FDA’s FY22 budget priorities: boost inspections, surveillance; avert device shortages

Regulatory NewsRegulatory News | 08 June 2021 |  By 

The US Food and Drug Administration’s FY 2022 budget request to Congress indicates the agency’s wishes to catch up on the backlog of inspections that have been delayed due to COVID-19, improve its drug surveillance efforts to detect possible shortages, and avert shortages for such medical devices as personal protective equipment (PPE).
Many of these requests have been driven by the need to combat device and drug shortages wrought by the pandemic.
The request also seeks additional authority to lengthen expiration dates for drugs that are in shortage and to expand the scope of its enforcement authority against counterfeit medical devices. It also requests new legislative authority for the FDA to request records in advance of or in lieu of inspections for device food and tobacco products;  this authority is already in effect for drugs.  
The request seeks $6.5 billion in funding for FY 2022 under President Joe Biden’s $6 trillion budget proposal announced on 28 May, an overall increase of $477 million (8%) over the agency’s FY 2021 budget (RELATED: Biden’s first budget request seeks $6.5 billion for FDA, Regulatory Focus 1 June 2021)
The “cross-cutting” budget request “reflects investments to advance FDA’s budget priorities,” including efforts to “advance food safety and medical product safety efforts” and address “critical infrastructure, buildings and facility needs,” according to the executive summary introducing the budget request.
Hiring More Inspectors
The FY 2022 requests calls for the hiring of 65 full-time employees and a budget increase of $18.8 million to enable  the Office of Regulatory Affairs (ORA) to catch up on its pandemic-induced backlog of inspections.
“Without additional resources, there is a risk of needing to lessen frequency of inspections at domestic and foreign manufacturers that supply their products to US consumers,” noted the agency in the justification for the boost in ORA’s budget. “Further, the proposed increase will support FDA’s ability to keep pace with the continued growth in the medical product industry and increase our responsiveness to foodborne outbreaks.”
New resilience program to prevent drug shortages
The budget also requests $21.6 million for the creation of a new resilience supply chain and shortages program (RSCSP) to monitor the medical device supply chain for potential shortages and allow the agency respond to early signs of supply constraints. The new office would be staffed with 18 full time employees.
The budget states that “The COVID-19 pandemic demonstrated that by the time there is an emergency, it is often too late to prevent shortages,” according to the budget justification. “Supply chain disruptions were already beginning to occur even before COVID-19 cases were identified in the U.S., as other nations had outbreaks and needed personal protective equipment (PPE), testing supplies, and other equipment in excess of supply.”
The program would require that manufacturers notify FDA if there is the potential for a device shortage. It would also require manufacturers to perform risk assessments, implement risk management plans, and identify alternate suppliers and manufacturing sites to prevent such shortages.
New surveillance tools
FDA also wants $5.6 million for drug safety surveillance and oversight for the hiring of 18 full time staff to improve and modernize its post-market surveillance programs.
In addition, FDA seeks the following new authorities from Congress:
Lengthier expiration dates
For drugs that are in shortage, FDA wants applicants to evaluate, submit studies for, and label the product with the longest possible scientifically justified expiration date.
“Shortages of drugs that are life supporting, life sustaining, or intended for use in the prevention of treatment of a debilitating disease or condition, can be exacerbated when drugs must be discarded because they exceed a labeled shelf-life due to unnecessarily short expiration dates,” noted the agency in the budget proposal.
Expansion of records requests
FDA also wants new legislative authority to request records in advance of or in lieu of inspections for device, food and tobacco products. FDA already this authority for drug inspections under section 704(a)(4) of the FD&C Act.
This expanded authority, wrote the agency, would help FDA “continue to protect the public health, including during a public health emergency like the COVID-19 pandemic, and help ensure the availability of emerging and medically necessary products” when in-person inspections are “inadvisable.”
The authority would also help optimize agency resources by determining if a facility is still in business, allowing the agency to avoid unnecessary travel; and improve efficiency of inspections by identifying in advance specific products or manufacturing processes before the actual on-site inspection.
Expanding definition of counterfeit device

FDA also wants broader enforcement authority against counterfeit medical devices. The current law, the Safeguarding Therapeutics Act, allows “only limited enforcement provisions," allowing destruction of medical devices refused import entry and valued at $2,500 or less. FDA proposes the provisions for counterfeit drug penalties and seizures contained in sections 301, 303 and 304 of the Food, Drug & Cosmetics Act and Title 18 of the US Code be expanded to apply to medical devices as well.
The budget proposal points out that FDA’s current enforcement powers are an ineffective deterrent against counterfeiting, as has been seen during the pandemic with a proliferation of counterfeit test kits, masks and respirators. The revision will “help keep counterfeit devices like these out of the United States and facilitate enforcement actions against those that find their way into interstate commerce,” according to the request.


© 2023 Regulatory Affairs Professionals Society.

Tags: budget, FDA

Discover more of what matters to you