Bipartisan Measure Would Help Streamline FDA Approval for Medical Gases

WASHINGTON– Congressman Leonard Lance (NJ-07) has introduced bipartisan legislation that would help streamline the federal regulatory process for medical gases.  Lance, a member of the House Energy and Commerce Health Subcommittee, jointly authored the "Medical Gas Safety Act" with Rep. Chris Murphy (D-CT).  

Specifically, the Medical Gas Safety Act, H.R. 2227, would create a new, targeted drug application process and regulatory regime specifically for medical gases.  A medical gas is defined as one that is manufactured, packaged, and intended for administration to a patient in anesthesia, therapy, or diagnosis.

The Lance bill would ensure that patients will not be deprived of their medical gases like oxygen, nitrous oxide, nitrogen or carbon dioxide based on the lack of clear federal guidelines.  

The Seventh District lawmaker said his bill was necessary because current federal regulations do not take into account the unique manufacturing and distribution characteristics of medical gases.  For example, medical gases cannot be transported more than one hundred miles from their filling stations to places like hospitals, medical offices and nursing homes.

Congressman Lance said he first learned of the need to streamline medical gas regulations during a meeting with officials at Linde North America in Murray Hill.  Lance regularly meets with Seventh District business leaders to discuss how federal laws and regulations impact jobs and economic development.

“One of the most important parts of my job is to ensure federal regulations are not hurting job growth and economic innovations,” said Lance.  “My common sense legislation will ensure medical gases can be delivered to the patients who need them.”

Pat Murphy, President of Linde North America said, “We praise Representatives Lance and Murphy for introducing legislation that will provide a long overdue solution that will improve patient safety, and reduce the regulatory burden in complying with drug regulations that are not designed with medical gases in mind.”

In New Jersey there are dozens of medical gas filling stations and according to FDA more than 3,000 manufacturing and transfilling locations across the country.  In the Seventh District, medical gases are distributed to places like Hunterdon Central Regional Medical Center in Flemington, Somerset Medical Center and J.F.K Hospital in Edison, pediatric and dental offices as well as senior living centers.

According to the Compressed Gas Association, medical gas filing stations provide hundreds of jobs in New Jersey and thousands of jobs across the country. 

Lance said the Medical Gas Safety Act will not only provide certainty to the marketplace and preserve jobs in the medical gas industry, it will also ensure the safety and continued availability of medical gases, like oxygen, to New Jersey residents and the millions of Americans nationwide who suffer from illnesses like Chronic Obstructive Pulmonary Disease (COPD). 

The National Heart, Lung and Blood Institute estimates that 12 million adults suffer from chronic pulmonary diseases and another 12 million are undiagnosed or developing them.   

###