The leadership of the U.S. House of Representatives has again scheduled a vote, tentatively tomorrow, on legislation to bail out the maker of the banned, ozone depleting Primatene Mist. http://majorityleader.gov/Floor/
For some quick background, see http://blogforcleanair.blogspot.com/2012/11/ozone-alert-congress-comes-back-and-one.html
Other drug makers now have written to Congress, urging defeat of what can only be described as a smelly, special-interest bailout bill. Here is the letter:
U.S. House of RepresentativesWashington, D.C. 20515
On behalf of the International Pharmaceutical Aerosol Consortium (IPAC)—an association of companies that manufacture medicines for the treatment of respiratory illnesses, such as asthma and chronic obstructive pulmonary disease (COPD)—I am writing to you today in opposition to H.R. 6190, the “Asthma Inhalers Relief Act of 2012,” which is currently on the Suspension Calendar for Wednesday.
IPAC’s members are: AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Sunovion, and Teva. For more than 20 years, IPAC has been firmly committed to the transition from chlorofluorocarbon (CFC) metered-dose inhalers (MDIs) to CFC-free alternatives, pursuant to the mandates of the Montreal Protocol, and actively engaged in the transition process in the United States. IPAC’s member companies invested substantial resources to develop CFC-free alternatives in order to accomplish the phase-out of CFC-based MDIs.
IPAC strongly opposes efforts within the House of Representatives to lift the December 31, 2011 ban on the sale of CFC-based epinephrine (brand name: Primatene Mist) metered dose inhalers (MDIs) through H.R. 6190. Such a drastic reversal in settled law would be (1) unnecessary to protect the health of asthma patients and (2) contrary to the United States’ important and longstanding commitment to international treaties.
As you may know, the phase-out of Primatene Mist and other ozone-depleting MDIs was initiated more than two decades ago in response to the mandates of the Montreal Protocol which was signed by President Ronald Reagan in 1987. The “essential use” process under the Montreal Protocol and Clean Air Act provided the MDI industry ample time to reformulate and seek approvals of CFC-free alternatives. MDI manufacturers long ago began working diligently to research and develop CFC-free products in order to meet Montreal Protocol requirements. Most companies (including all IPAC members) invested hundreds of millions of dollars to accomplish this important objective. The attached timeline summarizes the extensive history of the essential use process and the careful, deliberative steps undertaken to promote a smooth and seamless transition to CFC-free alternatives.
The December 31, 2011 phase-out date for CFC-based Primatene Mist was established by FDA in 2008 (under the prior Administration), and was based upon an extensive administrative record that included input from key stakeholders, including patient and physician groups. This deadline provided three full years to transition patients to one of the several CFC-free alternatives available. It is noteworthy that the manufacturer of Primatene Mist specifically sought the December 31, 2011 deadline after an earlier deadline was initially proposed by FDA.
More importantly, the stockpiled Primatene Mist is nearing the end of its shelf life (assumed to be 24 months based on public data) and would, therefore, expire quite soon after being sold to patients. According to a recent Congressional letter to FDA, Armstrong ceased producing Primatene Mist in August 2011 – more than a year ago. Any remaining units sitting in a warehouse somewhere are rapidly nearing the end of their useful life.
It has been suggested that re-introducing Primatene Mist would be cost-effective for patients. A group of respected patient advocates directly disputes this assertion and they note that “two inhalations of epinephrine provide breathing relief ... for 15-30 minutes, whereas two inhalations of prescription bronchodilators, which is the recommended medication by NIH, last 3-6 hours with less unwanted cardiac stimulation. Primatene Mist is not a cheaper alternative.” (Allergy & Asthma Network Mothers of Asthmatics, et al, letter to Senators Pat Roberts and Jim DeMint October 28, 2011). In addition, patient assistance programs (and product samples) continue to be available to assist many users of Primatene Mist to successfully transition to safe and effective CFC-free alternatives.The only possible beneficiary of a reversal of the ban on Primatene Mist would be its manufacturer, which stands to garner a financial windfall if its limited stocks are sold. And, any patient buying these MDIs will be forced to switch therapy a second time once the stocks are depleted (which is likely to be within a matter of months). Granting extraordinary, unwarranted and special treatment to a single company would send an extremely negative signal to the manufacturers that responded to the U.S. Government’s call many years ago to be a partner in meeting the Montreal Protocol commitments. Similar, prior requests for deadline relief (including requests to sell small stockpiles of CFC MDIs) have been firmly denied by the relevant regulatory authorities.
Finally, there is no evidence that patient health will benefit from briefly re-introducing Primatene Mist onto the market, now almost one year after the ban became effective. Rather, as stated during the July 18th hearing on this bill, the clear consensus of the major physician and patient groups is that such an action would be extremely confusing and disruptive for patients and would not contribute to improved health outcomes. Tens of millions of asthma and COPD patients in the U.S. have successfully transitioned to CFC-free MDIs over the past 15 years.
IPAC respectfully urges you and your House colleagues not to support H.R. 6190, the “Asthma Inhalers Relief Act of 2012” and to ensure that the phase-out of CFC-based MDIs remains in effect so that patients and consumers are not subjected to unnecessary risks or uncertainty. For your reference, I have also included an attachment that provides you and your staff with a timeline for the phase-out of CFC-based MDIs. We appreciate the opportunity to share our views in this letter, and please be assured that IPAC stands ready to serve as a resource on this issue. If you and your staff have any questions about our letter, please feel free to contact me at (202) 230-5133 or Maureen.Hardwick@dbr.com.
Maureen Donahue Hardwick
IPAC Secretariat and Legal Counsel
IPAC Secretariat and Legal Counsel