Good Day BIO: PDUFA, clean fuels, and cancer care

We packed a lot in today’s issue: BIO's Dr. Cartier Esham testified on PDUFA, the Clean Fuel Standard Act passed the New Mexico Senate, and World Cancer Day highlights the need to address inequity in care. Enjoy the weekend. (889 words, 4 minutes, 26 seconds)

House E&C Subcommittee discusses PDUFA, AMR, and more

The Prescription Drug User Fee Act (PDUFA), antimicrobial resistance, and clinical trial diversity were among topics discussed during yesterday’s marathon hearing on FDA user fee reauthorization—here’s a very quick recap.

The details: The House Energy & Commerce Health Subcommittee held a two-part hearing yesterday, FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics. Witnesses testifying over six hours included the heads of FDA’s Center for Drug Evaluation & Research (CDER) and Center for Biologics Evaluation & Research (CBER), as well as BIO’s Chief Scientific Officer Dr. Cartier Esham.

All witnesses were united in the value of PDUFA,which helps expedite FDA’s drug approval process. Subcommittee Chair Anna Eshoo (D-CA) and Ranking Member Brett Guthrie (R-KY) applauded PDUFA’s role in enabling the approval of 1,700 drugs for patients.

BIO strongly advocated for reauthorization of PDUFA and the Biosimilar User Fee Agreement (BsUFA), citing the important role both play in patient-centric drug development, the Rare Disease Endpoint Advancement pilot, and providing resources for CBER—read Dr. Esham’s full testimony.

More investment in antimicrobial resistance (AMR) is needed. Rep. Morgan Griffith (R-VA) asked, point blank, if there are enough antimicrobial medicines in the pipeline, and CBER Director Dr. Peter Marks said no. Several members brought up the importance of the PASTEUR Act.

Clinical trial diversity is imperative for successful drug development: “We need clinical trials that more closely reflect the diversity of Americans, including those with developmental disabilities," said Committee Republican Leader Cathy McMorris Rodgers (R-WA). Further, just because they may be excluded from trials today, that should also not hurt their access to an FDA-approved drug if their doctor determines that is the best decision for their health.” 

The proposed Aduhelm coverage decision was also discussed, with several Members expressing concern about patient access and BIO citing the impact on future investment in innovation.

Clean Fuel Standard passes NM Senate

The Clean Fuel Standard Act passed the New Mexico Senate yesterday, bringing it one step closer to implementation.

ICYMI: The New Mexico Clean Fuel Standard Act would require a 20% reduction of the carbon intensity of transit fuels by 2030 and a 30% reduction by 2040, through blending renewable fuels, carbon credits, and emissions reductions along the transportation fuel supply chain. 

The latest news: The bill passed the New Mexico Senate yesterday 25-16; it now goes to the New Mexico House of Representatives. 

If implemented, the standard would eliminate an estimated 18.5 million metric tons of emissions—“the equivalent of the tailpipe emissions from driving 570,000 gas-powered vehicles for a year,” wrote three New Mexico Cabinet secretaries in the Santa Fe New Mexican. 

And it would boost the economy: “[W]e’re conservatively estimating that we’re going to get at least 1,600 permanent jobs, 2,300 construction jobs,” said sponsor Sen. Mimi Stewart (D-Albuquerque). “We think we’ll have an additional benefit of $240 million in investment in facilities and infrastructure if we move forward with this bill.”

World Cancer Day highlights need to close the care gap

On World Cancer Day, we celebrate progress—thanks in part to biopharmaceutical innovation—but importantly, note the challenges remaining in ensuring equitable access to cancer care globally.

Cancer is a global epidemic with almost 10 million people dying from cancer each year worldwide, according to the Institute for Health Metrics and Evaluation. 

“Since the War on Cancer began 50 years ago, scientific and technological advancements have contributed to increased cancer survival rates, however disparities still exist in the cancer continuum,” Phylicia Woods, J.D., MSW, Executive Director of the Cancer Policy Institute and Cancer Support Community, told us. 

This year’s World Cancer Day theme is ‘closing the care gap,’ which “aligns with Cancer Support Community’s focus to create solutions to improve health services and outcomes for communities whose members are disproportionately affected by cancer.” 

COVID-19 has added to the challenge. Cancer patients have a higher risk of severe illness from COVID, and the pandemic caused screenings for breast, colon, and cervical cancer to drop by around 94%, 86%, and 94%, respectively, between January-April 2020. 

“The 2022 cancer facts and figures highlight several troubling trends,”including a decline in the slowing prostate cancer mortality rate and a rise in incidence, says Jamie Bearse, President and CEO of ZERO. “The need for more education and access around screening is urgently needed. It’s especially worrisome among Black men who are twice as likely to die from a ‘low risk’ disease.” 

The bottom line: “Everyone deserves a fair opportunity to prevent, find, treat, and survive cancer,” says the American Cancer Society.

3 ways you can take action,per Cancer Support Community:

1. Learn about the importance of cancer detection and the promise of new screening innovation.
2. Share your own story about cancer screening and detection.
3. Ask your Members of Congress to support efforts to detect cancer early.

Did you know? Severe infection and sepsis are the most common reasons why cancer patients are admitted to ICUs, says Pew. Antibiotics play a vital role in cancer care—but the broken antibiotics market puts treatment at risk.  

President Biden’s Friday: Delivering remarks on the January jobs report at 10:45 AM ET. Then, he’ll deliver remarks and sign an executive order at 2 PM ET on Project Labor Agreements, which “will improve timeliness, lower costs and increase quality in federal construction projects.” 

What’s Happening on Capitol Hill: The House could pass the America COMPETES Act, which, as we noted yesterday, currently has an amendment to extend SBIR/STTR. On Monday, Agriculture Secretary Tom Vilsack will provide an update on USDA’s plan to support climate-smart commodities while expanding market opportunities during an event at Lincoln University of Missouri.