What they're saying about PAHPA

What happened during yesterday’s hearing on PAHPA reauthorization? Why are policymakers undermining one of the FDA’s most successful programs? We answer these questions and more. (678 words, 3 minutes, 23 seconds)

Why we need to update the pandemic playbook (and reauthorize PAHPA)

We need to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA)—and ensure we don’t forget what we’ve learned from COVID-19, said bipartisan U.S. Senators and public health officials during a Senate Health, Education, Labor, and Pensions (HELP) hearing yesterday.

Who, what, where: The Senate HELP Committee hearing on pandemic preparedness and PAHPA reauthorization featured testimony from Dawn O’Connell, Assistant Secretary for Preparedness and Response (ASPR) at HHS, CDC Director Dr. Rochelle Walensky, and FDA Commissioner Dr. Robert Califf.

Bipartisan support: Chair Bernie Sanders (I-VT) expressed support for the reauthorization of PAHPA and commended Sens. Bob Casey (D-PA) and Mitt Romney (R-UT) for leading the effort.

What the government wants:

• ASPR: “hiring flexibilities” and procurement authorities and industrial base expansion, due to challenges with hiring and PPE during the COVID-19 pandemic.
• CDC: priorities include improving communications with the American public, data modernization, and “establishing a robust infrastructure for adult vaccination” via the Vaccines for Adults program.
• FDA: supply chain transparency, as well as the creation of a “specialized emerging pathogens program” and extended authority for FDA to receive and respond to surges in demand reported by the industry.

What the industry wants: “This should be the biggest PAHPA reauthorization we’ve had,” Medical Countermeasures Coalition CEO Taylor Sexton previously told Bio.News. “This is the opportunity to take a lot of these lessons learned and institutionalize the statute and make sure that we’re more prepared than we were before. We need to make sure that we don’t let what we’ve already done and learned atrophy.” 

Why it matters: “As we saw during the COVID-19 response, the PAHPA framework is far from perfect,” said Ranking Member Bill Cassidy (R-LA). “We’re here today to ensure a future generation is not forced to learn on the fly should another crisis occur. And we need to update the playbook and ensure our framework is flexible to address threats beyond just a pandemic.”

The next steps: PAHPA expires on September 30, 2023; the legislation needs to be reauthorized every five years.

‘Why are policymakers undermining one of the FDA’s most successful programs?’

BIO CEO Rachel King asks the question in an op-ed for the International Business Times. 

What we’re talking about: accelerated approval, which “expedites the release of new drugs to treat serious conditions,” explains King, such as Alzheimer’s, HIV/AIDS, leukemia, and rare diseases. 

What’s happening: “Unfortunately, several recent federal policy changes have added uncertainty to the accelerated approval program. Without more consistency from the FDA and Medicare, progress toward treating many deadly illnesses could grind to a halt,” continues King.

The impact: Threats to accelerated approval are impacting biotech innovation—especially from small and startup biotechs—and patients. “To have any chance of success, companies need consistent FDA standards and patients need predictable coverage policies,” concludes King. 

Read and share the whole thing.

What you need to know about TB

On Monday, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and Foreign Policy will explore how we can improve pandemic preparedness and especially end TB—here’s why.

By the numbers: “10.6 million people became ill with TB in 2021—a 4.5% increase on 2020—while the incidence rate rose by 3.6% between 2020 and 2021, after declines of 2% per year from the previous two decades,” reports the World Economic Forum.

Why it matters: TB is preventable and treatable—but COVID-19 diverted resources from the TB fight, and for the first time in years, “we saw progress lost in the fight to end TB,” says IFPMA Assistant Director General Greg Perry.

What’s next:Drug-resistant TB is on the rise—a sign of the need to address this infectious disease and others, before it’s too late.

Learn more: On Monday, May 8, IFPMA and Foreign Policy will host a free event—in-person in New York and virtually— Advancing UHC and Pandemic Preparedness, and Ending Tuberculosis. Speakers will include leaders from Johnson & Johnson, Moderna, the World Bank, and more. Click here to register.

President Biden’s Friday: Meeting with his Investing in America Cabinet, which includes key Cabinet members and administration officials focused on areas like the economy, transportation, and energy.

What’s Happening on Capitol Hill: Enjoy the weekend.