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FDA Seeks to Boost Generic Drugs

Agency announces measures to increase access to more lower-cost options

FDA Generic Drugs

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There will be a faster federal review process for generic drugs, which should help lower prices.

The U.S. Food and Drug Administration (FDA) is taking the first steps in its previously announced effort to lower medication prices for consumers by increasing the availability of cheaper generic versions of drugs.

The agency said it will speed the review process for generic drugs until there are at least three competing medications on the market — the point at which prices tend to decline significantly. The FDA is also publishing a list of drugs with expired patents but no generic competition, in order to encourage manufacturers to take advantage of the opportunity. The FDA also will expedite applications to make generic versions of those drugs.



“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 a press 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.”

In addition, the agency announced a meeting for July 18 in which it will seek input on how to streamline the regulatory process to get more generic drugs into the pipeline. 

But it may take more than such market-based incentives to get drug companies to lower prices. The MarketWatch website reported that in June, drug companies increased the prices of 14 common generic medications by 20 to 85 percent.



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