E&C Republican Leaders to EPA: Your Delay Will Create Shortages for Vital Medical Devices like Inhalers
Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Brett Guthrie (R-KY), and Environment, Manufacturing, & Critical Materials Subcommittee Chair Bill Johnson (R-OH) sent a letter to Environmental Protection Agency (EPA) Administrator Michael Regan today pressing the EPA to stop delaying regulations for reclaiming and reusing hydrofluorocarbons (HFCs), which are essential for ensuring Americans have access to affordable medical devices, like inhalers.
Excerpts and highlights below:
UNDERMINING CONGRESSIONAL SAFEGUARDS: “We are concerned... that Congress’s deliberate safeguards are being undermined by poor regulatory planning. While we acknowledge EPA has been prioritizing the implementation of AIM over the last two years, EPA appears to have de-prioritized plans to implement fully AIM’s reclaim and reuse provisions. For instance, the White House’s most recent Unified Regulatory Agenda contains plans for two EPA rules for AIM, but only mentions EPA plans to ‘consider’ a rulemaking on the limited reclaim and reuse of HFCs. A more committed approach is needed.
SHORTAGES OF VITAL MEDICAL DEVICES: “One specific example highlighting the serious, real-world impact of delaying the implementation of AIM’s reclaim and reuse provisions relates to the potential lack of available or affordable meter dose inhalers (MDIs) for asthmatics. According to an EPA-requested, September 2021 market characterization analysis of the U.S. MDI industry, the current and projected amount of HFC propellant sold in MDIs in the U.S. was rising and projected to increase. The report further stated that six manufacturers, using HFC-134a as a propellant, supplied albuterol sulfate MDIs to the U.S. marketplace. Based on this report and historic manufacturer expectations, EPA awarded essential use allowances for 2023 to eight MDI manufacturers on October 1, 2022.
“A substantial percentage of the manufacturers identified to EPA are no longer making their product – creating market and affordability issues for patients and State Medicaid programs. We are worried that forcing albuterol MDI manufacturers to rely upon constrained and increasingly expensive options to satisfy the market’s needs jeopardizes the supply of essential public health devices and endangers drug access, availability, and affordability for Americans. Moreover, this is the very type of crisis Congress envisioned when it exempted reclaimed and recycled HFCs. EPA must open that pathway.
CLICK HERE to read the full letter.