FOIA’d MFN Agreements Reveal New Details — But Key Terms Remain Secret
Newly released, heavily redacted Pfizer and Eli Lilly MFN agreements reveal concerning drug exclusions and terms while leaving key details about pricing and implementation unknown. That’s according to Public Citizen, which obtained the heavily redacted agreements through FOIA litigation. Eli Lilly’s deal, for example, excludes Mounjaro and Zepbound from certain MFN pricing requirements — undercutting one of the administration’s biggest selling points for the deals. According to Public Citizen, the exclusion could reduce potential first-year GENEROUS savings by up to $300 million. The documents also confirm that Pfizer’s agreement takes precedence over GENEROUS where the two agreements conflict, raising additional questions about the program’s potential long-term savings. Ultimately, these disclosures reinforce a central concern with these voluntary agreements: we still don’t know which drugs are covered, what prices manufacturers have agreed to, or how much savings they will actually deliver for patients and taxpayers. — [Public Citizen, Washington Post, PharmaPhorum, NBC Polling, STAT News]
Pharma Says the Quiet Part Out Loud on Innovation
At a specialty pharmacy conference this week, BRG executives spoke candidly about the financial calculations behind investment in new treatments, asking “why would you want to invest in this space to get your 10 to 20 adopted cell and gene therapies a year if you could invest in AI or a data center, where you have a more certain return?” It reveals what the pharmaceutical industry intends to protect when it warns that policies to lower drug prices could threaten innovation. In parallel, AbbVie EVP Perry Siatis claimed this week that Germany’s pricing and reimbursement policies “veer drastically” from incentivizing innovation. It’s rich that AbbVie is lecturing Germany on “fair contribution” while their blockbuster drug Humira is a textbook patent-thicketing case, preventing biosimilars from reaching the market in the U.S. for years longer than they did in Germany. Increasing competition is one of the primary ways to incentivize true innovation. — [Endpoints News, AJMC]
Upcoming CBP Drug Importation Change Could Harm Patients
A new Customs and Border Protection rule change taking effect October 22nd will require prescription drugs mailed from abroad to go through a formal customs entry process. In practice, this change will likely make the personal importation of lower-cost medicines from other countries very difficult and potentially impossible. An estimated 2.3 million Americans have purchased prescription drugs outside the U.S., and members of P4AD’s patient community could be directly affected. Maureen has purchased her brand-name seizure medications from Canada for years, while Darlene’s blood pressure drug costs five times more in the U.S. than in Canada. Even P4AD’s founder David Mitchell relied on Canadian pharmacies to purchase Eliquis when his Part D plan wouldn’t cover the drug — or allow him to pay out-of-pocket for it. At the time, he was able to purchase it for just a third of the US price. Patients shouldn’t have to look outside the U.S. to afford the medicines they need, but for those who already do, disrupting this pathway without addressing the high prices that drove them there could put their access to treatment at risk. — [Wall Street Journal]
ICYMI: Public Interest Patent Law Institute (PPLI) sent a letter to the House Judiciary Subcommittee this week highlighting how drugmakers use terminal disclaimers to accumulate multiple closely related patents on the same invention, creating costly legal hurdles for generic competitors. As PPLI put it, “a company holding dozens of them can turn one dispute into a war of attrition.” The bipartisan ETHIC Act would limit drugmakers to asserting one patent from a terminally disclaimed group against a generic or biosimilar competitor, reducing a barrier to lower-cost competition. — [PPLI]