From 'death sentence' to cure

BIO and bipartisan policymakers highlighted how policy can support—or thwart—cancer innovation. Plus, BIO explains why a proposed federal rule should recognize the benefits of genetically engineered organisms (GEOs) to National Wildlife Refuges. (607 words, 3 minutes, 2 seconds)

From ‘death sentence’ to cure, with biotech innovation

During The Hill’s panel discussion last week, The Future of Cancer Care, policymakers and experts highlighted significant strides in cancer treatment—and the role of policy in supporting (or thwarting) innovation.

Why it matters: By 2050, the number of people worldwide with cancer could rise 77%, with 1 in 5 people alive today expected to develop cancer in their lifetime, according to a recent American Cancer Society report.

“Five years ago, metastatic melanoma was often a death sentence,” said Rep. John Joyce, M.D. (R-PA), a dermatologist. “Now, diseases like metastatic melanoma are curable with the treatments that have developed since I came to Congress—not because of what I did in Congress, but because of the innovation and research that industry continues to do.”

We need to “remove those drugs that are successful for treating multiple diseases…from the Medicare price negotiations, so that we can continue to see that innovation extend into other arenas,” continued Rep. Joyce. “We want to see that investment occur in research and development. And the only way that we can see that being successful is with a minor modification, a minor tweak, if you will, to the IRA.”

The Cancer Moonshot is a priority, said Rep. Wiley Nickel (D-NC), who lost his father to cancer: “We have the resources to do it. We need to make those investments.”

“Innovation without universal access is insufficient,” said BIO President & CEO John F. Crowley. “Let’s identify and break down barriers to access.” He called for passage of the ORPHAN Cures Act and EPIC Act to fix the small molecule “pill penalty,” as well as find a way to address out-of-pocket costs in oncology.

The bottom line: “In the last 10 years in oncology, we’ve had 133 new medicines approved—14 last year,” continued Crowley, citing cancer innovations from CAR T to gene therapy, vaccines, and mRNA. “That’s good, but it’s not enough.”

Watch and share highlights from John F. Crowley’s remarks:

Fish and Wildlife Service needs science-based rules on GE organisms, BIO says

A federal rule that purports to uphold science should not restrict planting of genetically engineered organisms (GEOs) on to National Wildlife Refuges-System lands, BIO argued in May 6 comments.

The U.S. Fish and Wildlife Service (FWS) proposed rule for ensuring “Biological Integrity, Diversity, and Environmental Health” in national wildlife refuges includes regulation of cooperative farming in refuges. BIO responded to the FWS invitation for comments.

Conflicting language: “Refuge Managers must use the best available scientific information to inform their sound professional judgment,” says the rule. But it goes against science, saying “GEOs can have unpredictable and unintended effects on species and ecosystems,” according to BIO’s comments.

“GE organisms have been found to be as safe as their conventional counterparts” with “rigorous science-based rulemakings and analyses” of the U.S. Department of Agriculture, Food and Drug Administration, and Environmental Protection Agency, outlined in the Coordinated Framework for the Regulation of Biotechnology, explained BIO's comments. Cooperative farming—using GEOs provide habitat for wildlife and help control weeds that can fuel wildfires.

“The Proposed Rule is further untethered from Executive Order 14081 and the National Security Commission on Emerging Biotechnology Interim Report, which encourage a science- and risk-based regulatory scheme that supports advances in biotechnology,” the comments continued.

The bottom line: “The Proposed Rule would impose unnecessary rigidity that is contradicted by the comprehensive risk-based scientific analyses conducted by other federal agencies and limits refuge managers’ options to use all resources at their disposal to preserve National Wildlife Refuge Lands.”

President Biden’s Tuesday: Delivering remarks at the 30th annual awards gala of the Asian Pacific American Institute for Congressional Studies.

What’s Happening on Capitol Hill: The House is expected to take up the long-awaited Federal Aviation Administration (FAA) reauthorization bill.