Primatene Mist Chances To Remain On Market Dwindle With Senate Vote
This article was originally published in The Tan Sheet
The Senate rejected a proposal to keep OTC asthma treatment Primatene Mist on the market while Armstrong Pharmaceuticals reformulates the inhaler without an ozone-depleting propellant.
The Senate Nov. 1 voted down South Carolina Republican Jim DeMint’s amendment to FDA’s fiscal 2012 appropriation, in a 54-44 vote, almost strictly along party lines.
FDA expected an alternative OTC inhaler to be ready before Primatene Mist, the only currently available nonprescription product, is removed from the market at the end of 2011. The agency had extended the deadline from the end of 2010 after Armstrong said that with another year to work it would be ready with an alternative formulated without chlorofluorocarbons.
In October, Sen. Pat Roberts, R-Kan., introduced the Freedom to Breathe Act, S. 1752, to keep the existing Primatene Mist on the market until Armstrong launches a replacement epinephrine inhaler formulated without a CFC propellant.
Roberts’ legislation has not moved since it was referred to the Health, Education, Labor and Pensions Committee and the issue likely will not generate further attention in Congress this session.
A DeMint spokesman said the senator supports Roberts’ bill, but “forced a vote on his amendment to ensure the opportunity to address the issue before the ban goes into effect in January.”
Roberts also looked to the amendment as the likely last chance for the Senate to act on delaying the removal of the only OTC asthma treatment.
After DeMint began his remarks during floor debate, Roberts asked the presiding senator to bring the chamber to order. “This is a very important amendment,” Roberts said.
Armstrong, a subsidiary of Rancho Cucamonga, Calif.-based Amphastar Pharmaceuticals, recently said it was in phase III clinical trials for its CFC-free epinephrine inhaler and expects to file a new drug application with FDA in the first half of 2012 .
DeMint argues that the language in FDA’s 2008 final rule
for phasing out CFC-formulated inhalers shows that “banning OTC inhalers will do little to nothing to affect the ozone.”
The problem caused by ozone-depleting substances “will be solved without the FDA enforcing” its rule to remove CFC-propelled inhalers from the market. – Sen. Jim DeMint
“My amendment just keeps this rule from going into effect until the manufacturer can complete its work with the FDA to change its propellant,” DeMint said during debate. The problem caused by ozone-depleting substances “will be solved without the FDA enforcing this rule,” he added.
GOP Cites Small Emissions Reduction
In the final rule, FDA said the withdrawal of OTC epinephrine metered-dose inhalers from the market will reduce CFC emissions worldwide by approximately 70 tons annually.
However, the agency explained that removing OTC CFC-powered inhalers from the U.S. market “represents only a fraction of 1 percent of total global CFC emissions.”
Additionally, U.S. CFC emissions from metered-dose inhalers “represent a much smaller, but unknown share of the total emissions reduction associated with [the Environmental Protection Agency’s] estimate of $6 trillion in benefits, because that estimate reflects future emissions growth that has not occurred,” according to FDA’s final rule.
While Republicans pushed to extend the availability of CFC-powered inhalers, Democrat Barbara Boxer pointed out during debate on the amendment that the change was started and made under Republican presidents.
Ronald Reagan signed the international environmental treaty on curbing ozone-depleting substances and federal agencies under George W. Bush adopted rules to make the change in the U.S., Boxer noted.
The California senator also pointed out that the American Lung Association and the American Thoracic Society support removing OTC asthma products from the market (Also see "No Relief In Sight For Future Of OTC Asthma Products" - Pink Sheet, 24 Aug, 2009.).
Prescription asthma therapies formulated as pills and inhalers will remain available. Rx inhalers, with the active ingredient albuterol, are formulated with non-ozone-depleting hydrofluoroalkane as a propellant.