October 24, 2025
TOPLINE
On Monday, the nonpartisan Congressional Budget Office (CBO) released a revised estimate on the impact of the Optimizing Research Progress Hope And New (ORPHAN) Cures Act, a Big Pharma-backed policy that will help drug manufacturers keep prices high on blockbuster brand name drugs at the expense of seniors and taxpayers. CBO’s updated analysis estimates that the ORPHAN Cures Act will cost $8.8 billion between 2025 and 2034, up from its original estimate of $4.9 billion.
“The updated analysis from CBO confirms the ORPHAN Cures Act will saddle seniors and taxpayers with billions more in higher prescription drug spending by exempting blockbuster brand name drugs and helping Big Pharma keep prices high on their biggest money makers,” said CSRxP executive director Lauren Aronson in a statement. “Subsequent analysis has shown the policy will impact blockbuster brand name drugs and help Big Pharma keep prices high on a whole category of products, amounting to a massive bailout at the expense of seniors and taxpayers.
“Now that Congress is armed with more accurate information, lawmakers must remedy the situation by repealing Big Pharma’s blockbuster bailout,” Aronson continued.
Read more on the ORPHAN Cures Act HERE.
Also, in case you missed it, Big Pharma giant Merck recently surpassed a major milestone in the brand name drug maker’s latest scheme to further delay competition and maintain monopoly pricing on blockbuster cancer drug Keytruda, securing approval from the U.S. Food and Drug Administration (FDA) for a new, subcutaneous version of the drug. As coverage from The New York Times notes, as patent exclusivity on the current version of Keytruda approaches the end of its life, already significantly extended by patent abuse, Merck is following “a well-worn playbook…by develop[ing] a new version of the drug, given as a shot under the skin,” that will “keep Keytruda revenue flowing.”
Read more on Merck’s product hopping playbook on Keytruda HERE.
QUOTE OF THE WEEK
“Where there’s alignment with my Republican colleagues is on the marketplace and competition. It’s being stifled. If you can make money by continuing to keep other competitors out…then we don’t get innovation. That’s the irony. You have a business model facilitated by abuse of the patent system.”
U.S. Senator Peter Welch (D-VT)
DATA POINT YOU SHOULD KNOW
Four in Five or 80 Percent
The number of Americans who support changes to patent laws to address drug pricing, according to a recent survey from the Initiatives for Medicines, Access, and Knowledge (I-MAK).
TWEETS OF THE WEEK
@STAT News: “The Congressional Budget Office says exemptions for orphan drugs as part of Medicare price negotiations will cost taxpayers an additional $3.9 billion.”
@P4AD_: “The CBO just re-scored the pharma-backed ORPHAN Cures Act — and it’s even worse than we thought. Now estimated to cost taxpayers $8.8 billion (originally $5B), the bill would exempt blockbuster drugs like Keytruda, Brukinsa, and Jakafi from Medicare negotiation — sending billions in savings away from patients and into Big Pharma’s pockets.”
ROAD TO RECOVERY
Inside Health Policy: CSRxP: Congress Must Repeal Orphan Cures Act
Earlier this year, Congress passed a Big Pharma-supported policy as a rider in a larger legislative package without having the right information on the brand name prescription drugs that would be impacted — or the true cost to American seniors and taxpayers. Subsequent analysis has confirmed the policy would help Big Pharma keep prices high on some of their biggest blockbuster money makers, amounting to a massive bailout for brand name drug companies at the expense of billions of dollars in previously underestimated costs for the American people. Congress did not have that information at the time the rider was passed into law. As the true impact of this pharma-backed policy comes to light, lawmakers must remedy the situation by repealing the Big Pharma bailout on blockbuster brand name drugs.
Inside Health Policy: Shaheen, Collins Revive Bill To Limit Citizen Petitions Blocking Generics
Two senators who are key figures in the current fight over government funding have reintroduced legislation that would aim to expedite market entry of generic drugs and lower drug prices by cracking down on brand drug manufacturers’ use of FDA citizen petitions to delay generic drug approvals. The Ensuring Timely Access To Generics Act is sponsored by Senate Appropriations Chair Susan Collins (R-ME) and Sen. Jeanne Shaheen (R-NH), both GOP leaders in the ongoing negotiations over the government shutdown and extension of the enhanced Affordable Care Act premium tax credits. The bill’s reintroduction raises the possibility it could end up as part of a bipartisan health care compromise.
PHARMA’S POOR PROGNOSIS
Endpoints News: Drug Launch Prices Spiked From 2022 To 2024, New ICER Report Finds
The nonprofit drug pricing watchdog’s report looked at launch prices for every new drug and biologic approved between 2022 and 2024. It found a 24% increase (from $249,257 to $308,749) in the inflation-adjusted median annual list price of newly-launched drugs… Gene and cell therapies, orphan drugs, first-in-class drugs, and oncology and endocrine/metabolic drugs “were all associated with higher launch prices,” the report says.
Inside Health Policy: CBO Adds $3.9B To Estimate Of IRA Orphan Drug Exemption Cost
Exempting all orphan drugs from selection for the Medicare drug price negotiation program would cost taxpayers $8.8 billion by 2034, according to the Congressional Budget Office’s updated score, an increase of $3.9 billion from its original estimate after CBO accounted for the impact of newly exempting certain expensive blockbuster drugs sold under Part B… Groups like Patients for Affordable Drugs (P4AD) and the Campaign for Sustainable Rx Pricing expected to see the cost of implementing the ORPHAN Cures Act provision of the OBBBA rise significantly upon release of the CBO rescore. With the additional information from CBO, the groups are pressing lawmakers to repeal the law before the policy update takes effect.
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