Banning Epinephrine Inhalers: FDA Making It Harder to Breathe
Asthmatics face a deadline of December 31, 2011 to switch from using epinephrine inhalers to other prescription treatment methods under an order from the Food and Drug Administration.
At issue is the chlorofluorocarbons (CFCs) contained in the inhalers, which are subject to regulation by the Environmental Protection Agency (EPA). Although President Obama’s administration recently allowed a bypass of new ozone regulations at the EPA which were cited as too costly, the administration has announced no intention to allow an inhaler exception.
Gregory Conko, a senior fellow at the Washington-DC based Competitive Enterprise Institute, says this crackdown on inhalers should not come as a surprise.
“The phase-out of asthma inhalers with CFC propellants has been going on since 2008, so the recent withdrawal of over-the-counter Primatene Mist was not surprising. Nor was it the first,” Conko said. “It’s also not surprising, although it is worrisome, that FDA would insist on their withdrawal for environmental reasons.”
In a press statement, the FDA said the ban on CFC inhalers is required under the Montreal Protocol on Substances that Deplete the Ozone Layer, which the U.S. signed in 1987.
Exception Allowance Ignored
Conko says several other prescription inhalers powered with CFCs that were arguably more important therapeutically have already been withdrawn.
“The Protocol allowed for a long and gradual phase-out of CFCs over the past 20 years in order to encourage the development of alternative products, but it does allow for exceptions to the phase out for ‘essential uses’ when there is no acceptable substitute propellant,” Conko said.
Trivial Amounts of CFCs
Even if you assume they have an environmentally negative impact, the amount of CFCs used by inhalers are minimal, Conko notes.
“Even if you buy into the belief that CFCs should have been phased out for general uses in refrigeration and other industrial processes in order to spare the ozone layer, the amount of CFCs used in asthma inhalers was trivial in the overall context of things,” Conko said.
Inhaled epinephrine has been on the market since before 1962, when FDA’s regulatory authority was substantially increased. Conko notes the product’s market approval was essentially grandfathered in.
“It would have been difficult for FDA to get it off the market through normal channels,” Conko said.
Alternatives’ Quality a Concern
Some types of inhalers, particularly ones containing albuterol, have been able to switch from CFCs to hydrofluoroalkanes (HFAs). But HFAs are fairly expensive, so not every product has been switched.
“Over-the-counter Primatene Mist just would not have been able to sustain the far higher price necessary to justify the switch to HFAs,” Conko said. “In many other cases, prescription inhaler manufacturers have been able to reformulate their products from aerosolized liquids that require a propellant to fine powders that require no propellant.
“That’s why FDA thought it was okay to phase out the CFCs: because manufacturers have alternatives available. It’s just not clear that the alternatives are as good,” Conko added.
A Public Health Negative
Conko says inhaled powers work for the majority of patients, but there have been numerous reports from people with severe asthma saying the inhaled powders are less effective.
Thus, “The CFC phase-out is troubling,” Conko said. “And I would argue that FDA should have taken advantage of the essential use exemption to keep CFCs available for these uses by those with severe asthma.”
Those suffering from asthma may be hurt by these regulations because the rules take a product off the shelves, Conko notes.
“The one really good thing about over-the-counter epinephrine inhalers is that asthma sufferers who run out of their prescription medicines at night or over the weekend or while on vacation, when a doctor wasn’t available to re-fill their prescriptions, could always go to a pharmacy and buy a product like Primatene Mist right away with no prescription,” Conko said. “Now they won’t have that option.
“And that’s not trivial,” he explained. “Severe asthma sufferers can die from their condition. And, although epinephrine inhalers do carry some significant health risks, having them available on the market almost certainly improved overall public health.”