Welcome to the Week in Review.
Court Watch: US v Pharma
Another judge has cast doubt on pharma’s arguments challenging Medicare negotiation. On Thursday, Boehringer Ingelheim’s high-priced lawyers presented the corporation’s case against the program in a Connecticut court, where U.S. District Judge Michael P. Shea expressed skepticism of their claims. The lawsuit is one of nine filed by the drug industry and its allies to block the wildly popular program in the Inflation Reduction Act. Boehringer’s suit aims to preserve its pricing power over blockbuster drug Jardiance, one of the first 10 drugs up for negotiation – which generated $8 billion in sales in 2023. A lower negotiated price for Jardiance would be transformational for patients like Gillian from Virginia, who is living with type 2 diabetes and was prescribed the medication to control her blood sugar, but has to forgo it because of the $680 monthly price tag. The corporation’s lawsuit is a “grab bag” of many constitutional and procedural arguments raised in several of the industry’s earlier cases. So far, these claims have failed to persuade judges, with four rulings already favoring patients over the pharmaceutical industry. As evidenced by these recent victories for patients and consumers in court, we are making progress in the battle against pharma’s monopoly power, but the fight is far from over. — (Bloomberg Law, Law360, FightPharma.org, P4ADNOW, Boehringer Ingelheim, P4AD, STAT News, BioSpace, CNBC)
Today In Big Pharma Fear-Mongering
The Inflation Reduction Act ensures robust support for orphan drug development despite the pharmaceutical industry’s claims. As David Mitchell, founder of Patients For Affordable Drugs, pointed out, “Drug companies can still make lots of money on additional indications for orphan drugs by expanding the number of patients who are treated. They don’t need unending, serial orphan drug exclusivity to make new indications profitable.” Orphan drugs with multiple indications are highly unlikely to meet the spending threshold for Medicare negotiation, thus maintaining incentives for research and development. The Inflation Reduction Act preserves critical support such as tax credits for clinical trials and priority review vouchers, ensuring continued innovation in the rare disease space. Furthermore, increased investment in small molecule drugs following the Inflation Reduction Act’s enactment contradicts industry fears and demonstrates the law’s balanced approach to lowering drug prices while fostering innovation. — (Bloomberg Law, Brookings Institute)
CBO Boost: Patent Reform Bills’ Savings Skyrocket
Those working to rein in Big Pharma’s abuse of the drug patent system received welcome news last week as the Congressional Budget Office (CBO) rescored a key bipartisan bill aimed at curbing patent thickets and product hopping. The Affordable Prescriptions for Patients Act (S. 150) now projects $3 billion in savings over a decade — nearly tripling its previous estimate of $1.1 billion. This latest update builds on the March rescoring of two other competition bills, all of which have passed through committee with bipartisan support:
- Preserve Access to Affordable Generics and Biosimilars Act (S. 142): Savings increased from $685M to $1.65B
- Stop STALLING Act (S. 148): Projected savings rose from $117M to $401M
Collectively, these three bills now project roughly $5 billion in savings over ten years. In addition to accelerating generic drug entry and fostering competition to lower drug prices for millions of Americans, these enhanced savings offer a timely solution to fund other crucial health care priorities in an end-of-year funding package. — (Axios, Politico, Inside Health Policy, CBO, P4ADNOW, CBO, CBO)
ICYMI
The majority of Americans over the age of 65 (54 percent) are reportingly very concerned about the cost of prescription drugs. Thankfully, several drug price reforms in the Inflation Reduction Act are already driving savings for patients on Medicare. As additional reforms go into effect in 2025, including the $2,000 out-of-pocket cap and lower negotiated drug prices on ten widely-used drugs, millions of patients on Medicare will see further savings. But more is needed to lower drug prices across the board.