Good Day BIO: Oregon wants to restrict access to accelerated approval drugs – take action now

Oregon has proposed a plan to restrict coverage of accelerated approval drugs—here’s why that’s a bad idea (and what you can do about it). Today, we’re watching BIO’s Dr. Cartier Esham testify on FDA user fee agreements, and BIO member Gevo testify on renewable energy opportunities in the farm bill. (803 words, 4 minutes)

Oregon wants to restrict access to accelerated approval drugs – here's how you can take action

The state of Oregon is proposing to restrict coverage of medicines approved under FDA’s Accelerated Approval Pathway—here’s what’s happening and how you can take action.

ICYMI: The Oregon Health Authority is proposing sweeping changes to its Medicaid program, including excluding drugs approved via FDA’s Accelerated Approval Pathway from coverage—instead using its “own rigorous review process to determine coverage of new drugs and to prioritize patient access to clinically proven, effective drugs.”

“We urge CMS to reject those provisions of the proposed waiver that would exacerbate health disparities and jeopardize patient access and care, especially for patients with rare and chronic diseases,”said BIO in comments to CMS.

Furthermore: The proposal undermines the FDA’s authority to determine which drugs are safe and effective—and violates the Social Security Act, BIO's comments explain.

Take action: Oregon’s proposal is currently under review by the Centers for Medicare and Medicaid Services (CMS)—and it's time for the biotech industry and stakeholders to weigh in.

BIOAction: Click here to urge CMS to reject this proposal and explain why it would harm patients, especially those with serious, unmet need. 

More Reading:“This is not the time to retreat on accelerated approval,” said BIO’s Dr. Michelle McMurry-Heath during JPM in January.

More Health Care News: 

The Wall Street Journal: Antibiotics venture fund makes its first two investments
“AMR Action Fund plans to invest $1 billion in startups fighting antibiotic-resistant bugs. Its first bets are on Venatorx and Adaptive Phage.”

‘A farm bill centered on innovation’

Such legislation could benefit the environment and rural economies—but requires strengthening the BioPreferred® Program and measuring GHG emissions, says BIO ahead of a hearing on the farm bill and renewable energy opportunities.

What’s happening: The House Agriculture Committee will hold a hearing today, A 2022 Review of the Farm Bill: Renewable Energy Opportunities in Rural America. Witnesses include Under Secretary of Agriculture for Rural Development Xochitl Torres Small and Dr. Patrick Gruber, CEO of Gevo, the BIO member producing zero-carbon fuel.

“A farm bill centered on innovation stands to incentivize the adoption of cutting-edge technologies and practices, resulting in benefits to the environment and rural economies,” says BIO’s statement submitted for the record. “Further, supporting biobased technologies, such as sustainable fuels, renewable chemicals and biobased manufacturing is crucial to agriculture being part of the solution to the climate crisis and fostering energy security.”

The farm bill should strengthen the BioPreferred® Program, which directs federal agencies to purchase and use renewable chemicals and biobased products. BIO calls for “significant mandatory funding and enforceable procurement requirements,” and educating procurement officers about benefits.

“Infrastructure to measure and verify reductions in emissions and carbon sequestrations at the local farm level” is also key,continues BIO. “This will also require both modeling and regulatory requirements for greenhouse gas emissions analysis for sustainable fuels and renewable chemicals to reflect the newest science and technology.”

“We have the ability and technology to produce net-zero footprint fuels,” says prepared testimony from Gevo’s Dr. Gruber. But we need to replace fossil-based energy, as well as account for, audit, and report the entire lifecycle “from field to combustion.”

“The GREET model is the go-to standard,” he continues. “Going forward we think it is important for additional harmonization of models and data for counting carbon,” and “program funding for measuring carbon.” 

BIO agrees and made the same point in our letter to EPA on GHG modeling, which we highlighted yesterday. A bipartisan group of Senators led by John Thune (R-SD) and Amy Klobuchar (D-MN) also made a similar request in their own letter to EPA, asking that the agency "utilize the GREET Model as the baseline GHG determination for biofuels..."

Spring cleaning and need another podcast? Listen: Dr. Gruber joined the I am BIO Podcast to discuss Gevo’s technology.

More Agriculture and Environment News:

Gevo: Company will partner with Farmers Edge to verify sustainable fuels through Verity Tracking
This collaboration is expected to support the sustainable development & full carbon lifecycle tracking of a carbon intensity (CI) score from low-carbon grain through renewable fuels production. 

Twist Bioscience: Twist Bioscience and Ginkgo Bioworks sign new collaboration
“One of the world’s largest DNA supply agreements”—between two BIO member companies—“enables diverse product development across multiple industries.”

President Biden’s Tuesday: At 1:30 PM ET, delivering remarks alongside former President Obama on the Affordable Care Act, where he’s expected to announce changes “that would make more people eligible for premium tax credits to buy ACA marketplace plans,” per NBC. The White House COVID-19 Response Team and HHS officials will hold a briefing at 3 PM ET.

What’s Happening on Capitol Hill:BIO’s Chief Scientific Officer Dr. Cartier Esham will testify before the Senate HELP Committee on FDA user fee agreements—we’ll recap tomorrow. We’re also keeping an eye on the House Agriculture Committee hearing on renewable energy opportunities in the farm bill, as well as HHS Secretary Xavier Becerra’s appearance before the Senate Finance Committee.