H.R. 6190, introduced by Reps. Michael C. Burgess, M.D. (R-TX) and Mike Ross (D-AR), directs the EPA to allow the distribution of remaining inventories of the asthma inhaler known as Primatene Mist. For decades, this inhaler was sold without prescription but was banned from sale in the U.S. effective December 31, 2011.
Epinephrine inhalers containing chlorofluorocarbons (CFCs), most commonly marketed as Primatene Mist, have been sold in the U.S. for nearly 50 years. These over-the-counter inhalers have been phased out, however, in the U.S. under the Montreal Protocol and Title VI of the Clean Air Act. A ban on the inhaler went into effect on December 31, 2011, and to date, no over-the-counter replacement is available. An estimated two million asthma sufferers in the United States relied on this medication before the ban went into effect.
There is currently a remaining inventory of approximately one million inhalers. This legislation would direct the EPA to allow for the distribution and sale of the remaining inventories of the inhaler without threat of EPA enforcement actions.
What it WILL Do:
- The Act, which sunsets on August 1, 2013, would direct EPA to:
- Allow for the distribution, sale, and consumption of remaining inventories of CFC epinephrine inhalers, commonly known as Primatene Mist;
- Refrain from taking any enforcement action against any distributor or seller on the basis of any Federal law implementing the Montreal Protocol; and
- Issue a No Action Assurance Letter to any requesting distributor or seller stating the agency will not initiate such an enforcement action.
What it WILL NOT Do:
- Does not amend the Clean Air Act.
- Does not change the environmental protections in the Montreal Protocol.
- Does not limit FDA’s authority to ensure the safety and effectiveness of the remaining inventory of inhalers.
- Does not authorize manufacture of new CFC inhalers.