Orphan Drug Act & Modern Drug Pricing
TL/DR –
February is recognized as Rare Disease Month, during which health policy strategist Kristi Martin discussed the impact of the Orphan Drug Act on rare disease treatment in an episode of “Managed Care Cast.” Martin described how the Orphan Drug Act, passed in 1983, transformed rare disease treatment by aligning scientific advances, government investment, and market incentives. She also discussed the current policy landscape and the potential need for reform, highlighting cost and equity challenges as well as the importance of federal agencies such as the NIH, FDA, and CMS in sustaining innovation.
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The Impact of the Orphan Drug Act on Rare Disease Treatment: A Podcast Recap
February, with its unique 28-day span, has been designated as Rare Disease Month. In this context, Maggie Shaw, chief editor at The American Journal of Managed Care®, hosts a new episode of Managed Care Cast, where important topics related to rare diseases are discussed.
Understanding The Orphan Drug Act
In the recent podcast, the guest was Kristi Martin, a seasoned policy strategist based in Washington, DC. Martin, who has an extensive background in implementing significant legislation such as the Affordable Care Act and the Inflation Reduction Act, discussed the Orphan Drug Act. This act, which was passed in 1983, was a bipartisan, patient-driven initiative that revolutionized the treatment of rare diseases by aligning scientific breakthroughs, government funding, and market incentives.
Need for Reform In Today’s Policy Landscape
Martin explains how the policy environment of today has significantly changed, giving rise to new cost and equity challenges. These are particularly evident as the Orphan Drug Act intersects with current drug pricing policy, including the exemption of orphan oncology drugs with high spending from negotiation. Despite acknowledging the life-saving impact of the law, Martin suggests that a reform may be necessary, including rethinking incentives for blockbuster drugs, refining orphan drug eligibility, and moving toward more precise, evidence-based negotiation. At the same time, she emphasizes the federal government’s ongoing role in fostering innovation through agencies such as the NIH, FDA, and CMS.
This episode can be streamed above or via the following podcast services:
iTunes
TuneIn
Stitcher
Spotify
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