Regulatory Focus™ > News Articles > House Prepares to Bring Up Bill Allowing Sale of Banned Asthma Inhalers

House Prepares to Bring Up Bill Allowing Sale of Banned Asthma Inhalers

Posted 12 November 2012 | By Alexander Gaffney, RAC 

House legislators are preparing to bring up a piece of legislation that would allow the limited sale of a type of over-the-counter inhaler that was banned in 2012 as the result of environmental regulations.

The bill, the Asthma Inhalers Relief Act of 2012 (AIR Act) would specifically apply to epinephrine-based asthma inhalers containing chlorofluorocarbons (CFCs)-a type of propellant used to discharge the epinephrine from the device. CFCs have technically been banned since the US signed on to the 1987 Montreal Protocol, an international agreement aimed at preserving the ozone layer.

Despite the Protocol's phase-out plan, it took until 2006 for the US Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to develop rules to implement the CFC phase-out. The primary problem for FDA was-and remains-the use of CFCs as a propellant. Millions of people with asthma use epinephrine-based devices like Primatene Mist, a relatively cheap OTC inhaler product, and prescription versions of the drug are generally more expensive even before the cost of a visit to a prescribing physician is factored in.

By 2008, both EPA and FDA's attempts to get all manufacturers to switch to different propellants had failed, with at least one-Amphastar, manufacturer of Primatene-underwriting a lobbying campaign against the proposed ban. Critics contended the amount of CFCs emitted by the products were insignificant and would be of no consequence to the ozone layer. Those arguments lost out, and on 1 January 2012, FDA finally acted to ban the products from the market.

Legislators, including Michael Burgess (R-TX), were furious, and pressed FDA Commissioner Margaret Hamburg on the issue at committee meetings and other venues, calling on her agency to postpone the ban for at least another year.

FDA has rebuffed those calls, and in July 2012 Burgess introduced the AIR Act in an attempt to overturn the ban until 1 August 2013. The bill would prevent FDA or EPA from taking any action based on the Montreal Protocol, and would similarly allow for the legal distribution, sale and consumption of all remaining inhalers. New ones, however, would not be permitted to be manufactured.

The House of Representatives is set to bring the bill up for consideration once it returns from its election recess on Tuesday, 13 November. It will recess again on 16 November for Thanksgiving  before returning on 27 November.

It remains unclear whether the bill would see success in the Senate, particularly with just a few weeks left in the legislative calendar. Also unclear is whether President Barack Obama would sign the bill if it came to his desk. According to the New York Times, the issue was a flashpoint of tension between his administration and FDA, implying that the bill might garner support at the White House.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe