Medical Gas Legislative Update

Medical gases, principally Oxygen USP, have been used for decades before the FDA was created in 1938. Since these gases were marketed before 1938, we were not required to submit a New Drug Application (NDA) in order to produce the drugs. This, in essence, was a “grandfathering” of these gases as drugs. However, the FDA never formally authorized the grandfathering concept.

The FDA informally allowed medical gases to be produced and even registered thousands of firms as medical gas manufacturers. Guidance documents and inspections proceeded for decades as if medical gases were “approved,” though they never were actually approved.

This was a stable, though informal, situation for 78 years. Then in June 2006, the FDA announced the “Unapproved Drug Initiative” designed to remove unapproved drugs from the marketplace. This initiative was clearly not aimed at medical gases, though there were some unintended consequences which affect our industry. The agency began requiring a declaration stating the medical gas was unapproved when U.S. companies attempted to export the product to other countries. This “Unapproved” drug status declaration only served to confuse international customers.

Inappropriate Regulations for Medical Gases
A parallel issue is the status of federal regulations for medical gas manufacturers. Some of the FDA’s Current Good Manufacturing Practices (CGMP, 21 CFR 210 & 211) simply cannot be applied to medical gases. In fact, about 85 percent of the CGMP sections would need minor/major revision to apply to the unique properties of medical gases. These properties include high pressures, low temperatures, dedicated distribution systems, reusable containers, reusable labels, etc.

Some of the inappropriate regulations include the requirement to calculate theoretical yields, expiration dates/stability studies, etc. To manage these inappropriate regulations, the agency uses “enforcement discretion.” One problem with federal “enforcement discretion” is that it may be applied inconsistently, especially among state inspections, which are required to enforce the actual rules and are prohibited from enforcing “discretion” on the state level.

In 1979, the FDA released the “Compressed Medical Gas Guidelines” in an effort to explain how to apply the regulations to medical gases. Even then, the FDA recognized that eventually, separate regulations would be appropriate for medical gases.

Nearly 33 years later, the situation is essentially the same. To the agency’s credit, they did attempt to modernize the 1979 guidance in 2003. However, the 2003 Draft Guidance was never finalized.

Progress Forward
Under Michael Tiller’s leadership at CGA and with GAWDA’s support, the medical gas industry began considering how to improve the situation for medical gas companies. After significant industry effort, Representatives Leonard Lance of New Jersey and Chris Murphy of Connecticut introduced H.R. 2227, The Medical Gas Safety Act. H.R. 2227 directs the FDA to create a path to recognize medical gases as approved drugs. The bill also requires FDA to work with industry to review the regulations relative to the unique characteristics of medical gases.

In March 2012, CGA and FDA both testified in front of the U.S. House of Representatives’ Energy and Commerce Committee. Since the congressional hearing, the FDA has demonstrated active good-faith in working with CGA to strengthen the Medical Gas Safety Act. As of this writing, we believe that the new legislation will be incorporated into the “Prescription Drug User Fee Act.” In the current language of the bill, the medical gas industry will be on a path for appropriate regulations, and the core gases and mixtures thereof that are medically appropriate would be approved and those gases would be exempt from user fees.

At this time, it is impossible to predict the success of the bill. However, the CGA/GAWDA effort has highlighted the legitimate need for a medical gas approval process as well as the need for more clear and consistent enforcement for medical gases. We are hopeful that this effort will be successful and lead to a more stable and consistent regulatory process for medical gases.

Contact me if you would like the latest update in our medical gas legislative efforts or for links to H.R. 2227 and congressional testimony about medical gases.

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.