Federal Budget Reconciliation Bill (aka the “One Big Beautiful Bill Act of 2025”) is law; What’s next for Congress?
It seems like months ago, but Congress gave President Trump his wish of signing into law his legislative priorities on July 4th. It took the help of Vice President J.D. Vance, but the Senate passed the bill 51-50 on July 1 and the House followed suit on July 3 by a vote of 218-214. Democrats immediately seized the opportunity to make the legislation’s Medicaid provisions a major issue in the 2026 mid-term elections, while Republicans scurried to compile talking points to counter the Democrats’ attacks. The Senate made changes to the original House version, and for those looking for a “one stop shop” of health policy provisions in the OBBA, the Kaiser Family Foundation has compiled a comprehensive directory of the law’s health provisions. The rhetoric on both sides regarding the impact on those currently receiving health care coverage through Medicaid hasn’t exactly been 100% factual, with Democrats categorizing the reforms as catastrophic cuts that will decimate the program and Republicans saying provisions will simply cut waste and fraud. The real-world impact is likely somewhere in the middle (which is often the case). Congress quickly moved on from the reconciliation debate to begin addressing the President’s Budget Request for Fiscal Year 2026 and other priorities. Advocates remain hopeful that Congress will consider a variety of bipartisan health care issues that weren’t addressed in the reconciliation bill, including the Give Kids a Chance Act (which includes reauthorization of the now expired rare pediatric disease Priority Review Voucher (PRV) program) and the Accelerating Kids’ Access to Care Act (which eliminates barrier to children receiving care from out-of-state health care providers). Action on both issues, and a possible large end-of-year health care package, is expected when Congress returns from its recess on September 2. The House Energy & Commerce Committee is planning hearings each week during September, so it will be a pivotal month for critical issues to advance for consideration before the end of the year.
Trump Administration zeroes in on “Most Favored Nation” drug pricing program as the President gives 17 biopharma CEOs a new 60-day deadline
President Trump renewed his call for biopharma companies to “end international freeloading” and take immediate action to eliminate international price differentials in a July 31 letter sent to 17 biopharma company CEOs. The President announced that he had sent the letters on his Truth Social platform. The White House followed up with a Fact Sheet touting the letters. While the May MFN executive order demanded that companies immediately change drug prices across the board, the recent letter appears to indicate Trump has modified his expectations. Specifically, Trump said he expects “binding commitments” from all companies to offer MFN pricing to all Medicaid recipients (who already pay little or nothing for most medications) and wants manufacturers to stipulate that they will not offer other developed nations better prices for new drugs than prices offered in the United States (which includes prices in Medicare and the commercial market). Trump also said the Administration plans to leverage U.S. trade policy to support manufacturers in raising prices internationally provided that increased revenues abroad are reinvested directly into lowering prices for American patients and taxpayers. The letters inform manufacturers that if they “refuse to step up,” the federal government “will deploy every tool in our arsenal to protect American families from continued abusive drug pricing practices.” Letters were sent to AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. While the continued harsh rhetoric from the Administration is not helpful to the long-suffering biotech/biopharma market, it remains to be seen how the Administration will follow through on the rhetoric. We may know more on October 1…or we may not!
FDA provides additional details on Commissioner’s National Priority Review Voucher (CNPV)
The FDA released additional information in July surrounding the recently launched CNPV program, which offers companies a faster review timeline (potentially reducing the standard 10-12 month review period to 1-2 months after submission of the final application, including “enhanced communication” with FDA reviewers). The CNPV pilot is designed to accelerate the FDA’s review of drugs that align with national health priorities, such as addressing a health crisis, delivering innovative cures or increasing domestic drug manufacturing. One new addition to the July guidance included a focus on “increasing affordability” of treatments. This priority was not included in the original list of priorities. The FDA said examples of meeting this affordability priority may include “…a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or a product that reduces other downstream medical utilization to lower overall healthcare costs.” No additional details have been provided on this priority, creating questions and some angst from stakeholders. The FDA developed a central hub on the FDA website for prospective applicant companies to learn more about the program and submit applications. The agency expects to issue no more than 5 vouchers in its first year of operation. The FDA’s Q&A site states that vouchers are non-transferable but will remain valid through changes in a company’s ownership. The vouchers expire in two years and both drugs and biologics are included. Companies are allowed only one submission. Applications are currently being accepted. Industry officials expressed cautious optimism about the pilot program, especially U.S.-based innovators. Ex-U.S. stakeholders have expressed concerns about potential exclusion from the pilot program.
Maryland declares two drugs “unaffordable”; proceeds to potentially set upper payment limits
Maryland’s Prescription Drug Affordability Board (PDAB) unanimously voted to consider price limits for popular diabetes drugs Jaridance® and Farxiga® after its review found the two medications aren’t affordable for patients in the state. The board’s decision opens the door for upper payment limits (UPLs) on both products. It’s the first action by Maryland’s board since the legislature passed a bill earlier in 2025 that expanded the PDAB’s authority. Maryland is the second state to initiate potential price limits on certain drugs. Colorado’s PDAB labeled Amgen’s Enbrel® unaffordable, but Amgen filed suit to stop a price limit from being imposed, citing the Colorado PDAB’s “sweeping authority” to “impose arbitrary price controls”. The Colorado case is Amgen v. Mizner. Some health care consumer groups heralded the Maryland PDAB’s decision to move forward with potential price limits, while rare disease organizations such as the Rare Access Action Project said, “This action by the PDAB does nothing to relieve out-of-pocket costs for patients in the state, and will lead to unintended consequences for patient access in Maryland to these two products.”
Health Policy Snippets
- More instability at FDA. Vinay Prasad, a top official at the Food and Drug Administration, suddenly departed after a series of controversial decisions about a treatment for boys with Duchenne muscular dystrophy. Prasad was the head of the FDA division that regulates vaccines, gene therapies, and blood products and had only been in the position three months. He was also the agency’s chief medical and scientific officer, making him a top adviser to Commissioner Makary. Prasad had come under scrutiny from multiple stakeholders in recent weeks, including the editorial board of The Wall Street Journal. Observers have speculated that Prasad’s departure came after some in the Trump Administration, who favor a “right to try” approach to experimental therapies for rare and hard to treat diseases, felt Prasad’s perspectives were undermining the ability of patients suffering from incurable diseases to receive such therapies.
- Congress likely to revisit China biotech policies. The BIOSECURE Act—which would have stopped U.S. companies from doing business with some Chinese companies with alleged ties to the communist government in China—passed the House last year with bipartisan support but has yet to be re-introduced in 2025. It’s likely that Congress will revisit this issue and others dealing with China as a threat to U.S. national security via its expanding biotech infrastructure soon. Interest in the issues is partially driven by an April 2025 National Security Commission on Emerging Biotechnology report. The Commission reported that the United States’ growing dependence on China for numerous critical supply chain elements is a national security vulnerability. The report said “…biotechnology can be the key to increasing supply chain security, resilience, and scalability, by allowing the U.S. to control its own access to critical components.” With the federal budget reconciliation bill passed, expect Congress to again focus on these issues, with potential movement in 2026.
