FDA wants funding to strengthen supply chain
This is an excerpt from Medically Necessary, a healthcare supply chain newsletter. Subscribe here.
Requirement: The Food and Drug Administration is asking Congress for a budget of $ 6.5 billion, an 8% increase from the previous year.
The new budget request proposes initiatives to regulate the healthcare supply chain and alleviate drug and medical device shortages.
A crude measure of the increased focus on the supply chain: The 2022 budget request mentions the supply chain almost 120 times, up from just over 50 the previous year.
This proposal is essentially a wish list. It will be up to Congress to decide how much money the health agencies will receive. But the requests indicate that the federal government hopes to make supply chain resilience a priority going forward.
A new program: The FDA wants $ 21 million to create a resilient supply chain and a medical device-focused shortage program. This medical device program would be similar to the FDA Drug Shortage Program, officially established in 1999.
Before the pandemic, the agency did not have a formal program to monitor the medical device supply chain. However, in its budget request, the agency highlights how it began to monitor the device supply chain without a formal program.
FDA staff contacted more than 1,000 manufacturers in 12 different countries to identify the vulnerabilities. The agency also gave manufacturers and healthcare providers regulatory flexibility to expand supplies and approved more than 600 new devices in the event of an emergency.
The proposed 18-person office would identify shortages before they happen and step in to prevent them.
New powers: The FDA also used the budget request to ask Congress for new regulatory powers to oversee the supply chain.
The agency wants the authority to:
- Require device manufacturers to alert the agency to potential shortages, perform risk assessments, implement risk management plans, and identify other supplies or manufacturing sites.
- Ask for records from device makers before or instead of an inspection, like what the agency did with drugmakers during the pandemic.
- Import unapproved devices and allow the use of approved devices beyond their shelf life in the event of a shortage.
- Ask drugmakers for more information on discontinued products and manufacturing disruptions.
Catch up: The FDA is also seeking funding for 65 full-time employees to help catch up with inspections of drug, food and medical device facilities delayed by the pandemic.
According to the Government Accountability Office, the FDA has not been able to perform more than 1,000 of its inspections scheduled for fiscal 2020.
A recent FDA report noted that delayed inspections slowed approvals for 48 drug production facilities, but only six of those applications were deemed critical.
Even without additional funding, the FDA is already using document requests and video surveillance tools to overcome the backlog of inspections. The FDA is prioritizing inspections related to high priority products, the COVID-19 pandemic, or serious violations.
However, the FDA says it will struggle to ensure the safety of medical products if it does not recruit new inspectors.
Others: Many 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 National Strategic Reserve and the Biomedical Advanced Research and Development Authority.
The news: The FDA and the Centers for Disease Control and Prevention are now asking hospitals to stop using crisis strategies to retain protective gear.
The agencies say the supply of respirators approved by the 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 hard to find. The CDC has proposed several “crisis strategies” to help hospitals cope with shortages.
Strategies included using masks beyond the printed expiration date, reusing masks, and prioritizing masks for the most risky tasks.
Another strategy was to use respirators approved by regulators in foreign countries. The CDC expected these masks, such as the China-approved KN95s, to provide similar levels of protection. Now health officials are calling on hospitals to move away from these strategies.
To get by : Teresa Dail, supply chain manager at Vanderbilt University Medical Center, said her hospital system purchased non-NIOSH-approved masks as a backup but never had to use them. The hospital system had been reusing the masks for a few months, but stopped doing so in August.
Likewise, Intermountain Healthcare has never used masks not approved by NIOSH, according to a spokesperson. The health system kept the N95 masks by reusing them but returned to single-use masks for several months.
Bounce: By February, most hospitals were no longer experiencing “extreme shortages,” according to a report from the Department of Health and Social Services. But many still struggle to get enough masks.
Since the start of the pandemic, NIOSH has approved more than 875 models of emergency ventilators. The FDA and CDC argue that these approvals have helped stabilize supplies.
Kim Anders, group vice president for strategic supplier engagement with the Premier purchasing organization, said it appears the new approvals have helped meet demand for respirators.
“In fact, we started to see the market stabilize in this category,” she said.
Orders for N95 respirators are now approaching pre-pandemic levels, Anders said, but they remain high.