Good Day BIO: Does FDA question the Aduhelm decision?

Senators questioned FDA officials yesterday—here’s what FDA said about the CMS Aduhelm decision. Also, BIO member BASF opened a new Center for Sustainable Agriculture to highlight biotech innovations. (612 words, 3 minutes, 3 seconds)

Does FDA question the Aduhelm decision?

Senators asked this question (and more) of key FDA leadership during yesterday’s Senate HELP hearing on the role of FDA user fee agreements in advancing medical product regulation and innovation—here’s what you need to know.

To catch up: “CMS is saying that in order to cover a drug that FDA has determined as safe for marketing, more safety data needs to be generated,” said Sen. Susan Collins (R-ME), speaking critically of the Aduhelm decision.

“Do you question the FDA’s decision-making regarding Aduhelm’s accelerated approval?” she asked Dr. Patricia Cavazzoni, Director of FDA’s Center for Drug Evaluation and Research (CDER).

The FDA is “committed to continuing to utilize” accelerated approval, Dr. Cavazzoni responded. “We believe the data are solid and the drug is appropriately made available to patients,” but it’s “important to distinguish FDA’s role and CMS’s role.”

“What concerns me is not FDA’s approach, you stayed within your lane,” said Sen. Collins. “But CMS did not, because CMS commented not just on reasonableness and the cost, but on the safety…I fear it will discourage research and have an impact on the pipeline.”

It will “crush capital markets” for drug R&D, explained Ranking Member Richard Burr (R-NC): “When we have innovation like that…and we do an approval at FDA, and CMS then limits the people it would be applicable to…they have just crushed the capital markets that financed the development of that drug.”

The hearing covered other topics too—including therapeutic equivalence evaluations for 505B2 new drug applications and orphan drug exclusivity. Watch the whole thing.

BASF’s Center for Sustainable Agriculture highlights biotech solutions

BASF opened its new Center for Sustainable Agriculture Monday—and Sarah Gallo, BIO’s VP of Agriculture and Environment, was on the scene to visit the BIO member’s new digs. 

The largest chemical producer in the world, BASF develops “chemistry for a sustainable future” including chemicals, materials, and ag solutions like biological crop protection and solutions for soil management and pest control.

What will the center do? Located in Research Triangle Park, NC, the Center for Sustainable Agriculture features interactive exhibits highlighting BASF’s products and initiatives, including a garden with plants benefiting from the ag products.

What they’re saying: “The world is putting more pressure on our farmers, and they’re not getting as much support as they need to meet the demands and the challenges they face on a daily basis,” said Paul Rea, Senior Vice President, BASF Agricultural Solutions North America. This “demonstrates that we’re at the forefront of providing farmers with some much-needed support. It also will help us to amplify their voices within and outside of our agricultural food system."

Why it matters:Food insecurity and pest-driven disease, skyrocketing energy prices, increasingly unhealthy air—it’s clear we need sustainable solutions to tackle these challenges and whatever comes next for agriculture and the planet. Biotech is delivering.

Photos by Sarah Gallo

More Agriculture and Environment News: 

Elanco: Elanco and Royal DSM announce strategic alliance to develop methane-reducing cattle feed
Elanco Animal Health Incorporated and Royal DSM will “develop, manufacture and commercialize” Bovaer® for beef and dairy cattle. “Bovaer® is a first-in-class methane-reducing product for beef and dairy cattle approved in Europe, Brazil, Chile and Australia.”

President Biden’s Wednesday: Delivering remarks at the funeral of former Secretary of State Madeleine Albright. Former President Bill Clinton and his wife, former Secretary of State Hillary Clinton, will also speak, CNN reports. In the afternoon hosting the Council of Chief State School Officers’ 2022 National and State Teachers of the Year, with Kurt Russell, teacher of the year.

What’s Happening on Capitol Hill: The House Subcommittee on Health, of the Committee on Energy and Commerce, will hold a hearing on the 2023 budget for the Department of Health and Human Services, with testimony from Secretary Xavier Becerra.