There are the regulations well-known to life science companies-those of the US Food and Drug Administration (FDA), for example. Then there are those regulations of lesser notoriety, though potentially of no less consequence.
A bill introduced in the US House of Representatives on 25 July by Rep. Michael Burgess (R-TX) speaks to the impact of one of those lesser-known regulations. Burgess's bill directs the Environmental Protection Agency (EPA) to allow for the "distribution, sale and consumption" of over-the-counter (OTC) epinephrine-based asthma inhalers containing chlorofluorocarbons (CFCs), a propellant used to discharge epinephrine from the device.
An Environmental Regulation
CFCs have been blamed for causing massive holes in the Earth's ozone layer, and a 1987 agreement known as the Montreal Protocol phased in the eventual removal of the products from signatory countries' markets. The US was a signatory to the agreement, and by 2006 both EPA and FDA were working to implement the treaty's rules.
One of the few products to be affected by the ban was Primatene Mist-an OTC inhaler used by millions of asthmatics in lieu of more expensive prescription albuterol inhalers.
The product costs approximately $20, while prescription albuterol products can cost upward of two times as much-and that's not counting the trip to a prescribing physician to obtain permission to get the product.
FDA and other health officials worked for years to both warn consumers and get manufacturers to switch to an alternate propellant, but to limited success. While the products were originally scheduled to be phased out in 2008, EPA extended the deadline for the product until 1 January 2012, at which time stock of the product remaining on the market was subject to seizure and penalties.
A New York Times report in April 2012 also explained the product has been the flashpoint of tensions between FDA and the Obama administration, with FDA officials arguing the product's manufacturer had been given multiple extensions and, "Had not followed other inhaler makers [to make] a product that did not use CFCs."
Instead, notes The Times, manufacturer, Amphastar, "Underwrote an expensive lobbying campaign to stop the FDA's planned ban."
White House officials, including chief regulatory officer Cass Sunstein, director of the Office of Information and Regulatory Affairs, would argue on behalf of giving the product a reprieve. FDA officials resisted internal pressure, and the product was withdrawn from the market on 1 January.
The AIR Act
Burgess has lambasted the agency for the product's removal since at least early 2012. In a February 2012 House of Representatives hearing involving FDA Commissioner Margaret Hamburg, Burgess said the cost of the inhalers would hurt consumers by driving up the cost of care, particularly by requiring the intervention of a doctor. Hamburg meanwhile welcomed the intervention of physicians, saying the Primatene inhalers were inadequate to control asthma and the condition needs to instead be controlled through adequate drug therapy and the help of a physician.
Burgess this week went one step further, offering his Asthma Inhalers Relief Act of 2012 (AIR Act) to allow the distribution, sale and consumers of the epinephrine inhalers by prohibiting EPA from taking enforcement actions against manufacturers, distributors or consumers.
The act would only be in effect until August 2013.