PASTEUR Act reintroduced

Busy Friday: the PASTEUR Act was reintroduced yesterday, and a hearing today will look at the emerging threat of AMR. Plus, six things we’re watching on PBMs and a recap of yesterday’s hearing on patents and IP. (845 words, 4 minutes, 13 seconds)

PASTEUR Act reintroduced

BIO’s long supported the legislation and applauds its reintroduction to help address AMR—here’s what you need to know.

The news: Bipartisan U.S. Senators and U.S. Representatives reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, which would commit $6 billion to reinvigorate innovation in much needed R&D of new antimicrobials.

Why it matters: “Superbugs were linked to almost 5 million deaths worldwide in 2019, making AMR a leading cause of mortality worldwide,” explains BIO’s AMR expert Emily Wheeler. “Unfortunately, the current state of research into antimicrobial treatments is nowhere near where we need it to be to effectively combat the AMR threats we face today, not to mention those that we will inevitably confront in the future.”

How it works: “Under this system, the government would enter into contracts with innovators to pay for consistent access to novel antimicrobials with payments that are decoupled from the volume of antimicrobials used,” says Wheeler.

Who’s behind it: U.S. Sens. Michael Bennet (D-CO) and Todd Young (R-IN), as well as U.S. Reps. Scott Peters (D-CA), Drew Ferguson (R-GA), Mike Levin (D-CA), and Jake LaTurner (R-KS).

BIO’s take: “For decades, we have seen AMR soar around the world, while the pipeline for new treatments slows to a trickle due to the broken ecosystem for antimicrobial innovation. The PASTEUR Act is an integral solution to addressing the global public health crisis of AMR. The bipartisan bill will help repair the foundational challenges of the antimicrobial marketplace and drive the development of new, innovative treatments for patients,” said BIO CEO Rachel King.

What they're saying: BIO issued a joint statement applauding the introduction with the Cystic Fibrosis Foundation, the Infectious Diseases Society of America, the Partnership to Fight Infectious Disease, and The Pew Charitable Trusts—read here. 

Click here to learn more about the superbug outbreaks of 2023.

6 things to watch on PBMs

2023 could be a tough year to be a pharmacy benefit manager (PBM)—here are six things to watch.

What’s happening: Regulators and policymakers are paying closer attention to PBMs—and, in many cases, pushing for reform.

What they’re saying: “I don’t know why the hell they even exist,” said Sen. Jon Tester (D-MT) in a February hearing. “There is no transparency in PBMs. When you combine that with anti-competitive tactics, this is a recipe where the only people who win in healthcare costs are PBMs.”

Here are six things we’re watching:  

1. Markup of the PBM Transparency Act on May 2. “This bipartisan bill would not only put a stop to deceptive and opaque pricing schemes that burden consumers with higher prices, it also saves taxpayers $740 million,” said co-sponsor Sen. Chuck Grassley (R-IA). 
2. Sen. James Comer’s (R-KY) investigation into PBMs. The House Oversight and Accountability Committee Chair launched the investigation in early March, also calling for “greater transparency.”
3. The “Need to Make Insulin Affordable for All Americans” hearing, happening May 10 at the Senate Health, Education, Labor, and Pensions (HELP) Committee led by Sen. Bernie Sanders (I-VT). Three PBM CEOs will testify.
4. Federal Trade Commission (FTC) inquiry into PBMs. The inquiry launched in June 2022, and FTC Chair Lina Khan said April 18 that the FTC is reviewing the study and hopes to share updates “in short order.”
5. Bipartisan framework on PBMs. Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID) announced a plan to release legislative framework to address challenges with PBMs—read more.
6. The PBM Sunshine and Accountability Act. Rep. Diana Harshbarger (R-TN) introduced the legislation on April 25, which would establish new public reporting requirements for PBMs. 

Read more at Bio.News.

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President Biden’s Friday: Presenting the Commander-in-Chief’s trophy to the Air Force Falcons football team, then attending a DNC reception in Washington, D.C.

What’s Happening on Capitol Hill: Yesterday, the House Subcommittee on Courts, Intellectual Property, and the Internet held an oversight hearing on the U.S. Patent and Trademark Office with PTO Director and Under Secretary of Commerce for Intellectual Property, Kathi Vidal. She stressed the importance of the agency’s mission which is to “uphold and protect clear and enforceable IP rights that incentivize innovation and commercial enterprises—whether large or small—and helps to bring that innovation to positive impact, including job growth, higher paying and more stable employment, national security, and solving world problems.”

Members quizzed Director Vidal on PTO’s Request for Comments on PTO Initiatives to Ensure the Robustness and Reliability of Patent Rights and PTO’s Request for Comments on the PTO-FDA Collaboration (to which BIO offered important insights). Members also stressed the importance of ensuring PTO’s work remains transparent and independent of politics. Other questions focused on post-grant patent reviews and the developing law on patent eligibility material. 

Today, we’re watching a House Oversight and Investigations Subcommittee hearing, Antimicrobial Resistance: Examining an Emerging Public Health Threat, which will feature testimony from CARB-X’s Kevin Outterson; we’ll report back on Monday.