BIO marks wins on PPRV, PBMs

BIO celebrates passage of PPRV reauthorization and PBM reforms

BIO celebrated inclusion of two of its legislative priorities in the spending package passed on Feb. 3: reauthorization of the Pediatric Priority Review Voucher (PPRV) and pharmacy benefit manager (PBM) reform.

The PPRV program was reauthorized until 2029.

BIO’s view: “The PPRV program provides critical incentives for rare disease research, and its reauthorization provides stability and confidence for biotech innovators who are leading the way in the discovery of breakthrough treatments,” said a statement from BIO President & CEO John F. Crowley hailing the “bipartisan victory for children and families living with rare diseases.”

The first major federal PBM reforms in decades prevent PBM compensation from being linked to the list price of a drug and add measures to increase PBM transparency.

BIO’s view: “This funding package also takes important first steps to rein in Pharmacy Benefit Managers (PBMs),” Crowley said. “For too long, these middlemen have driven up costs for patients.”

Read more on Bio.News.

PASTEUR Act to tackle AMR is reintroduced

Bipartisan legislation to address the deadly threat of antimicrobial resistance (AMR) was reintroduced in the House on Feb. 4.

The Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act encourages antimicrobial development through “a subscription-style model which would offer antibiotic developers predictable payments in exchange for access to their antibiotics, encouraging innovation” to fight AMR, says a press release from Rep. Earl “Buddy” Carter (R-GA).

Why it matters: Antibiotic resistance is expected to contribute to nearly 170 million deaths worldwide between 2025 and 2050, according to a Lancet analysis. A recent WHO report found about 1 in every 6 bacterial infections in 2023 were drug-resistant.

Market challenge: “A new antibiotic routinely costs at least $1 billion to develop, but struggles to reach $100 million in annual sales once on the market,” explains a Working to Fight AMR fact sheet. “The startups developing them often can’t stay afloat.”

Updates: The reintroduced bill adds new provisions for more rigorous vetting of drugs to be supported and expanded outpatient stewardship of AMR. It’s sponsored by Reps. Carter, Scott Peters (D-CA), Nick Langworthy (R-NY), Mike Levin (D-CA), and Mike Carey (R-OH).

BIO’s view: "This updated PASTEUR legislation would help to repair the broken marketplace for antimicrobials by enabling a business model centered around the appropriate use of new and novel treatments to address the most threatening infections. We commend these bipartisan leaders in Congress for introducing this critical legislation,” says a statement from BIO President & CEO John F. Crowley.

NIH Director says no studies link vaccines and autism, outlines modernization

National Institutes of Health (NIH) Director Jay Bhattacharya acknowledged no studies indicate a link between any vaccine and autism and discussed plans to modernize NIH in a Senate hearing.

The hearing by the Senate Health, Education, Labor & Pensions (HELP) Committee on “Modernizing the National Institutes of Health: Faster Discoveries, More Cures” was held Feb. 3.

“I have not seen a study that suggests any single vaccine causes autism,” Bhattacharya acknowledged under questioning.

Why it matters: Several “vaccine cynics” were appointed the week before to the Interagency Autism Coordinating Committee, but the theory linking vaccines to autism “has been debunked,” Sen. Maggie Hassan (D-NH) told Bhattacharya. “Relitigating debunked theories about vaccines doesn’t get us closer to the answer of what causes autism.”

NIH modernization: Bhattacharya told of plans for more efficiency, including by centralizing peer review for grants and prioritizing research impacting Americans’ health. Congress approved an increased NIH 2026 budget that same day.

Read more on Bio.News.

What Else to Read

BIO President & CEO John F. Crowley to testify at Feb. 11 House Energy & Commerce Health Subcommittee hearing: The hearing on “Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain” will include “representatives across the entire prescription drug supply chain—pharmaceutical manufacturers, distributors, and providers—to examine the root drivers of prescription drug costs and ways to keep them both accessible and affordable,” according to an announcement from the committee and subcommittee chairs. Watch the hearing here.

TrumpRx website launched. The website provides links to offers of some discounted prescription drugs being sold direct from drug makers, though these purchases cannot be made with insurance. The website, which has been promoted as part of the Trump Administration’s Most Favored Nation (MFN) price-control effort, also touts the idea of MFN. BIO explains why MFN won’t work and outlines a better way to “Simplify the System” to reduce the cost of drug prices. Read more here.

KFF poll:Aside from cost, prior authorization is the biggest burden to getting health care. “Beyond costs, insured people report a whole host of issues navigating the health care system,” said a KFF report on their poll results. The “biggest burden” not related to costs is prior authorization—the practice of insurers requiring authorization before a patient can have a doctor-prescribed treatment or test, KFF said. BIO opposes prior authorization as a utilization management tactic that decreases patient access. Read more here.

Insurance companies have become “the most destabilizing force many patients face,” in getting medical care, writes Kathy Oubre, CEO of Louisiana’s Pontchartrain Cancer Center, in RealClearHealth. “We’ve seen cancer care advance dramatically, while watching access to that care become more difficult,” she writes. “Insurers and their pharmacy benefit managers (PBMs) have built a system that works against the very people it is supposed to serve by putting profits over patients. Prior authorizations that were once rare are now routine.” Oubre noted the burden is especially serious in cancer care, “where timing and the right treatment are critical. A delay is not an inconvenience. It is a threat to the patient’s outcome.” Read more here.

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