The US Food and Drug Administration (FDA) may need to revise its drug regulatory framework to allow it to better accommodate the approval process for medical gases, and is calling on members of industry and the general public to help it to determine what-if any-changes are necessary.
Medical gases, such as oxygen, nitrous oxide and nitrogen, are most often used alongside medical devices, and often in hospital settings. FDA has long regulated the enclosures for medical gases, but it has only recently been granted the authority to regulate the gases under the FDA Safety and Innovation Act (FDASIA) of 2012.
Section 576 of FDASIA permits anyone to request that FDA certify designated medical gases for "certain indications listed in the [FDASIA] statute," while the previous section, Section 575, gives FDA the authority to certify a medical gas a "designated medical gas," thereby bringing it under its jurisdiction.
Another portion of the law allows FDA to consider whether changes to the regulatory framework are necessary to accommodate medical gases, which would be regulated under FDA's drug regulations.
"Section 1112(b) provides that if the Secretary determines that changes to the Federal drug regulations are necessary for medical gases, the Secretary shall issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the enactment of FDASIA," FDA explained in a Federal Register posting.
FDA said it is now collecting comments from industry and the general public regarding whether changes are needed to existing regulations. Those comments will form the basis of an eventual report to the House and Senate committees that regulate FDA on the necessity of changes, and the FDA commissioner would then be allowed to issue final regulation revising the federal drug regulations.
Guidance and Legislator's Criticism
In the meantime, FDASIA instructed FDA to issue a draft guidance document establishing the certification process by which certain medical gases can be brought to market, which it did in December 2012.
The draft guidance, and FDA's interpretations of the legislation therein, have attracted some considerable scrutiny from legislators in recent weeks. In late February 2013, several legislators wrote to the agency expressing concern that a line in the legislation had the potential to be taken out of context and incorrectly implemented.
The legislation states that regulations need to "take into account … any investigational new drug application or investigation new animal drug application for the same medical gas submitted in accordance with regulations" to ensure that they are not subject to "any period of exclusivity."
But those words-"take into account" in particular-don't actually say whether FDA needs to reject any application that impedes upon a period of exclusivity, or whether it just needs to acknowledge their existence.
FDA has not yet responded to the legislator's concerns, but they are likely to be repeated if or when FDA issues its report on medical gases to those same legislators later this year.