The US Food and Drug Administration (FDA) has spent the eight years since a meningitis outbreak originating at New England Compounding Center killed at least 64 people trying to raise standards in the industry.
However, the effort remains a work in progress. The President’s Budget for the Department of Health & Human Services in the 2021 fiscal year notes the ongoing problems in the industry, stating that the FDA “continues to find significant problems at many inspected outsourcing facilities.”
Faced with the persistence of the problem, President Donald Trump is proposing to give the FDA an extra $4.5m (€4.2m) to spend on addressing the quality of compounding pharmacies. The extra money will bring the FDA’s total outsourcing facilities budget up to $78m, enabling the agency to step up its activities in certain areas.
The document states, “The budget will enable FDA to evaluate the over 300 unique bulk drug substances nominated for inclusion on the list of substances approved for compounding by industry. With this funding increase, outsourcing facilities are better positioned to meet healthcare providers’ and patients’ needs for quality compounded drugs.”
Actions taken by the FDA last year illustrate the scale of the problem facing the agency. Last year, the FDA issued around 100 Form 483s and more than 10 warning letters to compounding pharmacies. Federal courts entered consent decrees against several compounding pharmacies.
The FDA’s page of regulatory actions involving compounding pharmacies reveals a sustained surge in the identification of noncompliance starting in 2013. Equipped with the extra funding, the FDA hopes to help the industry get to the point that noncompliance is a far rarer outcome of inspections.
At this stage, it is unclear if the FDA will get the extra money. The proposal to give the FDA an additional $4.5m to address the noncompliance of outsourcing facilities was presented in the 2021 President’s Budget. If the FDA is to receive the money, Congress will need to vote in favor of the proposal.
Based on President Trump’s previous budgets, there is reason to think Congress will provide at least the requested money to the FDA. In previous years, Congress has consistently agreed to larger budgets for scientific agencies than those put forward by President Trump.