The overall request includes $147.7m in budget authority for initiatives tied to several key areas, including the regulation of next generation sequencing services, and the management of drug shortages and inspections. Funding for the agency’s work with drugs and biologics would remain largely flat when compared with FY2015.
In terms of inspections, the agency said it has met or exceeded its inspection targets for high-risk facilities worldwide, though the definition of high-risk continues to change over time.
“High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment,” the agency said in its budget report. “Inspection priorities may be based on a firm’s compliance history or sample results. FDA has made inspecting high-risk domestic and foreign firms a priority, and has set multiple performance goals for these high-risk facilities. As a result of these efforts, in FY 2014 FDA met or exceeded inspection targets for human drugs facilities.”
The agency is also proposing a new user fee for international courier services that will amount to $500,000 total for the year. “Current FDA staffing does not match the expected growth in import volume. Federal Express and other couriers have indicated that they expect a growth of over 60 percent in shipments during the next year, further taxing FDA resources,” the agency said.
To address the growing volume of imports entering through international couriers, FDA is proposing to pay the cost of these import operations through the new user fee. The fee will help the agency conduct entry reviews, sample collections and physical exams to determine product admissibility into the US, and establish import controls to prevent future unsafe products from entering U.S. commerce.
“While it falls short of the money needed to meet FDA’s new and expanding responsibilities, the President’s request would double the increase in base funding over the prior four years,” the Alliance for a Stronger FDA said in a statement.
Jeff Allen, President of the Alliance and Executive Director of Friends of Cancer Research, added: "We urge the House and Senate appropriations committees to recognize the same FDA needs that the President has…The additional funding for food safety, precision medicine, drug compounding oversight, and antibiotics development will make a huge difference at the agency.”
Part of the funding increase will come for President Obama’s Precision Medicine initiative, unveiled Friday, which will also increase funding for NIH (National Institutes of Health) and the NCI (National Cancer Initiative).
FDA commissioner Margaret Hamburg said in a blog post that the additional funding will also go to “combating the growing threat of antibiotic resistance – in which drugs become less effective, or ineffective, against harmful bacteria; promoting the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to ‘personalize’ the diagnosis, treatment, and prevention of disease; implementing key FDASIA requirements to improve medical product review and inspections; [and] addressing the safety of compounded drugs.”
More than 54% of the agency’s FY2016 budget would be devoted to medical product safety, while 31% would go to food safety. The push for food safety, however, comes as President Obama is looking to take food safety out from under the FDA and create a new Food Safety Administration. Industry remains skeptical that such plans will take root.