Acting FDA Commissioner Janet Woodcock, MD, outlined the agency’s budget priorities for fiscal year 2022 during a Senate Appropriations subcommittee hearing on Thursday.
The FDA has requested $6.5 billion for its FY 2022 budget, which is $477 million or 8% more than the FY 2021 enacted program level budget, and a $343 million increase in its total budget authority, according to Woodcock’s written testimony.
During the hearing Woodcock fielded specific questions regarding how the agency’s new funding would address problems such as youth vaping, the opioid epidemic, and how to increase diversity in clinical trials.
Funding will be directed toward three core priorities with the following allotments, Woodcock explained:
- $185 million for critical public health infrastructure
- $97 million for medical and food safety programs
- $61 million to address pressing public health concerns
Of the $185 million directed toward critical public health infrastructure, $76 million will be used to support data modernization efforts, she said.
One byproduct of the rapid technological advances and scientific breakthroughs of the last several years has been the increased volume and variety of data, she noted.
Currently, the agency is “hampered by antiquated methods” of managing this flood of information, but new funding would allow the agency to collect data more efficiently, identify and respond to problems more quickly, and improve its review times for medical products.
Of the $97 million for medical and food safety programs, the agency is specifically asking for an additional $22 million to develop a “resilient supply chain and shortages program” (in response to the medical device shortages experienced during the pandemic); another $18 million to review “increasingly complex infant formula submissions”; and an increase of $45 million for the agency’s “smarter food safety blueprint” to help prevent foodborne illnesses and ensure equitable health outcomes.
The $61 million to address public health concerns would include $38 million to support the development of opioid overdose reversal treatments, digital health medical devices and treatments for opioid use disorder, and satellite labs at international mail sites (to prevent opioids from being sent through the mail), as well as improved guidance for clinicians. The agency has also earmarked $19 million for modernizing “inspectional activities” — to keep staff on board who were hired with supplemental funding and to expand foreign inspection teams — and $4.7 million to improve health equity and address health disparities.
Lastly, the agency has proposed an additional $100 million in user fees to improve both product review and enforcement activities, in particular to target youth tobacco use. Woodcock explained that the agency is legally required to identify “a net benefit to the public health” for e-cigarettes. For example, the benefit of helping adults to stop smoking must outweigh the potential harms, such as “attractiveness to youth.”
Currently these products do not pay user fees and the agency has had to divert large numbers of staff to review 6.1 million products, which in turn limits its enforcement efforts, Woodcock noted.
And while a recent survey found youth use of tobacco has fallen, Woodcock stressed that there are still over 4 million underage people using tobacco products.
“So we really need to keep the pressure on, and that’s why we’re asking for an additional user fee,” she said.
Sen. Tammy Baldwin (D-Wisc.), chairwoman of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, noted that there isn’t an FDA-approved method for treating nicotine addiction in children and asked how the agency is addressing the problem.
Woodcock said that a number of workshops have been convened to focus on the issue and that Baldwin was correct in saying that the conventional smoking-cessation aids for adults don’t appear to work well in children.
“So, we need to pursue more research on this,” particularly because the “most committed smokers” begin smoking underage, Woodcock said. “We need to figure out a way to stop that as soon as possible.”
With regard to the funding for the opioid epidemic, she explained that in addition to interdiction at mail facilities, monies would be directed to developing better pain medication and treatments for opioid use disorder that don’t require patients to go to a doctor’s office.
“It’s been very, very difficult to get new pain meds,” because each one seems to have some type of liability, she noted.
For instance, the non-steroidal anti-inflammatories can cause gastrointestinal bleeding and opioids have the potential for abuse.
On the issue of diversity in clinical trials, Baldwin asked Woodcock to further explain how this problem would be addressed.
Woodcock said that women now make up the majority of participants in clinical trials, but as for including minority populations, “much more needs to be done.”
The FDA’s Office of Minority Health and Health Equity will be partnering with certain institutions using grants and fellowship to help train people to go into the community and meet potential study participants by engaging the providers who typically care for them, and in the places where they usually receive care.
“We need to shift our mindset … from thinking, ‘Well, we just need to encourage these folks to enroll.’ No, we need to go to where they are,” Woodcock said.