In 2022, industry fees accounted for almost 86 per cent of the regulator’s €417 million in revenues its latest accounts show. Investigate Europe can reveal how just 21 companies provided half of these fees received for drug authorisations.
In FY 2022, human drug user fees funded about 66% of the human drugs program budget, which is approximately $1.4 billion, making it a significant source of revenue for the FDA. While user fees vary significantly by program, the pharmaceutical industry's contributions are substantial, with other sources reporting that user fees account for roughly 45% of the entire FDA's budget and that the industry provides around 75% of the funding for the drug review process.