Frank Pallone: “I thank my colleague, the ranking member from California (Mr. Waxman). Congress gave the FDA the responsibility of…”

“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.…”