Healthcare Supply Chain Association President and CEO Todd Ebert has praised the U.S. Food and Drug Administration's decision to prioritize abbreviated new drug applications for generic drugs with only one manufacturer, sometimes known as "sole source" products.
Published reports say the change, announced by the FDA last week, could effectively speed up the review of such drugs, with the goal of increasing competition, helping with drug shortages and potentially driving down the cost of expensive generics that have no competition.
The change came in the form of an updated Manual of Policies and Procedures on the prioritization of ANDAs by the FDA's Office of Generic Drugs.
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"The Healthcare Supply Chain Association and our member GPOs have a unique line of insight into the causes of generic price spikes, and we are committed to reducing costs and increasing competition and innovation in the market," Ebert said in a statement. "We have worked with Congress, FDA, and industry stakeholders to adopt practical solutions, including review prioritization, to help address generic price spikes."
While noting that competition in the generic drug market may increase, Ebert said that there is more to be done "to ensure generic medications are accessible and affordable to healthcare providers and patients who rely on them. We encourage Congress and FDA to prioritize review of generic drugs with two or fewer manufacturers, or where a price spike has already occurred, particularly in the generic injectable market."
Earlier this month, a bill was introduced in the Senate that would create a priority review voucher program. It essentially would reward companies for developing a generic with just one competing product on the market, or one that's on the FDA's drug shortage list.
The FDA said last week that submissions that do not receive expedited review will be examined in the order in which they are received.
Twitter: @JELagasse