The Food and Drug Administration (FDA) has announced they are taking two important steps that will make generic medicine more affordable and increase competition in the prescription drug marketplace.
The agency published a list of brand name medications that are off patent and off exclusivity that don’t currently have approved generics. The list was published in hopes that drug manufacturers will jump on creating new lookalikes for the brand name drugs listed. The FDA has yet to approve any applications for generic drugs related to the list they released.
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The list is to be updated and refined periodically, in order to ensure continued transparency around drug categories.
These actions are a result of the agency’s new Drug Competition Action Plan, which was 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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
80% of drugs filled in the United States are for generic medicine.
Nearly 8 out of 10 drugs filled in the United States are for generic medicines, but the majority of high costs are related to brand name drugs.
Generic drugs are required to meet rigorous standards established by the FDA. These criteria include identity, strength, quality, purity, and potency. The FDA limits how much variability in purity, size, strength, and other parameters are allowed, in mass-production.
Consumers see significant price reductions when there are multiple FDA-approved generic medicines available.
It was also announced that the FDA will take a new approach to prioritizing its review of applications for generic medicine. The review of applications for generic drugs will be expedited, until there are three approved generics for a given drug. Significant price reductions are visible when there are multiple generic medicines available.
The FDA says these steps are part of a series that will hopefully help tackle the important issue of high-cost prescription drugs.
“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,” said Gottlieb.