Medical Gas Act Gains Momentum

The House Energy and Commerce Subcommittee on Health met on March 8, 2012, to consider legislation that would create a separate approval process and a targeted set of regulations at the FDA for medical gases. LifeGas president Michael Walsh testified on behalf of the Compressed Gas Association about the Medical Gas Safety Act, stating that this legislation would eliminate regulatory uncertainty, promote safety and ensure a continued supply of critical medical gases for patients. Walsh urged the Committee to include the Medical Gas Safety Act in a broader piece of legislation that would reauthorize FDA drug approval programs.

Legislation was introduced in Congress last year by Representatives Leonard Lance (R-NJ) and Chris Murphy (D-CT) to create a streamlined approval process for medical gases that have been used safely for decades. It would also require a targeted set of FDA standards for labeling, distribution and good manufacturing practices for medical gases. Current FDA regulations are a poor fit for medical gases and create confusion and uncertainty. The bill, the Medical Gas Safety Act (HR 2227), is under consideration by the Committee.

Walsh told Subcommittee members that medical gases are used by more than one million patients every day, and that the most common medical gas, oxygen, has been used safely for more than a century. “Medical gases, many of which are derived from the air we breathe, have a long history of safe and effective use. But medical gases need a separate regulatory system that takes into account their unique characteristics. This legislation will create regulatory certainty for our industry and ensure that patients and the medical community have access to these life saving products.”

Since the hearing, two additional Congressmen have signed on as co-sponsors of the Medical Gas Safety Act, bringing the total number of co-sponsors to nine. The new co-sponsors, Representatives Gingrey (R-GA) and Guthrie (R-KY), are both members of the Energy and Commerce Health Subcommittee. The Compressed Gas Association’s Medical Gas and Regulatory Policy Committee, of which GAWDA is a member, continues to meet with lobbyists and congressional staff about medical gas regulations.

The Congressional hearing can be viewed in its entirety in the video below. A timeline of the key speakers is available below the video.

Pitts Intro 00:01:08 00:01:48 00:40
Pallone Intro 00:05:11 00:06:07 00:56
Pallone and Woodcock Q&A of Woodcock 00:32:01 00:35:07 03:06
Lance and Woodcock Q&A of Woodcock 01:17:32 01:20:49 03:17
Cassidy and Woodcock Q&A of Woodcock 01:27:10 01:27:27 00:17
Walsh Testimony 01:51:09 01:57:28 06:19
Pitts and Walsh Q&A of Walsh 02:02:09 02:03:13 01:04
Lance and Walsh Q&A of Walsh 02:20:51 02:25:22 04:31
Pallone and Walsh Q&A of Walsh 02:32:03 02:33:27 01:24

Click on the start times above to launch the video at the specified time. Each video will open in a new window.

Gases and Welding Distributors Association