If you are a follower of mine on Twitter, you may have noticed that there was a Congressional hearing about medical gas regulations on Thursday, March 8. Among the many issues discussed were the regulatory challenges facing medical gas manufacturers and distributors. The underlying problem is that medical gases like oxygen, nitrogen and carbon dioxide are currently subject to the same regulations as pharmaceutical drugs, despite entirely different manufacturing distribution processes. Many in the gas industry believe that FDA needs to develop regulations that are targeted at medical gases specifically.
The industry has made a lot of progress on this front recently, as evidenced by the proposed Medical Gas Safety Act (HR 2227), introduced by Rep. Lance and cosponsored by members from both sides of the political aisle. The Congressional hearing was another step forward, as the industry was given a forum to plead its case. The Compressed Gas Association was represented by LifeGas president Michael Walsh.
In watching the hearing, I was shocked to learn that gases like oxygen are considered “unapproved drugs” in some venues. The problem, as Walsh explained, is that many customers are scared off by the “unapproved” label, causing them to cancel orders. The Medical Gas Safety Act would help resolve this by creating a process for medical gases to gain approval.
Another issue is expiration dates, which some government agencies attempt to enforce on medical gases. Walsh says, “Oxygen is an element of the periodic table. By its basic properties it will never expire.” Overall, Walsh was extremely well spoken. Let’s hope Congress and the FDA agree. You can read Walsh’s initial testimony here, or view the discussion in the video below.
From here, the next step for CGA is lobbying to have the Medical Gas Safety Act included with the Prescription Drug user Fee Act (PDUFA). At this point, there is a chance that FDA could attempt to block this effort, but there is hope. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, also testified at the hearing. Dr. Woodcock said the FDA would be willing to work with CGA and industry manufacturers to come to a mutually beneficial solution. We’ll see what happens from here.
What do you think: Should the FDA adopt separate regulations for medical gases? How is your business affected by the current lack of specific medical gas regulations?
If you missed the Twitter chat yesterday, you can catch up by checking out hash tag #medicalgas.
View the Congressional hearing below or watch it on YouTube. It’s kind of a long one, but worth watching the discussions about medical gas.