US legislators are calling on the US Food and Drug Administration (FDA) to create a more predictable pathway for innovators and inventors of medical gases, saying the agency's most recent draft guidance document on the subject fails to clarify whether it will guarantee or merely "take into account" a gases' innovative status under an investigational new drug application.
Medical gases, such as oxygen, nitrous oxide and nitrogen, are most often used alongside medical devices, and often in hospital settings. The agency has long regulated the enclosures for medical gases, but it has only recently been granted the authority to regulate the gases.
Section 576 of FDASIA permits anyone to request that FDA certify designated medical gases for "certain indications listed in the [FDASIA] statute," and FDA's draft guidance is aimed at determining which products would qualify under the certification process, what that process will look like and how the agency will exercise its enforcement discretion over medical gases.
The previous section, Section 575, gives FDA the authority to certify a medical gas a "designated medical gas."
But the section also says FDA needs to take into account "any investigational new drug application or investigational 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."
FDASIA gave FDA a deadline of 5 January 2013 to release draft guidance on the topic, and on 14 December 2012 it released Certification Process for Designated Medical Gases, endorsed by FDA's Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).
The draft guidance looks to have FDA regulate oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide and "medical air that meet the standards set forth in an official compendium."
Please see Regulatory Focus' 17 December 2012 story, "FDA Outlines Certification Process for Certain Medical Gases" for more information.
A 20 December 2012 letter from Congress-just posted in the Federal Register by FDA-and signed by five senators, however, finds the guidance to be sorely lacking.
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.
And that has manufacturers worried.
That's because without the ability to protect their first-mover and investment into getting a gas certified, any company will 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.
Continued the legislators, "If the FDA designates a medical gas when an IND is pending, it could cause substantial losses for the company that filed the IND, subsequently thwarting its future investments in innovation and development and potentially causing a loss of jobs. [We] strongly encourage the FDA not to list medical gases with pending and legitimate INDs."
FDA, they said, should "provide regulatory certainty" and protection for innovators by clarifying the guidance document to "provide more stability for companies with pending INDs and those that are looking to invest in research and development for new medical gases."
The letter was signed by Sens. Chris Coons, John Cornyn, Thomas Carper, Kay Bailey Hutchinson and Richard Blumenthal.