The mission of AAHomecare's Medical Gases Council is to: Facilitate discussion between the Home Medical Equipment (HME) industry and regulating agencies, accrediting bodies,…Read More
AAHomecare supports the Medical Gas Safety Act included in the Food and Drug Administration (FDA) user fee reauthorization bills that are currently working their way through the legislative process. The Medical Gas Safety Act would improve the regulation of medical gases by allowing the FDA to establish a set of rules outside the New Drug Application (NDA).
Under the NDA, medical gases are regulated similarly to medications available in a pharmacy. The FDA has acknowledged that the NDA should not apply to gases and, up to this point, has not enforced the regulation with providers or manufacturers.
Both the House and Senate versions of the FDA user fee reauthorization bill (H.R. 5651 and S. 3187) contain language that would create unique regulations for medical gases to better account for their use and safety. The language is similar to H.R. 2227, which was introduced late last year by Representatives Leonard Lance (R-N.J.) and Chris Murphy (D-Conn.).
The Association sent a letter to the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee leadership commending them for including the medical gases provision in their bills.
“[T]he unique manufacturing and distribution process for medical gases is distinct from any other class of drug products and does not fit well into the current Food and Drug Administration (FDA) regulatory process,” AAHomecare stated in the letter. “H.R. 2227 is bipartisan legislation … that will protect the public’s health by ensuring that patients will not be deprived of essential medical gases because of an approval process and regulatory regime that does not fit these products.”
The Senate passed its version of the FDA user fee reauthorization bill last week with a vote of 96-1, and the House is expected to pass its version of the legislation today with broad bipartisan support.
AAHomecare members can find more information and get involved in shaping policy for this issue through the Medical Gases Council. For in-depth commentary on pending legislation and regulations, go to Analysis and Comments, Testimony & Official Statements.