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Mr. PALLONE. I thank my colleague, the ranking member from California (Mr. Waxman).
Congress gave the FDA the responsibility of deciding whether specific types of inhalers containing ozone-depleting substances are essential uses and need to remain on the market, and the FDA has established an orderly and open process for making these determinations: 13 types of inhalers containing CFCs were phased out prior to the phase-out of Primatene Mist. The remaining two CFC-propelled inhalers are scheduled for phase-out at the end of 2013.
The FDA determined in 2008 that Primatene Mist was not an essential use. They concluded that there are no substantial technical barriers to developing epinephrine inhalers that do not release ozone-depleting substances. At the request of Armstrong, the manufacturer of Primatene Mist, the FDA set a phase-out date of December 31, 2011, which was 1 year longer than the FDA initially proposed. The FDA took steps to prepare the public for the phase-out. It approved a label for Primatene Mist which indicated to consumers that Primatene Mist would not be available after December 31, 2011, and Primatene Mist was phased out on that date. It has not been available for the past 11 months.
This bill would intervene to put Primatene Mist back on the market. It is a legislative earmark that directly benefits just one company--Armstrong. A long list of public health groups, physician organizations, and patient advocates oppose this bill. They do not believe that returning Primatene Mist to the market is in the best interest of patients with asthma or in the best interest of public health. The following organizations, Mr. Speaker, that oppose this bill wrote to Members of the House: the American Lung Association, the American Thoracic Society, the American Academy of Pediatrics, the Asthma and Allergy Foundation of America, Mothers of Asthmatics.
I could go on. There are eight other public health organizations on this one letter alone, and I am not aware of any public health organization that supports this bill. When FDA officials briefed Members, they expressed many of the same concerns about patient confusion and of Primatene Mist no longer being the standard of care for asthma patients.
Now, let's be clear, Mr. Speaker. Every public health group and patient advocacy group that has looked at this bill has concluded it is a bad idea. Congress shouldn't be overriding FDA's established regulatory process if doing so would pose significant patient confusion and undermine public health. That's just common sense.
Even if we pass this bill, it would not lead to the widespread availability of Primatene Mist that is sought by the proponents of the legislation. According to Armstrong, between 2 million and 3 million people used Primatene Mist before the phase-out, but fewer than 1.5 million Primatene Mist inhalers remain in Armstrong's inventory. That means that as many as half of all previous users of Primatene Mist would not be able to obtain even one inhaler if Armstrong were allowed to sell off its remaining inventory, and it assumes that pharmacies or drug stores would even carry it. Retailers may decide not to sell inventoried units of Primatene Mist because the units will start to expire in January, and that's only a few weeks from now.
So the real effect of this bill would be to provide a regulatory earmark to Armstrong rather than a rescue inhaler that would be available in the middle of the night to someone suffering from an asthma attack.
Mr. Speaker, I don't know what else I can say. This is a bad bill, and I urge my colleagues to oppose it.
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