This week, Scott Gottlieb, MD, Commissioner of the FDA, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.
This week, FDA Commissioner Scott Gottlieb, MD, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.
The President’s budget request for 2019 proposes $5.8 billion in total resources for the FDA—an increase of $633 million—which is 13% more than the provided in the 2018 Annualized Continuing Resolution.
Gottlieb said that, using these funds, the FDA would undertake a number of initiatives, including a program to modernize the review of generic drug applications as a way to increase competition, address high drug costs, and advance new approaches to support development of treatments for rare diseases.
One particular initiative got a special mention from Gottlieb: building a knowledge management platform for drug and medical device review programs to help make the review program more efficient, rigorous, transparent, and consistent.
The platform, he said, would “enable us to store and manage the collected experience of our medical review staff—to have a way to identify how decisions are made across different functions, the scientific precedents we establish in the course of our review process, and the knowledge we develop.” Currently, FDA staff have limited options to query review decisions or extract information about how those decisions were made. “We can’t store and interrogate the scientific precedent we establish every day.”
Increased funding would also help the agency to develop new guidance documents for developing drugs to treat ulcerative colitis, pediatric cancers, pediatric HIV, and non-cancer blood disorders. Disease-specific guidance documents—of which the agency hopes to issue “hundreds”—Gottlieb said, should help drug developers to better navigate the path to drug approval.
The President’s budget, released in February 2018, includes other provisions of interest for healthcare stakeholders; the White House called for the creation of a National Institute for Research on Safety and Quality (replacing the Agency for Healthcare Research and Quality under HHS); the transfer of the National Institute of Disability, Independent Living, and Rehabilitation Research from HHS to the NIH; and the transfer of the National Institute of Occupational Safety from the NIH to the Centers for Disease Control. The plan would also provide the NIH with an additional $750 million for research on the opioid crisis ($400 million of which would be spent on public-private partnerships).