Advocating for Drug Regulation Reform

Facing unintended consequences from FDA policies on unapproved drugs that could have removed common medical gases from the market, the Compressed Gas Association (CGA) turned to Holland & Knight's Public Policy & Regulation Practice Group to achieve a legislative solution. The historic reforms that resulted helped to avoid a potentially catastrophic result for the industry.

The use of medical gases pre-dates the new drug application (NDA) provisions in the Federal Food, Drug, and Cosmetic Act. Consequently, most medical gases were sold without NDA approval. As a result of the Unapproved Drugs Initiative — which the Food and Drug Administration (FDA) launched in 2006 to remove all unapproved drugs from the marketplace —medical gases such as oxygen, nitrous oxide, helium and medical air would either be removed from the market or would require new drug applications. Medical gases play a major role in the treatment of chronic obstructive pulmonary disease (COPD), anesthesia delivery, surgery, medical research and dentistry.

The CGA came to Holland & Knight to seek a legislative solution to prevent unexpected, detrimental results from the Unapproved Drugs Initiative. Our attorneys worked on behalf of the medical gas industry to draft bipartisan legislation, negotiate directly with the FDA and develop a final compromise that was supported by the FDA, the regulated medical gas industry and members of Congress. The legislative solution was incorporated into the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law by President Obama on July 9, 2012.

FDASIA brings about significant reforms in the way the FDA regulates drugs and devices. The law creates a new pathway for medical gases to become approved drugs and reforms current regulations to account for the unique characteristics of medical gases. The legislation also statutorily exempts medical gas manufacturers from FDA-approved prescription drug fees. The historic reforms Holland & Knight helped the CGA achieve will reduce the number of unnecessary regulations in this area, simplify the rules for medical gas providers and ensure that patients maintain their access to these life-saving medical gases.