FDA Seeks Funding for Pandemics, Cancer Drugs, and Generic Drug Approvals

Among the FDA’s total budget of $8.4 billion it is requesting for fiscal year 2023 are initiatives to improve pandemic preparedness, fight the opioid crisis, and approve generic drugs more quickly.

As part of President Joseph Biden’s fiscal year 2023 budget, the FDA is asking for nearly a 34% ($2.1 billion) increase over the agency’s fiscal year 2022 funding level, the agency said in a news release.

Robert M. Califf, M.D.

“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities,” said FDA Commissioner Robert M. Califf, M.D.

The agency is seeking $1.6 billion over five years to support the FDA’s contributions to the HHS Pandemic Preparedness Plan. The budget increase would allow the FDA to modernize its regulatory capacity by strengthening its information technology and laboratory infrastructure.

In addition, the FDA will focus on evaluation of vaccines and therapeutics to respond to any future pandemic or high consequence biological threat, facilitation of rapid development of diagnostics and work to support efforts to expand the personal protective equipment supply chain, the agency said.

The agency aims to amend the Hatch-Waxman 180-day patent challenge exclusivity provisions to “ensure that the exclusivity only lasts 180 days, as intended, rather than multiple years,” the agency said.

“This would substantially increase the likelihood that generic versions of patent-protected drugs come into the market in a timely fashion and would allow multiple versions of generic products to be approved quickly leading to significant cost savings,” the FDA added.

The agency is requesting $30 million in additional funds to advance the goal of ending the opioid crisis. “Funding will address four priority areas of the epidemic including decreasing exposure and preventing new addiction, supporting the treatment of those with opioid use disorder, fostering the development of novel pain treatment therapies and improving enforcement and assessing benefit-risk,” the FDA said.

The agency is asking for $20 million for the FDA’s efforts as part of Cancer Moonshot to speed progress in cancer research and improve cancer outcomes.

“The budget request provides a one-time infusion of funding to advance a variety of research, external collaborations and educational outreach programs and continue to support development and regulation of oncology medical products through the Oncology Center of Excellence,” the agency said.

The agency also wants to enhance drug and biologic accelerated approval provisions to “help ensure that the confirmatory studies will progress in a timely manner and reap high-quality, interpretable results,” the FDA said. "This will help minimize the time that a product is marketed before its clinical benefit can be confirmed.”

The agency also aims to require the destruction of imported products by their owner or consignee that have been refused and “pose a significant risk to public health.”

“The FDA believes this new authority would prevent the potential re-importation of these products and would deter owners and consignees from importing products they know to pose a significant public health risk. This authority could also increase efficiencies when Customs and Border Protection seizes an FDA-regulated product,” the FDA said.