President Biden’s budget proposal would increase the Food and Drug Administration’s budget by nearly 34 percent compared with the current fiscal year, with much of the $2.1 billion increase aimed at preparing for another pandemic.
The agency also proposes to tackle a wide range of priorities, such as shoring up the accelerated approval program for certain drugs, registering dietary supplements, forcing importers to destroy rejected goods and requiring baby-food makers to test for heavy metals.
The agency said $1.6 billion of the increase would go to support the Health and Human Services Department’s pandemic preparedness plan. Those funds would help the F.D.A. evaluate vaccines and bolster the rapid development of tests and the supply chain for personal protective gear.
The F.D.A.’s total budget would soar to $8.4 billion under the budget plan. Some parts of the proposal aim to strengthen the agency’s oversight, including in the accelerated approval program, which fast-tracks the marketing of drugs for serious conditions with no other therapy.
The program has been criticized for giving drugs the green light and allowing them to remain on the market — for over a decade in the case of one drug meant to prevent preterm birth — before their effect is proven or the drug is withdrawn. The proposal says it would speed up the follow-up study process, ensure high-quality results and make technical changes to enable the agency to withdraw drugs that do not show a benefit.
The budget proposal also says the agency would begin to register the 50,000 to 80,000 dietary supplements on the market. It would also clarify the agency’s authority to make it easier for the agency to enforce laws against unlawfully marketed supplements. In recent years, the agency has sent out dozens of warnings, for example, about supplements with names like Kangaroo Intense Alpha and Willy Go Wild that contain undeclared quantities of erectile dysfunction drugs.
The F.D.A. is also seeking the authority to force importers to destroy products that are rejected at U.S. borders that pose a significant public health risk.
The budget plan would also address advocacy groups’ findings about toxic metals in baby foods, requiring companies to test the products and share the results with the F.D.A. Other items would aim to end the opioid crisis, enhance cybersecurity in medical devices and force cooperation with remote facility inspections.
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