Environmental concerns prompted a ban on the sale of the inhalers at the end of last year but the manufacturer, Amphastar, still has 1m in a warehouse. With the inhalers due to expire next year - and no over-the-counter alternative available - Amphastar is pushing for a policy shift.
The proposed shift takes the form of the recently introduced Asthma Inhalers Relief Act 2012. “If the bill passed we could get the inhalers back on the market in several days,” Jason Shandell, vice president and general counsel at Amphastar, told in-PharmaTechnologist.com.
Republican Michael Burgess is behind the Bill. A House subcommittee met to discuss the Act, which would allow Amphastar to sell its remaining stock of the drug, Primatene Mist, last week and passed it on a voice vote.
The Act now goes to the full committee where Burgess will continue to seek support. Burgess, an asthmatic, introduced the Act after becoming dissatisfied with responses from US Food and Drug Administration (FDA) officials he has questioned at hearings throughout the year.
Speaking at a meeting to discuss his proposed legislation last week Burgess accused the FDA and US Environmental Protection Agency (EPA) of engaging in an “elaborate deception.” The accusation stems from Burgess’ belief the FDA and EPA have failed to answer his questions.
While there was support for the Bill in the subcommittee, particularly from Republicans, some experts who spoke to the Congressman were strongly opposed to resuming sales of inhalers.
Monica Kraft, president of the American Thoracic Society, spoke out against the legislation on the grounds that the OTC inhaler has side effects and gives users a false sense of wellbeing.
Industry had other objections. Democratic Congressman Henry Waxman said: “Companies that already made the necessary investments in developing CFC-free inhalers say there’s no justification for this bill as it provides special treatment to a single company.”
Amphastar is working on a HFA-propelled version of its epinephrine metered-dose inhaler but is yet to receive FDA approval. Shandell told the subcommittee Amphastar has “great” Phase III trial data and plans to submit a new drug application to the FDA in the fourth quarter.
If the law is passed Amphastar says it will give net profits from the sale of the inhalers to charity. Passing up on the $6.5m (€5.3m) Amphastar says it could make from the 1m inhalers counters claims the company is trying to change the law simply to boost its profits.
Amphastar still stands to benefit from the revised law though. If Amphastar is unable to sell the 1m inhalers it must dispose of them and, at this stage, the the cost and conditions of this step are unclear.
“Our counsel, Former Congressman Bart Stupak, sent an email to EPA in March asking for details on disposal. To this day, he has not received a reply from EPA as to this question,” Shandell said.