The Medical Gas Safety Act

Medical OxygenMedical oxygen has been used since before Congress created the Food and Drug Administration (FDA) in 1938. In June 2006, the FDA began the “Unapproved Drug Initiative” with unintended consequences for medical gases. The result was that oxygen and other medical gases began to be treated as “unapproved” drugs.

Besides the unapproved drug issue, the FDA’s Current Good Manufacturing Practices (CGMP) regulations were designed for “Big Pharma” and do not address the unique nature of medical gases (reusable containers, pressurized or cryogenic product, closed distribution systems, etc.).

The FDA has attempted to manage medical gas compliance with “guidance” which has been unevenly enforced. Indeed, the FDA uses “enforcement discretion” to simply ignore certain regulatory requirements (expiration dates, etc.). However, state Boards of Pharmacy sometimes do not recognize the enforcement discretion and act counter to the FDA’s leadership.

For years, GAWDA and CGA engaged the FDA directly on each regulatory issue. Several years ago, we began preparations to seek relief directly from Congress. In 2010, Representative Leonard Lance (R-NJ) introduced H. R. 2227, the Medical Gas Safety Act. After significant work from CGA President Mike Tiller, the proposed bill received bipartisan support in both the House and Senate. The bill eventually was incorporated into the ‘‘Food and Drug Administration Safety and Innovation Act,” S. 3187, and was passed by both houses of Congress. The President signed the bill into law on July 10, 2012.

Food and Drug Administration Safety and Innovation Act
Passage of the Food and Drug Administration Safety and Innovation Act accomplishes the following major goals for our industry:

  1. Establishes “Designated Medical Gases” with the protection of “approved drug” status for the common pure medical gases and mixtures.
  2. Provides for intellectual property protection if a company develops a new medical gas.
  3. Establishes a certification process for the designated medical gases to be produced.
  4. Requires the FDA to consult with the medical gas industry about the need for medical gas regulations. Provides a framework to develop/revise medical gas regulations.
  5. Assures Drug User Fees are NOT applied to medical gases.

The elimination of drug fees for medical gas manufacturers is a major victory for our industry. For example, drug user fees for traditional drug companies currently range from $98,970 to $1,841,500, depending on the activity. By act of Congress, medical gases are exempt from these fees.

The following gases are defined as Designated Medical Gases: oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, medical air and mixtures of these gases.

The surprise in the designated mixture list is carbon monoxide. The FDA insisted on including carbon monoxide in the list since it is used as a key ingredient in Lung Diffusion Test Mixtures. This is an interesting requirement since Lung Diffusion Test Mixtures are currently regulated as devices, not prescription drugs. There are other ingredients in some of these mixtures that are not included in the designated gas list (methane, neon, etc.). We will seek clarification from the FDA about carbon monoxide during the industry consultation phase of the bill.

In addition to the carbon monoxide issue, we will be consulting with the FDA about how the registration/certification process will work for medical gases. The language in the Act does not clarify what, if any, changes will be made to the registration process. As this issue is resolved, we will advise GAWDA members.

Please contact me if you would like the full text of the act or would like further information.

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.