HomeWashington Letter2014 ▶ ATS Comments on FDA Advisory Panel Review of OTC Epinephrine
ATS Comments on FDA Advisory Panel Review of OTC Epinephrine

February 2014

This week, the joint FDA Pulmonary Allergy Drug Advisory Committee and FDA Non-Prescription Drug Advisory Committee voted against approval of epinephrine HFA for over the counter use.  The final vote was 6 for, 18 against.

The ATS provided comments during the public input part of the meeting that noted the potential positive role an OTC product for asthma could play, but expressing concerns with epinephrine. The ATS further commented that if the panel chose to put ATS's concerns with epinephrine aside and approve it for OTC, then the ATS recommend an integrated dose counter, limits on the number of actuations and a strong warning label on the product.

Panel members who supported OTC epinephrine HFA felt the decades of experience with epinephrine – observing little or no adverse events – was compelling evidence to support OTC epinephrine HFA.

For those who voted against it, there were several issues that gave panel member concerns.  While there was essentially no debate on the effectiveness of epinephrine as a bronchodilator, there was much discussion on the safety of the drug, the reliability of the drug delivery mechanism and dose indicator, lack of appropriate support studies for the product, concerns with timeliness and completeness of the data supplied by the sponsor, lack of appropriate testing in ages 12-17, and concerns with proposed product labeling.

The recommendations of the advisory committee are not binding on FDA, but it is unusual that FDA would go against the recommendations of the advisory panel on a 3-1 vote.

Last Reviewed: October 2017