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FDA is considering how to deal with the phaseout of chlorofluorocarbons from inhalers, which is only a year away.
The Allergy and Asthma Network Mothers of Asthmatics (AANMA) is asking the agency not to grant the extension, saying that asthma sufferers who use the over-the-counter product should transition to prescription products. According to FDA, epinephrine MDIs are the only MDIs for treatment of asthma, or any other disease, approved for OTC use.
The organization's comments came in an hour-long hearing at FDA offices in Rockville, Md., last month. The meeting focused on the agency's proposed rule, published in the Federal Register September 20, to prohibit CFC use in the product after 2010.
Robert M. Sussman, counsel representing Armstrong Pharmaceuticals at the recent FDA hearing, said that the extra year will provide sufficient time for development and approval of an OTC non-ozone-depleting based epinephrine "and eliminate a one-year gap in which there is no OTC epinephrine formulation on the market."
"We recognize that epinephrine MDI is not the drug of choice for physicians treating asthma patients. Nonetheless this product serves a vital role in serving this patient population and is relied upon by as many as 1.7 to 2.3 million people with asthma," Sussman said.
He pointed out that "FDA has estimated that between 9% and 14% of OTC epinephrine users face barriers to health care," indicating that it may be difficult for those people to see a physician or obtain prescription medications.
FDA itself said, in the announcement of its proposed rule, "We believe that a small population of people with asthma who face barriers to health care may derive some benefit from having epinephrine MDIs available OTC." The agency is "keenly interested" in the public health effect and costs that may result from the removal of OTC epinephrine MDIs.
The agency also said that if the OTC epinephrine product were forced off the market, it would present a huge education challenge for patients who use it. Information might need to be disseminated through physicians, pharmacists, and other healthcare professionals or through literature for those professionals to hand out. But some of the OTC purchasers, said FDA, may not interact with a healthcare professional and some may need help finding a physician.
On the other hand, Nancy Sander, president of AANMA, presented data at the hearing from surveys her association had done at medical conferences, showing that the OTC product is not recommended by most physicians. The association's data indicated, for example, that 61% of physicians surveyed from the American College of Allergy, Asthma, & Immunology agreed with the statement, "OTC epinephrine inhalers are outdated therapy – the duration of action is short-lived and has unnecessary cardiac stimulation."
The organization also asserted that lack of healthcare access is not a significant issue with users of the product, since its survey of those patients showed the vast majority are insured and have access to prescription medications.
THE AUTHOR is a writer based in the Washington, D.C., area.