June 3, 2021 – The Food and Drug Administration (FDA) has asked Congress for a $6.5 billion budget, an 8% increase over the previous year.
Congress will ultimately decide how much money the various health agencies get, but the requests indicate the federal government hopes to make supply chain resiliency a priority going forward.
The new budget request proposes initiatives to regulate the healthcare supply chain and mitigate shortages of drugs and medical devices.
After last year, its easy to see that the focus on the supply chain has increased dramatically. According to FreightWaves, the 2022 budget request mentions supply chain nearly 120 times, compared to just over 50 the previous year.
Among other things, the FDA wants $21 million to create a Resilient Supply Chain and Shortages Program focused on medical devices. The program would be similar to the FDA’s Drug Shortages Program, created in 1999.
Prior to the pandemic, the agency didn’t have a formal program to monitor the supply chain for medical devices. In the budget request, the FDA highlights how it began monitoring the supply chain for devices without a formal program. The proposed 18-person office would identify shortages before they happen and intervene to prevent them.
The 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 it 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.
The 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. Even without extra funding, FDA is already using document requests and video-monitoring tools to work through the backlog of inspections. However, the FDA says it will have a hard time guaranteeing the safety of medical products if it doesn’t get new inspectors.