Good Day BIO: FDA's clinical trial guidance and a long-awaited USDA nominee

D.C.’s in recess, but there’s a lot happening. We have a look at BIO’s recent comments on FDA’s clinical trial diversity guidance, a long-awaited USDA nominee, and why Accelerated Approval is under political attack. (772 words, 3 minutes, 51 seconds)

BIO comments on FDA clinical trial guidance, USDA nominee

While D.C.’s officially in recess, let’s catch up on recent BIO comments on clinical trial guidance and a long-awaited USDA nominee. 

First: FDA’s clinical trial diversity guidance. On April 13, the FDA published new draft guidance for industry on “developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.”   

BIO provided “two key overarching recommendations” for improving the guidance, in comments submitted earlier this month:

1. Patient and community engagement/building trust: “BIO proposes that the Agency ensures that they have the necessary expertise to be able to address concerns related to enrolling and retaining diverse patients (i.e., site operations, community engagement strategies and reducing burdens to trial/study design and conduct).”
2. FDA-sponsored communication and engagement: “Specifically, it would be helpful to provide more clarity on the timing and operational aspects of FDA’s expected review of the Diversity Plan,” building from provisions described in the PDUFA VII commitment letter.

BIO addressed several other issues, too—including the importance of collecting and analyzing data by “self-assigned” or “self-reported” race and ethnicity to address socio-cultural issues contributing to underrepresentation, and how data collected globally could be used.

Read: BIO’s comments on the FDA guidance on clinical trial diversity 

Second: BIO supports the nomination of Alexis Taylor for USDA Under Secretary for Trade and Foreign Agricultural Affairs,joining dozens of food and agriculture groups in a letter to Senate Agriculture Committee leadership. 

Who is Alexis Taylor?Currently Director of the Oregon Department of Agriculture, Taylor was raised on an Iowa farm and has had a long career in public service, including at USDA, making her “uniquely qualified for this role.” 

Why it matters: Her nomination to the “long-vacant role” comes “as the Biden administration is struggling to address the fast-spreading global food insecurity fallout from Russia’s war in Ukraine,” POLITICO reported in May. 

Read: BIO’s letter supporting Alexis Taylor

More News: 

The Wall Street Journal: Ethanol keeps climbing as gasoline prices stay high
“The price of ethanol, the corn-based fuel that is a common gasoline additive, has risen 14% so far this quarter, outpacing crude oil.”

Accelerated Approval is under political attack, experts say

The FDA’s Accelerated Approval pathway has helped America’s biotech industry achieve remarkable advances in the last 30 years—but it’s been under political attack, putting potential cures at risk, said experts in a Vital Health podcast episode recorded at last week’s BIO International Convention. 

What is Accelerated Approval? Established in the 1990s to encourage R&D for HIV/AIDS, Accelerated Approval facilitates FDA approval for drugs that address serious conditions with no treatments. 

“50% of all therapies created over the last 10 years originated in small us biotech companies”—thanks to policies like Accelerated Approval, said podcast host Duane Schulthess, CEO of Vital Transformation, which analyzes the economic impact of treatment pathways and biopharma innovation. 

What’s the problem? Earlier this year, Centers for Medicare and Medicaid Services (CMS) chose to severely limit coverage for a new Alzheimer’s drug, effectively second-guessing the FDA and the pathway. 

CMS “found the Accelerated Approval process a convenient objective whipping boy” to blame for budgetary problems caused by the pandemic and other structural challenges, John A. Murphy, III, BIO’s Chief Policy Officer and Deputy Counsel, said on the podcast. 

If the pathway is restricted, many life-saving treatments would never reach patients,found research released by Vital Transformation at the BIO International Convention. 

Accelerated Approval supports a robust U.S. biotech industry—which exists “due to policy that rewards innovation,” said Nick Shipley, BIO EVP and Chief Advocacy Officer. “It is a strategic asset. It is a healthcare asset that is of great benefit to this country.”

Listen to the podcast.

President Biden’s Monday: He’s in Germany for the G7, where leaders yesterday launched the Partnership for Global Infrastructure and Investment, which will “close the infrastructure gap in developing countries, strengthen the global economy and supply chains, and advance U.S. national security.” Today, he’s already participated in a session on Ukraine and a working lunch on climate, energy, and health. He’ll also join a plenary with outreach partners and international organizations on food security and gender equality.

What’s Happening on Capitol Hill: While Congress is officially in recess for the July 4 holiday, health policy will remain in focus in the wake of the Supreme Court’s decision to overturn Roe v. Wade. POLITICO looks at 18 ways the decision changed America. The Supreme Court could now turn to climate policy, as it is expected to decide a case on “what powers the Environmental Protection Agency (EPA) has to regulate climate change,” explains The Hill. Meanwhile, the FDA’s vaccine advisory committee will meet Tuesday to discuss vaccines for COVID variants.