Commissioner Scott Gottlieb, M.D., has laid out why he thinks the FDA needs a double-digit budget bump. Gottlieb pointed to work the FDA is doing to streamline drug development and get breakthroughs to patients faster to justify the budget request.
President Trump’s 2019 budget request for the FDA calls for the agency to receive $5.8 billion. That is $663 million, or 13%, more than the agency has to work with during the current fiscal year. More than 70% of the extra funding will come from extra budget authority, with the rest being provided by a step up in industry user fees.
The proposed jump in the FDA’s budget comes at a time when Trump is reining in spending at other scientific agencies. If the FDA is to get the money, Gottlieb needs to persuade Congress of the spending plan's merits.
That effort began this week with a meeting of the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. During the meeting, Gottlieb pointed to investments in digital health, advanced manufacturing and generic drug review to partly justify the spending plan. But the commissioner made efforts to streamline the development of novel drugs the centerpiece of his pitch.
The anticipated efficiency stems from the FDA’s investment in a knowledge management system that will store the experience the agency gains each time it reviews a drug. This information will feed into multiple FDA activities, including disease-specific guidelines that show the most efficient way to develop drugs in particular indications.
Guidance on ulcerative colitis, rare pediatric cancers, pediatric HIV and life-threatening noncancer blood disorders are in the pipeline.
“These guidance documents will aim to apply modern principles to make drug development more efficient by focusing on the most effective ways to prove safety and efficacy,” Gottlieb said in prepared remarks. “For example, the guidance on blood disorders will allow drug developers to reduce the use of animal testing and will outline ways to measure benefit that may permit more efficient development programs and earlier approvals.”
Collectively, the guidance documents form part of an effort by the FDA to help companies develop drugs against rare, serious diseases that pose distinct challenges to R&D teams. Applying general research strategies and clinical trial designs to these indications can lead sponsors down the wrong path. The FDA wants that to stop happening—and is after an extra $663 million to support its effort.