With the ban of Primatene Mist, the FDA has endangered the life of approximately 3 million American taxpayers who rely on the medication for relief of their asthma symptoms, and has brought the United States of America into non-compliance with international law.
In 1989, under the presidency of George Herbert Walker Bush, the United States became a signatory to the Montreal Protocol on Substances That Deplete the Ozone Layer. As a result, regulations governing the use of certain ozone-depleting substances, including chlorofluorocarbons (CFCs) became federal law.
In 2006, an FDA advisory panel voted 11-7 to recommend that the Federal Drug Administration (“FDA”) classify Primatene Mist (which uses a CFC-based propellant) as a non-essential product according to the guidelines established by Decision IV/25 of the Montreal Protocol, and thus not exempt from the ban.
We, the undersigned, state our belief that
1) The federal government of the United States of America in general, and the Food and Drug Administration in particular, have been unreceptive to good-faith requests that Primatene Mist CFC be classified as a medically essential product pursuant to Decision IV/25 of the Montreal Protocol on Substances That Deplete the Ozone Layer, defining the criteria for exemption for “medically essential” products containing substances regulated by the Protocol.
2) The federal government of the United States of America in general, and the Food and Drug Administration in particular, are in violation of the Montreal Protocol on Substances That Deplete the Ozone Layer; in particular, we believe that their actions with regard to Primatene Mist constitute a violation of Decision IV/25 in toto.
3) Primatene Mist should be classified as a essential-use product pursuant to Decision IV/25 of the Montreal Protocol on Substances That Deplete the Ozone Layer.
4) The Food and Drug Administration, at the behest of lobbyist groups including the Allergy & Asthma Network/Mothers of Asthmatics (hereafter referred to as "AANMA"), has ignored the informed medical opinions multiple medical experts who state that HFA propellants are less effective than CFC propellants in their decision to ban Primatene Mist, thereby endangering the lives of 3 million American citizens.
We, the undersigned, hereby acknowledge the following facts, ignored by all available federal literature on the implementation of Decision IV/25 of the Montreal Protocol on Substances That Deplete the Ozone Layer:
1) Total chlorofluorocarbon emissions from Primatene Mist inhalers are known to total less than 1% of the total amount of CFC emissions, the vast majority of which are the result of halocarbon CFC use in refrigerants and other non-medical uses.
2) Halocarbon refrigerants have no known medically essential use, yet many refrigerant compounds remain nearly unregulated by the federal government.
3) HFA propellants are known to deliver asthma-relieving medication less effectively than CFC propellants, according to the opinion of multiple medical doctors.
4) (a) 700,000 of the estimated 3 million users of Primatene Mist are reported to solely use over-the-counter treatments for their asthma. Of these 700,000, about 175,000 are uninsured. We believe that a substantial percentage of the remaining (insured) 525,000 "sole use" Primatene Mist users, comprise individuals for whom HFA-propelled medications have proven to be ineffective.
(b) As established above, because a substantial number of Primatene users, and their physicians, have found HFA-propelled medications to be totally uneffective, Primatene Mist, in its CFC-propelled form, constitutes a medically essential product for these patients, as defined by Decision IV/25 of the Montreal Protocol on Substances That Deplete the Ozone Layer. Thus,
5) Despite the FDA's ruling, Primatene Mist does constitute a medically essential treatment for an unknown but substantially large number of individuals.
6) Man-made ozone-depleting substances, including CFCs, are known to represent less than 1% of the total amount of ozone-depleting emissions, the vast majority of which are produced by natural processes.
7) The Food and Drug Administration failed to provide the required postmarketing information for both Ventolin HFA and Proventil HFA (required by 21 CFR 2.125(g)(3)(iii) and 21 CFR 2.125(g)(3)(iv)) establishing the safety and efficacy of the replacement inhalers prior to the ban of CFC-based albuterol inhalers. Thus, the ban has been perpetrated on grounds that are both deceptive and illegal.
8) The campaign against Primatene Mist, in which the AANMA has been complicit, has been carried out on accusations that are factually inaccurate according to the HFA inhalers’ own manufacturers. For example, a common “evidence” often cited in support of the ban of Primatene Mist is the possibility for CFC inhalers to cause a racing pulse and stomach upset. However, according to Schering-Plough, manufacturer of Proventil HFA, “Rapid heart beat, vomiting, chest pain and palpitation occurs more frequently with Proventil HFA (than with CFC albuterol).”
The truth is that, according to the pharmaceutical companies’ own clinical studies, HFA propellants are more dangerous and carry a higher risk of side effects than the equivalent CFC inhalers. In addition, patients have observed and issued formal complaints to the effect that HFA propellant is either less effective than CFC at delivering the same medication, or not effective at all.
By all accounts, the FDA made no attempt to expedite the approval process for Armstrong's Primatene Mist HFA, and repeatedly refused to delay the "sunset" date for Primatene Mist CFC until a replacement product could be approved. In doing so, the FDA has shown a wanton disregard both for asthmatics' civil rights and for any meaningful implementation of the term "essential use" as defined by Decision IV/25 of the Montreal Protocol on Substances That Deplete the Ozone Layer.
With the acknowledgement of these facts, we have no other conclusion to reach but that the Food and Drug Administration, under the advice of several lobbyist groups (including the AANMA), have been willfully blind and careless in their application of Decision IV/25 of the Montreal Protocol.
In summary, we believe that their actions in regard to Primatene Mist are totally unreasonable according to the logical interpretation of Decision IV/25 of the Montreal Protocol and that, due to their actions, the United States government has entered into non-compliance with the Montreal Protocol. As a result, the United States has become amenable to the procedures outlined by the Montreal Protocol's "Non-compliance procedure", as established by the Montreal Protocol in 1998.
In addition, the marketing and prescription of Proventil and Ventolin in their current, HFA-propelled form, is illegal according to present federal regulations.
In light of these observations, we, the undersigned, hereby demand:
1) The establishment of a congressional investigation into the FDA's current implementation of the Montreal Protocol on Substances That Deplete the Ozone Layer, focusing in particular on the official recognition of the term "essential use" as defined by Decision IV/25 of the Montreal Protocol.
2) An executive order or a binding act of congress suspending all currently active FDA plans to outlaw any medications which contain compounds regulated by the Montreal Protocol on Substances That Deplete the Ozone Layer, until such time as a timely, impartial, and transparent investigation by the FDA can determine whether or not those medications meet the definition of "essential use" as established by Decision IV/25 of the Montreal Protocol.
3) A re-examination by the Food and Drug Administration of all medications and medical-use products outlawed under the Montreal Protocol on Substances That Deplete the Ozone Layer, and in particular CFC-propelled asthma inhalers.
4) That the AANMA cease all deceptive campaigning in regard to inhaler propellants, and recuse itself from all future FDA inquiries into the safety and importance of said propellants.
As long as these steps toward compliance are not taken, we believe that the federal government of the United States of America remains in non-compliance with the Montreal Protocol on Substances That Deplete the Ozone Layer, and is amenable to all procedures as defined by the Montreal Protocol's 1998 "Non-compliance procedure". In addition, the lives of 3 million American voters and taxpayers are affected for the worse, and their lives are placed in jeopardy.