Appropriators Continue Pressing US FDA To Conduct Surprise In-Person Inspections

Omnibus package also gives FDA expanded authority over nicotine products and creates President Biden’s Advanced Research Projects Agency for Health.

US lawmakers continue to increase funding for surprise and in-person facility inspections by the Food and Drug Administration, but warn the agency that the money should be used as intended.

The fiscal year 2022 omnibus appropriations package includes an additional $5m for the agency to conduct unannounced inspections. The allocation for the Center for Drug Evaluation and Research and related Office of Regulatory Affairs activities also includes a provision that no less than $8.5m will be used for “pilots to increase unannounced foreign inspections.”

House Appropriations Committee members also seemed irritated about the FDA’s lack of progress in increasing facility visits over the past year. In addition to directing the agency to hire more foreign-based inspectors to boost short-notice and unannounced facility inspections in India, they also implied in the report accompanying the bill that the money already allocated for that purpose was not being spent as directed.

“The agreement notes that the intent of funds provided in the fiscal year 2021 bill were to increase unannounced inspections and not to assess the value of unannounced inspections or compare them to pre-announced inspections,” the report states.

The FDA told the Pink Sheet that the launch of its foreign unannounced inspection pilot program has been scheduled to begin in February, but was postponed because of the spread of the Omicron coronavirus variant. The agency will continue to monitor foreign travel conditions and reassess plans as needed. In the meantime, mission-critical inspections will continue.

FDA officials in 2021 considered whether to continue giving advanced notice on domestic, as well as foreign inspections, once the COVID-19 pandemic ends.  (Also see "US FDA Mulls Advance Notice On Domestic Surveillance Inspections Post-COVID" - HBW Insight, 16 Mar, 2021.)

Because the pandemic paused global travel, the FDA instituted alternative tools in order to relieve its growing inspection backlog. Agency inspectors now can now use cameras, data and other information to avoid some in-person visits. In some cases, a physical inspection still was necessary, leading to application assessment delays.  (Also see "Forty-Eight US FDA Drug Application Decisions Delayed By Pandemic's Deferred Inspections" - Pink Sheet, 5 May, 2021.)

However, House members told the FDA in their initial FY2022 funding bill, released in 2021, that virtual inspections should not be conducted when an in-person visit is possible.  (Also see "US FDA’s In-Person Foreign Inspections Remain On House Appropriators’ Minds" - Pink Sheet, 7 Jul, 2021.)

The push for more in-person inspections is not universal on Capitol Hill. In the initial Senate FY2022 appropriations bill, also released in 2021, members said the agency should conduct remote inspections to ensure approvals are not unnecessarily delayed.  (Also see "FDA Would Get Less Funding, Different Inspection Priorities Under Senate Legislation Than House" - Pink Sheet, 5 Aug, 2021.)

The mixed messaging continued in February, when members of the House Energy and Commerce Committee questioned FDA officials about how alternative inspection tools can be used more effectively, such as for generic and biosimilar facilities.

Center for Biologics Evaluation and Research Director Peter Marks said that he has seen only mixed results with remote inspections so far, while CDER Director Patrizia Cavazzoni said the availability of alternative tools is determined by the facility compliance history.  (Also see "Remote Inspections: Stakeholders Seek Clarity As Some At US FDA Struggle With Process" - Pink Sheet, 22 Feb, 2022.)

FDA Given 3% Increase In Non-User Fee Dollars

The FY 2022 omnibus appropriations bill Congress passed on 14 March and President Biden signed the next day would give the FDA $6.1bn, including $3.3bn in budget authority, or non-user fee dollars. The overall total is an increase of $219.9m compared to the omnibus FY 2021 appropriations legislation. About $102.2m of the increase would be budget authority (see charts below.)

The Alliance for a Stronger FDA, which advocates for increased agency funding, said the increase in non-user fee funding was “much needed and will strengthen programs throughout the agency.”

The group said that while larger FY 2022 increases were proposed by the House and Senate last year, the current amount “reflects continued congressional support for a strong, well-funded FDA.”

The House gave the FDA $3.45bn in budget authority in its initial FY2022 funding bill, while the Senate allocated $3.4bn.  (Also see "House Appropriations Committee Embraces Clinical Trial Issues In FY 2022 US FDA Budget Bill" - Pink Sheet, 7 Jul, 2021.)

Research!America also was pleased with the FDA’s increase, saying in a statement that “the under-funded agency’s extraordinarily broad and profoundly important mission calls for additional resources.”

Lawmakers earmarked $29m of the increase for medical product safety, as well as $41.3m for related cross-cutting initiatives. Another $2.4m was allocated for infrastructure investments.

The FDA received $8m of the increase to continue its campaign against the opioid crisis and $3m for its predictive toxicology roadmap. Another $1m was allocated for the agency’s data modernization and enhanced technology initiative.

The committee set $1m of the increase for rare cancer therapeutics, $2.5m for the orphan product grants program and $1.5m for rare disease issues.

In addition, $10m for inspections was included in the cross-cutting initiatives increase, as well as $2.2m for the Office of Chief Counsel.

CDER would receive the largest increase over FY 2021 by far. The $118.9m in additional funds for the center accounts for more than 54% of the total increase for the FDA.

The Center for Food Safety and Applied Nutrition would receive the second largest portion of the increase, about 15.5%, or $34m. CBER and CDRH each would receive about 9% of the increase, or about $19.8m and $19.5m, respectively.

New Tobacco Authority, ARPA-H Funding

House leaders stripped additional funding for the COVID-19 pandemic from the bill at the last minute amid concerns about the budget offset, which likely will affect the FDA.

But the agency would receive additional authority over synthetic and other nicotine products, closing a loophole in its tobacco regulations.

The Advanced Research Projects Agency for Health (ARPA-H), also would be funded with $1bn that would remain available until 30 September 2024.

ARPA-H is intended to fund projects pursuing large unmet needs that do not garner private sector interest. The agency is modeled after the Defense Advanced Research Project Agency (DARPA), which helped develop the Global Positioning System and Internet.

The idea has support on Capitol Hill, but lawmakers disagree on where the agency should be located. Some want ARPA-H within the National Institutes of Health, but others argue it should be a stand-alone agency within the Health and Human Services Department to be most effective.

The appropriations bill does not set a location for ARPA-H, saying that the HHS Secretary can transfer the agency, funding and personnel within 30 days of enactment to any office within HHS, including NIH.

Questions also emerged about whether ARPA-H would complement or dampen private investment, although similar questions were asked when the National Center for Advancing Translational Sciences (NCATS) was created at NIH.  (Also see "ARPA-H: New Health Research Agency Faces Old Concerns About Disrupting Private Investment" - Pink Sheet, 8 Feb, 2022.)

This article was reported and originally published by Informa Pharma Intelligence's Pink Sheet newsletter.