BIO experts have been analyzing the fiscal 2023 omnibus spending bill. Here are some preliminary takeaways on measures impacting the biopharma industry:
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.
BIO’s take: 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 is tasked with producing a briefing on a timeline for commercialization, possible costs, and market competition rules.
Provisions inspired by the proposed PREVENT Pandemics Act:
- The CDC director would have 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 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.
Advanced Research Projects Agency for Health (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.
BIO’s take: “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 the inclusion of provisions from the PREVENT Pandemics Act. …We look forward to building on these efforts in 2023 through the reauthorization of the Pandemic and All-Hazards Preparedness Act.”
What’s next: 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.