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FDARA is Boosting Generic Drug Competition


WASHINGTON, DC – Almost exactly one year ago, President Trump signed into law H.R. 2430, the FDA Reauthorization Act (FDARA). This important, bipartisan legislation reauthorized the Food and Drug Administration’s (FDA’s) critical medical product user fee programs, ensuring the agency has the tools it needs to more efficiently deliver safe and effective drugs, devices, and treatments to patients.

Included in H.R. 2430 was H.R. 749, the Lower Costs Through Competition Act, authored by committee members Reps. Gus Bilirakis (R-FL) and Kurt Schrader (D-OR). The provision created an expedited approval process for a generic drug for products that do not have competition. This important step forward will help safely, and expeditiously move life-saving drugs to the market and reduce cost for consumers.

Yesterday, the FDA announced that they approved the first generic drug under this authority, thus boosting marketing competition.

“Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition,” said FDA Commissioner Scott Gottlieb, M.D. in the agency’s announcement. “The quick implementation of this new pathway is part of our broader effort to foster generic competition and help address the high cost of drugs. So are our efforts to narrow the time it takes for generic drugs to reach the market by reducing the number of review cycles that generic applications typically undergo. This new generic drug application was also approved in its first cycle of review. This approval demonstrates that the competitive generic therapy pathway is efficient and open for business. This pathway is a key step in making safe and effective generic drugs available to patients quickly and ensuring there’s adequate competition so patients have affordable access to the treatments they need.”

It’s just the latest step to ensure patients have access to more, affordable generic drugs. At the beginning of the year, The Washington Post reported that generic drugs had a banner year in 2017 with the approval backlog dramatically lower than years past.

To learn more about FDARA, click HERE.


Health (115th Congress)