The text of the 4,155-page, $1.7 trillion omnibus spending bill was delivered around 2 a.m. Tuesday. According to POLITICO, the Senate is “scrambling” to pass the bill before the holiday recess; the bill needs to pass the Senate and the House before midnight on December 23. The Senate appears to have enough votes to send the bill to the House, where the Democratic majority is expected to pass it for President Biden’s signature by Friday, CNN says.
Biotechnology Innovation Organization (BIO) experts have been analyzing the bill and what it means for the biotech sector, including both biopharmaceuticals as well as agriculture and environment companies. Here’s what we know so far.
U.S. Food and Drug Administration (FDA)
- FDA is tasked with developing Accelerated Approval (AA) reforms; labeling AA products is not required.
- Provisions promote clinical trial diversity.
- “Platform” technologies for drugs and vaccines.
- A new review pathway for designating advanced manufacturing technologies.
The bill contains policies originally considered during User Fee Agreement negotiations.
“BIO advocated to ensure that the Accelerated Approval pathway can continue to work as intended,” says BIO’s Chief Scientific Officer, Cartier Esham. “We were also pleased to see our efforts rewarded as reflected in various provisions such as clinical trial modernization and diversity, and advanced and innovative manufacturing technologies.”
Commercialization of COVID-19 vaccines
As the federal government begins to curtail its role as the exclusive purchaser of COVID-19 vaccines, Health and Human Services (HHS) is tasked with producing a briefing on a timeline for commercialization, possible costs, and market competition rules.
ARPA-H and pandemic prevention
The new ARPA-H receives $1.5 billion and new authority through the Public Health Service Act. New provisions cover location, governance, reporting requirements, collaboration with FDA, and appointment of the director (without Senate confirmation). The agency would focus on technology and have $500 million in funding for FY2024-28.
In addition, the bill contains several provisions inspired by the proposed PREVENT Pandemics Act, which BIO supported. These include:
- The Centers for Disease Control and Prevention (CDC) director would need to be confirmed by the Senate; CDC would produce four-year plans and add an Advisory Committee.
- Establishment of a White House Office of Pandemic Preparedness Response Policy.
- Biomedical Advanced Research and Development Authority (BARDA) could enter into contracts to support manufacturing surges.
- HHS could contract vendors to manage Strategic National Stockpile inventories.
- Strengthened surveillance and data sharing on pathogens.
- Additional oversight of federally funded research of enhanced pathogens with a pandemic or national security potential.
- Study on incentives for domestic production of generic drugs.
- Domestic antibiotics production grants through Administration for Strategic Preparedness and Response for certain antibiotics with identified supply chain vulnerabilities.
- Further provisions to enable rapid development and testing of drugs.
“BIO is pleased to see increased funding for key public health and pandemic preparedness priorities, such as ASPR, BARDA, and the Strategic National Stockpile,” says Phyllis Arthur, BIO’s VP for Infectious Disease and Emerging Science Policy. “We were also encouraged by including provisions from the PREVENT Pandemics Act. …We look forward to building on these efforts in 2023 by reauthorizing the Pandemic and All-Hazards Preparedness Act.”
U.S. Department of Agriculture (USDA)
The bill includes provisions BIO supported in the House appropriations bill in July, including:
- USDA’s Animal and Plant Health Inspection Service should work to establish a predictable, science-based regulatory pathway for genetically engineered microbes.
- $16 million for the Agricultural Research Service toward finding agricultural biotechnology solutions.
- USDA and FDA collaborate on regulations regarding the movement of animals modified or developed by genetic engineering.
But BIO’s sorry to see an omission: a House plan to support the FDA in issuing guidance on new plant varieties produced through genome editing.
The bill combines two beneficial environmental proposals:
- The Growing Climate Solutions Act establishes USDA regulation of carbon credits so farmers fighting climate change can reap the rewards of carbon markets. BIO has long backed this legislation.
- The House SUSTAINS Act allows private entities to fund conservation projects and authorizes matching donations from USDA.
Energy Efficiency and Renewable Energy (EERE)
EERE would receive $3.46 billion, a historic level of funding, with $280 million for EERE’s Bioenergy Technology Office to fund R&D on converting biomass into clean, renewable fuels, chemicals, and products.
The spending bill also supports using carbon dioxide from production plants, such as biorefineries, to produce higher-value fuels, chemicals, or materials.
“BIO welcomes the omnibus’ inclusion of many provisions from the House-passed agricultural appropriations bill that help biotech developers and their farmer and rancher partners meet 21st-century challenges through innovation. We are also pleased the bill increases funding for the Bioenergy Technology Office,” says Beth Ellikidis, BIO’s VP for Agriculture and Environment. “BIO applauds Congress for working in a bipartisan manner to pass the Growing Climate Solutions Act with its inclusion in this legislation.”