Pharma’s Cutting Edge

OTC drugs in the U.S. have been making news lately: cough medicines, orlistat, and inhaled epinephrine. For me personally the epinephrine story is particularly gratifying. A brief anecdote to explain. Some 13 years ago I treated a patient who was severely harmed by repeated use of OTC epinephrine MDI; she developed refractory atrial flutter resulting in severe congestive heart failure and nearly died. It was a classic case of OTC epinephrine MDI misuse. She was a poor woman without adequate healthcare. She never went to a doctor to receive appropriate asthma treatment. Incensed that a powerful and potentially dangerous drug like epinephrine was available to anyone without a prescription, I wrote a plea to FDA requesting that the drug’s OTC status be revoked. Surprisingly, I received a relatively rapid written response from Carl Peck, who was then a senior policy executive at the agency. The response was voluminous, consisting of a portfolio of materials that purportedly demonstrated support for the continued marketing of the drug OTC. Interestingly, Dr. Peck noted that no company had applied for a prescription version of the product. I reviewed the book of materials and was left with the same impression as when I had made my plea: there was a dearth of data that could support safe use of an OTC version of this drug. At that point I became derelict in my public-health responsibility and dropped the issue.

It wasn’t until mid-2004 when I noticed that the issue had re-surfaced, at the FDA’s Pulmonary-Allergy Advisory Committee. They discussed whether albuterol MDI containing CFCs required an essential use designatieon, which had become required for continued marketing of CFC-containing MDI-delivered drugs under a 2002 amendment to the U.S. Clean Air Act. By July 2005, this committee had recommended removal of most CFC-containing MDIs.

Yesterday’s advisory committee meeting continued this wave of CFC-containing MDI removals with the split vote (11 to 7) indicating that OTC epinephrine MDIs are no longer essential to the practice of medicine. The vote wasn’t not a complete victory for opponents of OTC epinephrine MDIs, because the committee was not asked to vote explicitly on the safety and advisability of OTC availability of epinephrine in the absence of CFC propellant. Nevertheless, the committee did discuss the dangers of OTC epinephrine per se, both direct, via harmful effects on the cardiovascular system, and indirect, via absence of appropriate doctor-guided therapy. They also vindicated my long-held view that adequate clinical studies demonstrating safety and efficacy of the product were never performed (and were likely never would be). The bottom line: OTC epinephrine MDI does not have a long shelf life remaining in the U.S. Chances are good that once it’s off pharmacy shelves it won’t ever return.