Good Day BIO: Pass PASTEUR – before time runs out

The “lame-duck” Congress begins, and BIO’s calling for passage of the PASTEUR Act before the end of the year. Plus, a new study finds that state proposals to limit access to Accelerated Approval drugs would harm patients. (786 words, 3 minutes, 55 seconds)

Why the Congress must pass the PASTEUR Act

BIO joined more than 150 health-focused organizations in signing a letter to congressional leaders yesterday urging passage of the PASTEUR Act before the current congressional session ends on Jan. 3.

The PASTEUR Act—a.k.a. the Pioneering Antimicrobial Subscriptions To End Up-Surging Resistance Act—targets antimicrobial resistance (AMR), “one of the greatest public health threats of our time,” according to a statement announcing the letter.

How it would work: The PASTEUR Act would establish an outcomes and value-based alternative payment model where the government pays companies set amounts for critical-need antimicrobials based on a treatment's value to public health. This model would be designed to provide a predictable return for companies, enabling them to continue innovating while incentivizing investments to support a more robust R&D pipeline. This new payment model would align market forces with public health realities by decoupling value from overall volume, with a  “strategic partnership between biotech and the federal government,” explained Senate Democrat lead Sen. Michael Bennet (D-CO).

The bill is popular—with nearly 70 bipartisan co-sponsors across the House and Senate bills and its principles are supported by Health and Human Services (HHS) Secretary Xavier Becerra.

But time is running out before the 117th Congress ends—and Democrats have a “long to-do list” during the lame-duck session before Republicans take over the U.S. House.

The PASTEUR Act belongs on the lame-duck agenda: “Delays in passing the PASTEUR Act are delays in developing novel antimicrobials to treat highly resistant, life-threatening infections,” says the letter, “delays that many patients … cannot afford.”

Why it matters: Without action, AMR is projected to kill 10 million per year by 2050. We need new antimicrobials, but the market is broken, with fewer than 70 antimicrobial programs in the pipeline. The PASTEUR Act would drive and sustain investment into a diverse pipeline of AMR products to ensure clinicians and patients have the drugs we need to address current and future resistant threats.

To learn more—listen to the I am BIO podcast, Antimicrobial Resistance: The Silent Pandemic.

Take Action: Help fight superbugs by asking your Member of Congress to pass the PASTEUR Act now.

Limiting Accelerated Approval would have human cost, says new report

Plans to limit FDA’s Accelerated Approval (AA) pathway would reduce the number of new treatments hitting the market, especially drugs for rare diseases, says a study released Tuesday.

The key finding: State-level proposals to delay Medicaid coverage of AA therapies would negatively impact between 66,000 and 319,000 patients, and provide minuscule savings, finds the study from Vital Transformation.

Accelerated Approval addresses unmet need, especially rare disease. Treatments can enter the market before final clinical trials, IF earlier trials show effectiveness against a “surrogate endpoint,” indicating the drug probably works. Effectiveness must then be confirmed by phase 3 trials, which can happen after the drug is on the market.

75% of these drugs “have their evidence pack and are approved by the FDA within four years,”said Duane Schulthess, CEO of Vital Transformation, which examined all 206 drugs that received or await confirmation since the pathway was established in 1992. The few trials taking more than five years generally involve drugs for rare diseases with small populations, which can delay trials.

But states are trying to limit access, with proposals to block, delay, or reduce Medicaid reimbursement for Accelerated Approval drugs. These drugs only account for 0.5% of the average state Medicaid budget.

The big picture: Limiting the Accelerated Approval pathway would particularly impact patients living with rare disease and “could render the development of those therapies economically untenable,” says the study.

Read more and watch our exclusive interview on Bio.News.

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President Biden’s Thursday: No public meetings scheduled after international travel.

What’s Happening on Capitol Hill: House Speaker Nancy Pelosi is expected to announce future plans today after Republicans won control of the House following the election of Rep. Mike Garcia in California’s 27th District. The Senate is expected to advance toward a vote to protect same-sex and interracial marriage. The Senate Energy & Natural Resources Committee will consider Department of Energy appointments, including Jeffrey Marootian for Assistant Secretary of Energy Efficiency and Renewable Energy.