Primatene Mist Denied Comeback
December 13th, 2012 // 2:04 pm @ jmpickett
After months of anticipation, the US House of Representatives late yesterday voted down a bill that would have permitted Amphastar Pharmaceuticals to return the Primatene Mist over-the-counter asthma inhaler to the US market in order to sell off its inventory of some 1.5 million units. The vote was 229-to-182.
The move is a setback to the drugmaker, which hoped to empty its warehouses while approval is sought and, presumably, finalized to sell a new version without chlorofluorocarbons, or CFCs. For those who may not recall, Primatene Mist inhalers used CFCs, which decrease the ozone layer. The US signed an international agreement to phase out CFCs and other ozone-depleting substances.
As a result, in late 2008, the FDA finalized the phase-out date for using CFCs in asthma inhalers and notified the public of its intentions (read more). The FDA had also warned Amphastar about the looming ban, which took effect last December 31, but the drugmaker never created a follow up product that did not contain CFCs.
The drugmaker maintained its effort to pass legislation was not designed to generate additional profits, but to offer a choice to consumers who lack the insurance coverage that helps them pay for prescription inhalers. Toward that end, Amphastar launched a Facebook page in a bid to generate consumer pressure on legislators (here it is), while insisting any profits from temporary Primatene Mist sales would be given to charity.
The run-up to the vote, meanwhile, energized many patients who clamored for the inhaler (back story with lots of comments here). But the bill, known as the Asthma Inhalers Relief Act of 2012 (read here) faced opposition from more than a dozen medical societies, including the American Lung Association, the American Thoracic Society.
These groups argued that epinephrine, which is the active ingredient in Primatene Mist, can cause adverse cardiovascular events, such as heart attacks. Last summer, Monica Kraft, who heads the, Duke University Asthma, Allergy and Airway Center, and is also president of the American Thoracic Society (which runs a foundation supported, in part, by drugmakers that sell prescription inhalers), testified against allowing Primatene Mist to return temporarily.
“If the intent of the legislation is to restore a safe and effective asthma drug to the marketplace, then this legislative effort is mis-informed. Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented. No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma†(here is her testimony).
Passage, by the way, required a two-thirds majority of those present, not an out-and-out majority, because voting took place under suspension. This refers to a move by the House to suspend the usual rules in order to dispense as quickly as possible with voting, usually for bills that are not deemed to be controversial.
