Bipartisan Measure Would Help Streamline FDA Approval for Medical Gases
WASHINGTON – Congressmen Leonard Lance (R-NJ) and Chris Murphy (D-CT) have introduced bipartisan legislation that would help streamline the federal regulatory process for medical gases.
Specifically, the lawmakers introduced the Medical Gas Safety Act, H.R. 2227, which 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-Murphy 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 lawmakers said the legislation 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, a member of the House Energy and Commerce Health Subcommittee, said he first learned of the need to streamline medical gas regulations during a meeting with officials at Linde North America in Murray Hill, NJ. 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. “This common sense legislation will ensure medical gases can be delivered to the patients who need them.”
“For too long, the medical gas industry has been living under uncertain rules – putting American jobs on the line. This bill provides a sensible framework moving forward for the industry and the patients they serve,” said Congressman Chris Murphy.
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.”
According to the Compressed Gas Association, medical gas filing stations provide thousands of jobs across the country.
The lawmakers noted that 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 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.
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