Although in use for long before the birth of the FDA in 1938; medical oxygen had an initiative undertaken for its safe use only with the passage of The Medical Gas Safety Act by the FDA in 2006. It commenced with the start of what FDA called the 'Unapproved Drug Initiative', which bunched all kinds of medical gases under the broad category of 'unapproved drugs'. An unapproved drug is one for which the FDA does not formulate guidelines. With the passage of this bill into law in mid-2012, the FDA now brings medical gases under its belt and brings about a bouquet of changes into the existing law governing medical gases.
A slew of changes
One of the most important changes the Medical Gas Safety Act will bring about is that it exempts this industry from paying the FDA Drug User Fees. This will result in savings of millions of dollars for the industry. This is seen as a triumph of this industry's lobbying power.
Addresses major concerns
Another prominent difference this Act will bring about is that it addresses the major concern of gas manufacturers -that of storage of many medical gases like nitrogen, oxygen and others. A huge number of such gases whose use was previously unregulated will now be classed as Designated Medical Gas and be subject to regulation. These gases will have the FDA's regulations in relation to storage in whatever form they are stored -liquefied, non-liquefied, cryogenic or any other. Further, there will be greater clarity on other important issues like expiry date of gases.
From no regulation to nationwide regulation
The Act also removes ambiguity about the previously existent 'regulations' considerably. Actually, there were no FDA-led regulations for these gases, as we have seen. Their use was broadly and loosely governed by a number of individual guidelines that were set by different bodies. Now, the FDA will enact uniform, nationwide regulations for these gases' safe use.
IPR for the gas industry
The medical gases industry is likely to see more innovation in the future with the passage of this Act. Previously, gases were not subject to intellectual property rights. From now on, they will be. This removes a major stumbling block to creativity and novelty in this sector, as the absence of an IPR law stifled advancement. In addition, the new law also lays out a certification process when designated medical gases are to be produced.
Facilitates FDA-industry interface
This law also fosters far greater interaction between the industry and the regulatory body. It requires the FDA to consult the gas industry about any regulatory decisions and actions. It offers a framework to create or subsequently revise any regulation for the industry.
One reservation however, of the industry about this Act is that it sees the FDA's inclusion of carbon monoxide in the designated mixture list as anomalous. The FDA's rationale for including this gas in this list is that it is used for Lung Diffusion Test Mixtures. The industry sees an inconsistency in this because Lung Diffusion Test Mixtures are regulated under the classification of medical devices and not drugs, while some other gases used in Lung Diffusion Test Mixtures, such as neon and methane for instance, are not included in the designated gas list.