FDA is asking for 8% more money this year, a total of $5.1 billion, for its FY 2017 budget. Efforts to improve medical device quality and safety will get more than $3.2 million of the requested budget, along with $38 million for user fees. The agency is looking to boost product device safety and availability via:
- Evaluating tools that enable personalized diagnosis and treatment of disease
- More inspection and enforcement, along with policy development, to improve the safety of compounded drugs
- Supporting animal drug and medical device review
Combination products will get a little bit of help via the National Cancer Moonshot Initiative, for which FDA is asking for more than $75 million in mandatory funding. The agency is creating a virtual Oncology Center of Excellence to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices”. According to an FDA press release, this center will accelerate the development of new combination products, along with supporting development of companion diagnostic tests and using combination products to treat cancer.
FDA also wants more than $3 million for building and facilities funding, and more than $600,000 to support other areas of boosting the agency’s infrastructure.