University of Florida Study Finds Generic Drug Prices Rise as Competition Goes Down
Washington, D.C. – Ahead of an important vote in the House of Representatives to reform the Food and Drug Administration, a recent University of Florida study found that the rise in cost of generic prescription drugs may be due to a lack of market competition. U.S. Rep. Gus Bilirakis (FL-12) has a bipartisan provision in the FDA Reauthorization Act (H.R. 2430) to spur the development of new generic drugs and help combat high drug prices.
According to the study, one underlying factor to the lack of competition is the lengthy timeline for approval at the FDA. It can take years to complete a review, and even after that, only nine percent of first-time applications are approved. This lengthy, often unsuccessful process can deter generic drugmakers from developing medicines that patients need.
Bilirakis’ provision directly addresses this problem by:
• Requiring the FDA to prioritize the approval of generics within eight months when there are three or less approved drugs on the market,
• Creating the Competitive Generic Therapies program to have the FDA work with drugmakers to improve the quality of submissions, so more applications can be approved the first time around,
• Giving the FDA the tools to maintain an accurate list of the drugs that have little or no other competition, and
• Providing an incentive for drugmakers to enter markets where only one or no generic drug exists.
“Patients should not have to worry about the price of the medicines they rely on skyrocketing overnight. Too often, we have seen bad actors take advantage of monopolies in the market and astronomically raise the price of lifesaving drugs. By incentivizing lower-cost generic drugs to enter markets where there is a monopoly, we are using free market solutions to increase competition and drive costs down,” said Bilirakis.
The FDA Reauthorization Act, Bilirakis’ provision is Title VIII of the bill, is expected to be considered on the House floor on Wednesday.