This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.

The request: The Food and Drug Administration is asking Congress for a $6.5 billion budget, an 8% increase over the previous year.

The new budget request proposes initiatives to regulate the health care supply chain and mitigate shortages of drugs and medical devices.

One crude measure of the increased focus on supply chain: The 2022 budget request mentions supply chain nearly 120 times, compared to just over 50 the previous year.    

This proposal is essentially a wish list. It will be up to Congress to decide how much money health agencies get. But the requests indicate the federal government hopes to make supply chain resiliency a priority going forward.

A new program: FDA wants $21 million to create a Resilient Supply Chain and Shortages Program focused on medical devices. This medical devices program would be similar to the FDA’s Drug Shortages Program, formally created in 1999.

Before the pandemic, the agency didn’t have a formal program to monitor the supply chain for medical devices. However, in its budget request, the agency highlights how it began monitoring the supply chain for devices without a formal program.

FDA staff reached out to more than 1,000 manufacturers in 12 different countries to identify vulnerabilities. The agency also gave manufacturers and health care providers regulatory flexibility to stretch supplies and approved more than 600 new devices on an emergency basis.

The proposed 18-person office would identify shortages before they happen and intervene to prevent them.

New powers: FDA also used the budget request as a way to ask Congress for new regulatory powers to oversee the supply chain.

The agency wants authority to: 

Require device manufacturers to alert the agency about potential shortages, perform risk assessments, implement risk management plans and identify alternate supplies or manufacturing sites. 

Request records from device manufacturers ahead of or in lieu of an inspection, similar to what the agency did with drug manufacturers during the pandemic. 

Import unapproved devices and allow approved devices to be used beyond their shelf life during shortages.

Request more information from drug manufacturers about discontinued products and manufacturing interruptions. 

Catching up: FDA is also requesting funding for 65 full-time employees to help catch up on inspections of drug, food and medical device facilities delayed by the pandemic.

According to the Government Accountability Office, the FDA wasn’t able to complete more than 1,000 of its planned inspections for fiscal year 2020. 

A recent FDA report noted delayed inspections slowed down approvals for 48 drug production facilities, but only six of those applications were deemed critically important.

Even without extra funding, FDA is already using document requests and video-monitoring tools to work through the backlog of inspections. FDA is prioritizing inspections related to high-priority products, the COVID-19 pandemic or serious violations.

However, the FDA claims it will have a hard time guaranteeing the safety of medical products if it doesn’t get new inspectors. 

The others: Several other federal health agencies are also asking for funding to tackle supply chain issues. The Department of Health and Human Services is asking for substantial budget increases for the Strategic National Stockpile and the Biomedical Advanced Research and Development Authority.  

FDA tells hospitals to stop using unapproved masks

(Photo: CDC/Debora Cartagena)

The news: The FDA and Centers for Disease Control and Prevention are now telling hospitals to stop using crisis strategies to conserve protective equipment.

The agencies say the supply of respirators approved by CDC’s National Institute for Occupational Safety and Health, such as N95 masks, is now much more stable.

Background: In the spring of 2020, NIOSH N95 masks were difficult to find. The CDC offered several “crisis strategies” to help hospitals cope with shortages.

The strategies included using masks past the printed expiration date, reusing masks and prioritizing masks for the highest-risk jobs. 

Another strategy was using respirators approved by regulators in foriegn countries. The CDC expected those masks, such as KN95s approved by China, to provide similar amounts of protection.  Now, health officials are asking hospitals to transition away from those strategies.  

Getting by: Teresa Dail, chief supply chain officer at Vanderbilt University Medical Center, said her hospital system purchased some non-NIOSH-approved masks as a backup but never had to use them. The hospital system was reusing masks for a few months, but stopped doing that in August.

Similarly, Intermountain Healthcare never used non-NIOSH-approved masks, according to a spokesperson. The health system did conserve N95 masks by reusing them but has been back to single-use masks for several months. 

Bouncing back: By February, most hospitals were no longer experiencing “extreme shortages,” according to a report from the Department of Health and Human Services. But many still struggled to get enough masks. 

Since the start of the pandemic, NIOSH has approved more than 875 respirator models on an emergency basis. FDA and CDC argue those approvals have helped stabilize supplies.

Kim Anders, group vice president for strategic supplier engagement with the purchasing organization Premier, said it appears that the new approvals did help meet the demand for respirators. 

“We’ve actually started to see the market stabilize in that category,” she said.

Orders for N95 respirators are now approaching pre-pandemic levels, Anders said, but they remain elevated.