The statement includes a reminder that albuterol inhalers provide an alternative to epinephrine but are available only by prescription. In addition, Dr. Leonard-Segal, reminds patients, “It is important to understand that albuterol HFA inhalers may taste and feel different than epinephrine CFC inhalers, and they have to be cleaned and primed so that they work in the right way.” Acknowledging that “replacement medicines for Primatene Mist may cost more,” she listed a variety of sources for discounts on albuterol inhalers.
In response to a question from a journalist about the magnitude of the cost difference, Leonard-Segal said it appeared that Primatene Mist was selling online for about $18 vs. about $45 for an average albuterol inhaler. Because no generic albuterol inhalers are available, even patients with health insurance may pay a substantial amount more for albuterol than they have been paying for OTC epinephrine.
None of the FDA representatives would comment on the status of Armstrong’s project to develop an HFA formulation of epinephrine that would be available over the counter or why it was not already available. Chowdhury noted that there is no technical barrier to reformulating the product and that the December 31, 2011 deadline had been based on Armstrong’s assertion that it could bring an HFA formulation to market by that date. He also reminded the media that even if there was such a product, that there would be no guarantee that the pricing would be lower.
When a reporter inquired about when a generic albuterol inhaler might become available, Chowdhury responded, “From a public health standpoint, we would be optimistic and supportive if a generic was to come.” However, he cautioned that they should “keep in mind that these are very complex dosage forms, and bringing a generic to market is not a very easy endeavor.” The CFC-propelled generic albuterol inhalers that were available prior to the switchover did not come onto the market until “multiple years after the exclusivity and patents were gone,” he noted.
Asked if some patients would say that they don’t get the same relief from an albuterol inhaler as they did from Primatene Mist, the FDA reps conceded that it was likely that some patients would complain but hastened to add that the FDA only approves drugs that are safe and effective.
By the end of the business day, many major newspapers had yet to publish anything about Primatene Mist on their websites, and the AP article printed in others focused on the higher price patients will pay for saving the ozone layer (OTC inhalers to be phased out to protect ozone layer). Others offered alternatives to the albuterol inhalers recommended by the FDA. A column in the San Diego Examiner titled “Primatene Mist is off the market. Asthmatics can choke on it!” offers albuterol inhalation solution as an alternative, and an NPR article (End Is Nigh For Over-The-Counter Inhalers That Eat The Ozone Layer) reminds readers that leukotriene inhibitors may be a viable option.
