What was once a $5 billion Big Pharma giveaway has exploded to $8.8 billion – a windfall for drug corporations at the expense of patients and taxpayers.
WASHINGTON, D.C. — The Congressional Budget Office (CBO) has re-scored the pharmaceutical carveout known as the ORPHAN Cures Act, and the results confirm what patients feared: it’s even more expensive – and more harmful – than originally thought.
The new score reveals the bill will cost taxpayers $8.8 billion, up from a massive $5 billion initially. The CBO’s earlier analysis failed to fully account for the impact of exempting blockbuster drugs like Keytruda, Brukinsa, and Jakafi from Medicare price negotiations – a change that funnels billions in savings away from patients and straight into Big Pharma’s pockets.
“The ORPHAN Cures Act is a wildly expensive handout to Big Pharma that will harm patients, drain taxpayer dollars, and weaken the government’s ability to rein in high drug prices,” said Merith Basey, executive director of Patients For Affordable Drugs Now. “And yet, the insatiable pharmaceutical industry continues to demand more – spending record sums this year to advance additional carveouts like the EPIC Act, which would exempt even more blockbuster drugs from negotiation. Any support for these bills goes against the will of the 90% of Americans who want Congress to go further to lower drug prices – not facilitate another handout to Big Pharma.”
The ORPHAN Cures Act exempts drugs approved for two or more rare diseases from Medicare negotiation, including blockbuster medicines that already generate billions. If drugs have both orphan and non-orphan designations, ORPHAN resets their negotiation timeline to the date of their newest approval, even if they’ve been on the market for years. Rare disease research incentives have existed in the U.S. under the Orphan Drug Act for more than 40 years, and investment in drug R&D has hit record levels since the Inflation Reduction Act was passed, directly contradicting the industry’s fearmongering about innovation.
Following the ORPHAN Cures Act, two additional industry-backed bills – the EPIC Act and MINI Act – threaten to further weaken Medicare’s negotiating power and inflate drug costs:
- The Ensuring Pathways to Innovative Cures (EPIC) Act (H.R. 1492): Would unnecessarily delay small-molecule drug eligibility for negotiation from 9 to 13 years — keeping prices high for four extra years and costing taxpayers an estimated $10 billion.
- The Maintaining Investments in New Innovation (MINI) Act (H.R. 1672): Would extend exclusivity for genetically targeted drugs from 9 to 13 years, using the same flawed innovation argument.
Both rely on debunked claims that negotiation stifles innovation – and both would sabotage President Trump’s ability to secure a better deal for Americans.
Across the country, patients are mobilizing against these industry giveaways. Collectively, P4ADNow’s community has sent 53,886 letters urging lawmakers to reject carveouts like ORPHAN, EPIC, and MINI and protect Medicare’s power to negotiate lower prices.
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Patients For Affordable Drugs Now is the only national, patient advocacy organization focused exclusively on policies to lower drug prices. We empower and mobilize patients and allies, hold accountable those in power, and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4ADNow is bipartisan and does not accept funding from organizations that profit from the development or distribution of prescription drugs. To learn more, visit: PatientsForAffordableDrugsNOW.org