Good Day BIO: House passes Ag-FDA spending bill that boosts biotech

It was a busy Wednesday. The House passed the Ag-FDA spending bill, which boosts biotech and innovation. Two U.S. Senators (and Dr. Michelle) discussed how and why we need to tackle antimicrobial resistance. Plus, BIO responded to the Berlin Declaration on vaccine access. (764 words, 3 minutes, 49 seconds)

House passes Ag-FDA spending bill that boosts biotech

The House yesterday passed legislation that would give the FDA the direction and resources to issue guidance on gene-editing in plants—bringing us closer to a watershed in regulation for which BIO has fought for five years—along with several other biotech-friendly measures.

ICYMI: The Fiscal Year 2023 Agriculture, Rural Development, Food & Drug Administration and Related Agencies appropriations bill passed as part of a six-bill minibus spending package. The bill included a bipartisan amendment from Reps. Jimmy Panetta (D-CA) and Jim Baird (R-IN) to direct FDA to "modernize its regulatory process for new products produced through techniques like gene editing."

Other key provisions would:

• Streamline FDA’s review and approval of animal food ingredients, like feed additives that reduce methane in cattle to fight climate change.
• Urge USDA’s Animal and Plant Health Inspection Service to establish a predictable, science-based regulatory pathway for genetically engineered microbes.
• Encourage the National Institute of Food and Agriculture to support non-profit transgenic plant research.
• Provide $16 million for the Agricultural Research Service to leverage current resources to help find solutions to agricultural challenges through biotechnology.
• Require USDA and FDA to collaborate in the development of animal biotech regulations.

BIO’s long advocated for a regulatory system that supports innovation—and in April, outlined priorities for the bill passed yesterday, many of which were adopted.

Why it matters: To enable advances in technology that address climate concerns and ensure food security, we need “transparent regulations that spur biological innovations while protecting health and the environment,” BIO explained.

BIO's view: “The bill passed by the House supports the innovation needed to secure the food supply and advance sustainable technologies that enable farmers and ranchers to help fight climate change,” says BIO’s Chief Policy Officer John Murphy. BIO thanks Reps. Panetta, Baird, and Ashley Hinson (R-IA) for their amendments and urges Senate inclusion of these provisions in the appropriations bill. 

How do we tackle superbugs – before it’s too late?

Antimicrobial resistance (AMR) is already one of the most pressing health challenges of our time—which is why we have to act now to respond, agreed two U.S. Senators and BIO’s Dr. Michelle McMurry-Heath during a virtual event yesterday.

The context: Antimicrobial-resistant infections and deaths increased 15% in hospitals in 2020, the CDC reported last week.

“AMR superbugs are expected to kill more than 10 million people annually by 2050,” said BIO President and CEO Dr. Michelle McMurry-Heath during yesterday’s event, organized by Pfizer and CQ Roll Call. “Unfortunately, there is not an arsenal of antimicrobials to fight resistant infection. The time to develop those new drugs is now, but there are only 64 new antibacterial drug programs in development worldwide.”

In “our flawed antimicrobial market,” drug manufacturers need stronger financial incentives to build the drug pipeline of much-needed, life-saving measures, due to the unique way these products are used, she explained. Companies developing antimicrobials often go broke before—or immediately after—they reach the market, panelists said.

“Right now our system rewards volume not value,” said Sen. Michael Bennet (D-CO). We need a pandemic-style “strategic partnership between biotech and the federal government, which is how we broke every record for vaccine development.”

A solution: The PASTEUR Act, co-sponsored by Sen. Bennet and Sen. Todd Young (R-IN), which “would create a subscription-style model” whereby the government pays drug developers “based on a treatment’s value to public health,” Sen. Young said. The House bill, sponsored by Rep. Mike Doyle (D-PA) and Drew Ferguson, DDS, (R-GA), reached 60 cosponsors this week signaling that the support to urgently tackle AMR is growing.

Watch Dr. Michelle’s segment:

Want to know more?Check out this Medical Minute with Rep. Greg Murphy, M.D. (R-NC) discussing AMR.

More Health Care News: 

BIO: Berlin Declaration will ‘save lives’ in the future
“The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) this week released the ‘Berlin Declaration’—a framework to work with G7 and G20 on a joint solution for better access to vaccines and treatments around the world for future pandemics,” explains BIO. “Adopting these principles now will no doubt save lives in the future—especially those in underserved areas of the world—by ensuring quick and equitable distribution of innovative vaccines and therapeutics,” said BIO’s Dr. Michelle McMurry-Heath. 

IQVIA: Disparities in Medicare Access for People Under 65 Living with ALS
“For many patients with ALS who are under the age of 65, enrollment in Medicare can provide much-needed coverage; however, for this group of individuals, the coverage may still come with prohibitive out-of-pocket costs that can delay access to therapy or other types of care.”

President Biden’s Thursday: Giving a speech in Wilkes Barre, PA, about the Safer Communities Act, bipartisan gun legislation, before participating in a DNC fundraiser in Philadelphia. Meanwhile, the Biden administration is “creating a new division within the Department of Health and Human Services to coordinate the nation’s response to pandemic threats and other health emergencies,” reports The New York Times.

What’s Happening on Capitol Hill: The House Committee to Investigate the January 6th Attack will hold what was intended to be its last hearing, though more hearings may be scheduled, POLITICO reports.