What's New in the FDA’s Drug Pricing Strategy?


Experts at Waxman Strategies have been closely tracking recent actions by the U.S. Food and Drug Administration (FDA), Congress, and industry to lower the cost of prescription drugs through greater competition and transparency in pharmaceutical markets. They’ve also been identifying potential solutions to an issue likely to gain steam as the 2020 presidential election approaches.

In a new post for To the Point, former congressman Henry Waxman, Bill Corr, Kristi Martin, Jeremy Sharp, and Sophia Duong present a detailed timeline of the FDA’s strategy to lower drug prices, focusing on five key areas: sole-source drugs, generics, biosimilars (generic alternatives to biologic drugs), anticompetitive behaviors, and drug importation. The timeline will be updated throughout the year.

The post also highlights steps taken by the Trump administration to promote competition in the important biologics market, which includes top-selling medications like Humira and Rituxin. According to the authors, the FDA’s Biosimilar Action Plan “has the potential to do more to foster competitive drug markets than all other steps announced or taken to date.” But there is more to do, they say, to address imbalances in reimbursement and coverage for biosimilars, particularly in the Medicare program.

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