It provides an important public health benefit, there's no other OTC alternative to CFC epinephrine inhalers, and the environmental risk from the release of CFCs from Primatene is small and justified given the benefit it provides. |
Keeping in mind that this is only a recommendation, it doesn't mean the FDA will take this product off the market. We have asked [the FDA] for the opportunity to reformulate the product using a non-CFC propellant, which will take us about five years. We need to reformulate it and put it through clinical trials and then submit it to the FDA as a new drug for evaluation. |
We don't believe consumers would purchase and repurchase it if it didn't work for them. |