applications—it will expedite review until there are three approved generics for a given drug.

Scott Gottlieb, FDA commissioner, 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.”

He added: “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 will continue to refine and update the off-patent list periodically to ensure continued transparency, it said.

It added: “The agency will unveil additional aspects of this plan in the near future and will continue to communicate with the public as additional elements of this plan are implemented.”

As previously  reported by LSIPR, the FDA announced its intention to target the barriers to generic drug competition last week.

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Americas
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