Good Day BIO: FDA user fee agreements advance with bipartisan support

House Energy and Commerce marked up legislation to reauthorize FDA user fee agreements yesterday—here’s a recap. Plus, the UNCCD is talking about food systems today, and we explain why biotech solutions should be on the menu. (619 words, 3 minutes, 5 seconds)

FDA user fee agreements advance with bipartisan support

The House Energy & Commerce Health Subcommittee yesterday marked up six bills addressing FDA user fee agreements and other health priorities—here’s what you need to know. 

What happened:The Food and Drug Amendments of 2022 (H.R. 7667) passed out of committee with a bipartisan vote of 30-0. In addition, the subcommittee advanced the Advanced Research Project Agency-Health (ARPA-H) and legislation related to mental health, pediatric research, and South Asian heart health awareness.

The key takeaway: There’s bipartisan support for reauthorizing the FDA user fee agreements, which committee and subcommittee leadership from both parties agreed are critical to ensure drugs are safe and effective and speed lifesaving innovations to patients.

Watch:

Accelerated approval came up, with the Committee Republican Leader Cathy McMorris Rodgers (R-WA) saying the bill “preserve[s] the promise and the hope of the Accelerated Approval Pathway and what it brings to patients and their families while ensuring [post-approval studies] are conducted in a timely manner.” 

The specifics: The bill “would strengthen the FDA’s power to ensure there are clear conditions for completing confirmatory trials and gives regulators the authority to require studies to be underway before approval is granted,” reports Axios. The bill also “clarifies conditions under which the FDA could withdraw an accelerated approval and adds labeling requirements for drugs that go through the process.”

The legislation would also ensure “clinical trials are inclusive and representative of the patients that sponsors intend to serve,” said Committee Chair Frank Pallone (D-NJ).

The next steps: The bills are expected to be part of a full committee mark up next week.

BIO’s take: BIO appreciates the package and looks forward to its advancement, as FDA is “critical to advancing innovation,” as BIO’s Chief Scientific Officer Dr. Cartier Esham testified earlier.

More Reading: House unveils package to reauthorize FDA user fee agreements

It’s Food Day at UNCCD COP15 – here’s why biotech should on the menu

Biotechnology can help us address our food and land challenges and ensure a sustainable, healthy food supply and planet for future generations.

What’s happening: The 15th Conference of the Parties (COP15) of the UN Convention to Combat Desertification (UNCCD) is underway in Côte d’Ivoire through May 20, bringing together governments, civil society, and business to discuss sustainable management of land.

Today’s all about food—specifically, to “build momentum for transforming food systems” and include food systems in discussions related to climate change, biodiversity, and land degradation.  

Why talk about food? We’ll need to feed 10 billion people by 2050, so we must ensure our food supply is both nutritious and resilient in the face of climate change. But agriculture accounts for about 30% of global greenhouse gas emissions and 80% of land-use changes.

This is why biotech must be on the menu—including cutting-edge tools like gene editing to develop rice that’s more nutritious, salmon which grows to market weight with less inputs, and crops that better tolerate heat and drought, as well innovative farming methods to improve soil health and capture carbon.

BIO is taking action on food systems—joining the Agriculture Innovation Mission for Climate (AIM), which is driving climate-smart agriculture and food system innovation, and the Coalition for Sustainable Productivity Growth for Food Security and Resource Conservation, which is accelerating the transition to more sustainable food systems through ag productivity growth.

Learn more about Food Day at UNCCD COP15.

President Biden’s Thursday: Meeting with leaders of the Association of Southeast Asian Nations (ASEAN) countries, followed by dinner at the White House.  

What’s Happening on Capitol Hill: The Women’s Health Protection Act failed to pass the Senate yesterday. Today, the Senate will consider a Ukraine aid package, while budget hearings continue. Additional hearings will cover forest conservation in the fight against climate change and the health and wellbeing of older adults.