FDA Issues Final Rule Overhauling Regulation of Medical Gases
On June 18, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule that governs current good manufacturing practices (CMPGs), certification, postmarketing safety reporting, and labeling requirements for certain medical gases. These regulations are aimed at fulfilling a longstanding request from the medical gas industry that FDA tailor these requirements to better fit the unique nature of medical gases. More than once, Congress nudged FDA to undertake this rulemaking.
The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 included several important provisions related to medical gases. FDASIA defined the term “designated medical gas” to include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, medical air (all meeting the standards set forth in an official compendium), and any other medical gas deemed appropriate by the Secretary of Health and Human Services (and by delegation, FDA). FDASIA then established a streamlined certification process that takes the place of the normal new drug approval pathways (i.e., submission of a new drug application or an abbreviated new drug application) for designated medical gases. A designated medical gas with a certification granted is deemed to have in effect an approved application under section 505 of the Food, Drug, and Cosmetic Act (FD&C Act) (new drugs for human use) or section 512 (new drugs for animal use). Medical gases other than designated medical gases remain subject to regular drug approval under section 505 or 512.
FDASIA also directed FDA to determine whether any changes to federal drug regulations were needed with respect to medical gases and report to Congress on that determination. FDA’s 2015 report to Congress on this subject stated that “although some regulation changes are necessary to implement the medical gas labeling provisions contained in FDASIA, the current regulatory framework is adequate and sufficiently flexible to appropriately regulate medical gases” and said it would continue to evaluate the need for regulatory changes on an ongoing basis.
After FDA declined to undertake rulemaking in response to FDASIA, the Consolidated Appropriations Act of 2017 (signed into law on May 5, 2017) more directly required FDA to undertake rulemaking to revise federal drug regulations with respect to medical gases. That law required FDA to issue final regulations no later than July 15, 2017, giving FDA just over two months to develop and publish a proposed rule, review public comments, and publish the final rule. FDA did not meet that deadline, but it did develop the proposed and final rules in a relatively short timeframe compared to the pace of federal rulemaking generally, and at a time when its resources were diverted by the COVID-19 public health emergency.
The final rule issued this week is intended to take into account the unique nature of medical gases in four major areas: labeling, CGMPs, certification and postmarketing quality, and safety reporting. With respect to labeling, for example, the declaration of net quantity of contents may be stated in terms of volume measure for designated medical gases. Certain warning statements are required for oxygen containers including, for example, a statement and graphic symbol warning against smoking, vaping, or having open flames near oxygen. The final rule includes a new 21 CFR part 213 setting forth CGMP requirements for medical gases. Provisions regarding stability testing and expiration labeling apply to medical gases marketed under applications submitted under section 505 or section 512 of the FD&C Act and not to designated medical gases. Regarding postmarketing safety reporting, Individual Case Safety Reports need not be submitted when a patient who was administered oxygen dies unless there is evidence to suggest that the death was caused by administration of the oxygen. This exception is based on recognition that oxygen is commonly administered during end-of-life care and is unrelated to patients’ deaths.
The medical gas industry may not have gotten all the relief it sought (do a word search in the preamble to the final rule for “FDA disagrees”), but these and other technical revisions to FDA’s drug regulations bring about sensible reform aimed at making FDA’s drug regulations work better when applied to medical gases.