The US Food and Drug Administration (FDA) is announcing an upcoming meeting intended to solicit input on whether new changes to its medical gases regulations are necessary, giving an opportunity to members of industry who have long and loudly complained that the current regulatory structure does not meet their needs.
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 Food and Drug Administration 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, Section 1112(a), requires FDA to, within 18 months of the enactment of FDAISA, determine if changes are necessary to existing regulations pertaining to medical gases.
If those changes are determined to be necessary, Section 1112(b) requires FDA to "issue final regulations revising the Federal drug regulations with respect to medical gases not later than 48 months after the enactment of FDASIA."
Since that March 2013 posting, FDA has been collecting comments from industry and the general public regarding whether changes are indeed necessary, which it said would help inform an eventual report to Congress on the necessity of those changes, as well as an eventual regulation if it was determined to be necessary.
Industry Weighs In
And though the gas industry's products are light, its comments to FDA have been weighty.
The Compressed Gas Association (CGA), an industry trade group, told FDA that the current regulations need to be re-written not only for medical gas firms, but for "all drug firms" as well. The group said a number of issues in this area were unclear, such as whether gas firms would need to update drug listings once they received drug registration numbers and how labeling information would work with respect to their products.
Further, it said there is currently a lack of clarity surrounding the status of medical gas drug listings "completed prior to the designated medical gas certification process." At present, those products are considered unapproved drugs. "How does the Agency intend to correct this for original and subsequent manufacturers as well as persons manufacturing mixtures of designated medical gases?" asked CGA.
In addition, CGA said that all firms are currently required by FDA to register facilities using an electronic registration system, despite the regulation (21 CFR 207) requiring written submissions. This, too, needs to be updated, it said.
Other concerns have been raised in the past as well. Several legislators wrote to FDA in March 2013 expressing concern that a draft guidance issued by FDA could have the effect of destabilizing the market for medical gases.
When authoring the medical gases section of FDASIA, the legislators wrote, it was their intent to "create a predictable environment where companies, universities or research coalitions could bring their medical gases to market, protect their research and realize their investment-benefiting patients and healthcare providers while protecting good jobs." But the draft guidance doesn't do that, they argue.
They note that since the publication of the draft guidance, "Medical gas companies in our states have expressed concern about how the FDA will interpret the phrase 'taking into account.'" Depending on the agency's interpretation, it could either mean a guarantee, or simply a non-binding consideration that leaves the agency open to its own discretion.
Without the ability to protect their first-mover status and investment into getting a gas certified, legislators observed that any company would be able to immediately swoop in and offer a generic gas product at a fraction of the cost because they won't have to recoup research investment. Similar protections are afforded to pharmaceutical, medical device and biological products, as well as first-to-file generic products, which can get 180 days of marketing exclusivity.
It is unclear if FDA will address these comments on its guidance as part of its potential overhaul of the medical gas regulation, or if it will be addressed separately.
Whatever its approach, industry will have a chance to meet with FDA on 6 December 2013 when the agency holds a public meeting to discuss whether changes are needed to the medical gas regulations.
The meeting will also be available via webcast, FDA said.
Federal Register Notice