Good Day BIO: Oregon drops plan to limit Accelerated Approval

Today, we have good news from Oregon on Accelerated Approval, and what USDA’s doing to advance ag biotech in response to climate change. Meanwhile, we’re awaiting news from Capitol Hill regarding the reauthorization of SBIR/STTIR and PDUFA any moment now, with passage of both expected before the Sept. 30 deadline. (764 words, 3 minutes, 49 seconds)

Oregon drops plan to limit FDA Accelerated Approval

FDA’s Accelerated Approval pathway, which gets patients quicker access to new drugs, will not be affected by the Medicaid waiver approved in Oregon yesterday—a win for BIO, biotech innovation, and the people of Oregon.

A few good ideas: When it sought a 1115 waiver to alter the way Medicaid is administered in the state, the Oregon Health Authority added provisions to the state’s Medicaid policy designed to address healthcare inequity and ensure broader coverage, especially for low-income Oregonians.

One bad idea: Oregon’s original waiver application would have limited Medicaid coverage for drugs made available through FDA’s Accelerated Approval pathway, instead allowing the state to conduct its “own rigorous review process to determine coverage of new drugs and to prioritize patient access to clinically proven, effective drugs.”

Fortunately, the provision limiting coverage for Accelerated Approval drugs has been removed, with Oregon’s 2022-2027 1115 waiver approved without it yesterday.

Accelerated Approval is essential: The pathway allows market entry for medications that address critical illnesses with no therapies, based on clinical trials that indicate effectiveness with “surrogate endpoints”—as long as later clinical trials confirm effectiveness. Accelerated Approval has facilitated hundreds of drugs for HIV/AIDS, cancer, and rare diseases, permitting lifesaving treatments, and saving money and lives, a recent report details.

BIO pushed hard to preserve Accelerated Approval in Oregon, through state-level and virtual advocacy and urging the U.S. Centers for Medicare & Medicaid Services (CMS) to preserve Accelerated Approval in the state.

The next steps: Oregon is spared—but future state and federal action may target Accelerated Approval. BIO will continue to work to protect it.

 

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Ag productivity is down due to climate – but USDA and biotech are on it

Climate change poses increasing challenges to food production and supply chains. USDA is working to advance initiatives to drive agricultural biotech innovation and deployment worldwide, said experts during a BIO-sponsored webinar yesterday. 

The problem: “Global agricultural productivity growth is on average 21% lower than it would have been without climate change,” said Elise Golan, Director, Sustainable Development at USDA’s Office of the Chief Economist. “This is equivalent to losing about seven years of farm productivity increases since the 1960s.”

And it’s getting worse: “The IPCC projects that as much of 30% of agricultural land worldwide could become unsuitable for farming in the coming decades,” she said.

Biotech innovations are impactful and have great potential—but they’re getting much less attention and less investment than wind and solar, explained Jaime C. Adams, a senior policy advisor at USDA.

A few international initiatives can drive investment in ag tech:

• The Agriculture Innovation Mission for Climate (AIM for Climate), which came out of COP26 in October, focuses on “empowering agriculture innovation to address the climate crisis,” said Adams, by bringing “agriculture to the table.”
• The Sustainable Productivity Growth Coalition, launched by the U.S. at UN Food Systems Summit last fall, seeks to optimize ag sustainability across social, economic, and environmental dimensions. The coalition has been engaged in global “messaging to convey the importance of sustainable ag productivity growth,” said Cathy McKinnell, a USDA senior policy advisor on trade and geographic affairs.

Did you miss the discussion? Watch the highlights.

More Agriculture and Environment News:

EPA: EPA Administrator Regan launches new national office dedicated to advancing environmental justice and civil rights
“EPA’s historic Office of Environmental Justice and External Civil Rights will position the agency to better advance environmental justice, enforce civil rights laws in overburdened communities, and deliver new grants and technical assistance.” 

President Biden’s Thursday: Hosting leaders involved in the U.S.-Pacific Island Country Summit, which includes a promise of $860 million in expanded programs from the United States, according to Reuters. Earlier, receiving a FEMA briefing on Hurricane Ian.

What’s Happening on Capitol Hill: With Sen. Joe Manchin agreeing to removal of his energy provision, the stopgap spending bill is expected to pass today or tomorrow, ABC reports. SBIR/STTR continuation was discussed yesterday but tabled, and is expected to be put for a vote today. A hearing by the House Committee on the Climate Crisis will examine how the Inflation Reduction Act will lower utility bills, create jobs, and expand investment in the manufacturing of climate solutions.