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May 6, 1998

Mr. Chairman, Members of the Subcommittee, thank you for the opportunity to testify before you on the important public health goals of assuring that American asthmatics continue to have access to safe and effective medications, and protecting the stratospheric ozone layer. I have been asked to provide the Committee with information on the collaboration between the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) in the safe transition to ozone-safe metered dose inhalers (MDIs), and on many points related to FDA's March 6, 1997 Advance Notice of Proposed Rulemaking (ANPRM). If you remember nothing else from my testimony today, Mr. Chairman, members of the Subcommittee, I hope you will remember these points:

  1. EPA is not taking away asthma inhalers from any asthma sufferer: in fact, we are committed to making sure MDIs using CFC propellants remain available until there are safe, effective and acceptable alternatives for all who need them; and
  2. Because the pharmaceutical industry is developing safe and effective alternatives, we do not have to choose between protecting our children from higher rates of skin cancer caused by ozone depletion and protecting patients -- many of them children -- with asthma. We at EPA are committed to healthy children and a healthy environment, but to healthy children first.

I would like to begin my testimony with a few general observations. As you know, the U.S. in collaboration with many other industrialized countries ceased production of CFCs on January 1, 1996. Remaining production continues pursuant to an "essential use" provision, allowing countries to request additional CFC production in cases where health, safety or national security are at risk because alternatives to a particular CFC-based use do not exist. Since the inception of the essential use process in 1996, the U.S. has forwarded a limited number of requests, including requests for additional production of CFCs for use as propellants in MDIs for some 30 million Americans suffering from asthma and other chronic respiratory diseases.

A strong partnership between the public sector and industry should be credited with the limited number of U.S. essential use requests. This partnership has resulted in tremendous success over the past decade in finding reliable substitutes for CFCs in a wide range of industrial and consumer uses, and has translated into an enormous competitive edge in environmental technologies worldwide. Although scientists do not expect the ozone layer to fully recover until the middle of the next century, researchers at the Department of Commerce's National Oceanic and Atmospheric Administration have already measured declines in concentrations of ozone-depleting compounds, providing early proof of the success of the Montreal Protocol.

Unfortunately, good faith efforts by pharmaceutical manufacturers and government agencies have led to confusion among users of MDIs and in the medical community. Some fear the job of protecting the ozone layer to lower future incidence of skin cancer can only be completed by ignoring the legitimate needs of those who rely on these important medications, in some cases for their lives. I hope to address this confusion in my remarks today, because I believe that the approach already laid out in the Clean Air Act Amendments (CAAA) of 1990 is the right course, both to preserve availability of important therapies for asthma and to protect Americans from skin cancer. These important public health goals are not in competition, but in fact can and must both be achieved. Now I would like to turn to specific questions raised in the Subcommittee's letter of invitation. I have been asked to describe a range of topics relevant to the FDA ANPRM, and in my answers I will confine myself to areas over which EPA has direct authority. Because the ANPRM was not drafted by EPA, my FDA colleague is better positioned to describe its origins, but I will to the best of my ability lay out the broad statutory and legal framework under which EPA and FDA collaborate to protect Americans with asthma and chronic obstructive pulmonary disease (COPD).

In my discussion of legislative authority, I intend to confine my remarks specifically to EPA's statutory and legal framework. There are a number of CAAA provisions relevant to EPA's responsibilities and authority to effectuate a phaseout of CFCs, including those used in MDIs. Section 604, for example, calls for a total phaseout of production of CFCs, but includes a specific exemption for limited quantities of substances for use in medical devices, if such an exemption is consistent with the Montreal Protocol, and if production is determined by FDA, in consultation with EPA, to be necessary. Under the Montreal Protocol, essential use exemptions to manufacture CFCs in medical devices must be approved annually by the Parties to the Montreal Protocol.

As required by section 610 of the CAAA, EPA has issued regulations containing a ban on the sale and distribution of CFCs in pressured dispensers (40 CFR 82.64 (c) and 82.66 (d)). These provisions exempt from the ban "medical devices" that FDA, in consultation with EPA, determines to be essential for which no safe and effective alternatives have been developed and approved, and that are listed in 21 CFR 2.125 (e). Another relevant CAAA provision is section 614(b), which requires that in any case of apparent conflict between the Clean Air Act and the Montreal Protocol, the more stringent of the two regimes be applied. Similarly, section 606 requires EPA to accelerate the control requirements included in the CAAA if the Montreal Protocol is modified to control production, consumption or use of any substance more rapidly than the CAAA. In fact, in 1992, based on new scientific findings demonstrating serious damage to the ozone layer, the Montreal Protocol was modified to require an accelerated phaseout. In accordance with section 606, EPA regulations established January 1996 as the date of the U.S. CFC phaseout.

With reference to the ANPRM, it is our understanding that its purpose was to invite public comment on criteria FDA might use to determine when -- based on the availability of safe and effective alternatives -- CFC-containing MDIs might no longer be considered essential.

I will now describe EPA's interaction with other governmental and nongovernmental entities regarding the ANPRM. As encouraged in the legal framework briefly detailed above, and consistent with the practice of Executive Branch review of policies being developed by agencies, EPA has worked cooperatively to provide support to FDA, particularly on environmental and international aspects, in the development of their ANPRM. Our primary goal in these interactions was to address environmental aspects and help ensure that at an early stage in regulatory development, the fullest possible range of options might be considered.

Thus, in the interagency review process prior to the ANPRM's issuance, EPA combined elements of existing FDA options described as fully protective of patient health and proposed addition of this combined approach, to broaden possible approaches for public stakeholder comment, while retaining patient safety as the primary goal.

The goal of assuring wide debate has been achieved: many commenters have provided FDA with a wealth of fresh perspectives, which will no doubt be vital in FDA's effort to refine or redraft the existing approaches. EPA has attended -- and listened carefully -- at public hearings and conferences at which a wide range of comments were raised, and has heard FDA's general summary of the comments received. Careful attention has allowed EPA's perspective to evolve to the view EPA has expressed in letters and testimony over the past several months. We still believe firmly in a process that encourages investment in a wide range of CFC-free alternatives. However, only when FDA, in consultation with EPA, ultimately makes the necessary medical judgement about the availability of alternatives, so that patient safety is absolutely assured, can any change take place.

I have also been asked to discuss the effect of this ANPRM and subsequent rulemakings on the availability of medications for persons suffering from asthma and other lung conditions. Because an ANPRM represents a very preliminary discussion, and not a final regulatory action, it should not have any effect on the availability of medications, except to the extent it encourages certainty, and thus investment, in the wide range of acceptable alternatives that patient safety will ultimately require. It would be inappropriate for EPA to speculate on the final form FDA action might take, but it is clear that FDA's intention, which we share, is that CFC-propelled inhalers remain available until there are safe and effective alternatives for all who need them.

Finally, the Subcommittee's letter also asked EPA's perspective on legislation that would require the Secretary of Health and Human Services to take no further action with respect to the ANRPM. EPA would not support the withdrawal of FDA's medical expertise and thorough and informed assessment from this process. I believe the responsible course for protecting public health is to put patient protection first, in a course already well-charted in the Clean Air Act Amendments of 1990 (CAAA), which clearly and correctly includes a role for FDA to make needed medical judgements in this process. This bipartisan course aimed at two goals which were not then, and are not now, in competition: to assure the best possible care for those with asthma and other respiratory disease and to prevent skin cancer and other health effects caused by ozone layer depletion.

Abandoning this course now would ignore the need to encourage open and timely continuing action by FDA, the Agency with the medical expertise to effectively achieve patient safety, and to make appropriate decisions about the efficacy of new medications, and the availability of alternatives. It would ignore the disinterested recommendations of a number of leading patient and medical groups, who have consistently not supported legislative intervention. It would be unfair to the pharmaceutical industry, which has invested large sums of money, talent, and effort to develop a world competitive advantage in research on and development of improved and innovative asthma care therapies for the future. Finally, it would undermine the continuing U.S. commitment to forward and successfully defend essential use exemption requests every year additional CFC production is needed, because it would convey not only to pharmaceutical companies but to the world community of Montreal Protocol Parties that the U.S. is not serious about upholding our obligations under the treaty.

I would now like briefly to address several additional relevant issues. Continued damage to the ozone layer is not a theoretical matter of concern to environmentalists, but has real effects on ordinary people. Recent data from the National Cancer Institute and the Centers for Disease Control and Prevention show that while incidence of most cancers has begun to decline, new cases of the most-often fatal form of skin cancer, malignant melanoma, continue to rise. While many genetic and behavioral factors contribute to skin cancer, this upward trend should reinforce our commitment to protect Americans from skin cancer. As we will hear today, another unfortunate public health trend in our country is the rise of asthma. While such information is sobering, it is important to emphasize that the right policy will not choose between these public health concerns, but will both assure effective care for respiratory diseases and lower risk of skin cancer from ozone depletion.

Only when an adequate number of safe, effective and acceptable CFC-free alternatives are available, can we safely ensure the healing of the ozone layer. MDI use is growing, which is appropriate as the incidence of disease is growing. Because health care is a priority worldwide, and standards of living are slowly improving, future standards of care will mean asthmatics in New Delhi and Beijing ultimately will rely on the same dependable therapies that are now being introduced in developed countries. As growth happens, we want to make sure it happens in ways that protect the ozone layer.

It is also important to assure industries that have already made substantial contributions to research and development aimed both at better patient care and environmental protection that they will have achieved for themselves a long-term competitive advantage in better serving the world's growing demand for asthma therapies. Looking at this issue from the perspective of companies trying to decide whether to continue to invest in ozone-safe improved asthma therapies suggests that preventing the development of a medically informed transition strategy by legislation would significantly complicate these decisions. On the other hand, if companies remain confident that the U.S. is moving ahead in a reasoned, medically-based process to identify and make available ample CFC-free alternatives to replace existing therapies, and they know that ultimately this transition will occur, then market forces will take care of setting in motion the needed investment to assure that the alternatives are available when patients need them.

While I would not wish to speculate about any effects any final actions undertaken by the Administration might have, I can reassure the Subcommittee on the present status of development of new CFC-free asthma therapies generally. Industry information submitted to EPA in support of the annual U.S. essential use exemption request demonstrates that, of the more than thirty MDIs now on the market, most are moving ahead at some stage in the process of reformulation. There is already an approved MDI available which supplies albuterol, without relying on CFCs as the propellant to deliver the medication.

The pharmaceutical industry reports that, to date, it has invested over $1 billion to identify safe and effective ways to reformulate CFC-based MDIs so medications can be delivered without damaging the ozone layer. The sheer number of products being reformulated demonstrates industry's commitment. Even taking a conservative view, soon after 2001, we should have additional CFC-free albuterol inhalers on the market. By that time, CFC-free versions of other important MDI-based therapies should be available as well.

To reassure patients that no changes being contemplated would leave them without the medications they need, EPA together with the National Institutes of Health and representatives from industry, the Allergy and Asthma Network/Mothers of Asthmatics, the American Lung Association, the Asthma and Allergy Foundation, and other public health agencies such as the FDA, developed a brochure which I have here and which I would be happy to submit for the record, if there is interest in the Subcommittee. In preparing this brochure, the groups involved agreed on important basic messages and information patients need. EPA is committed to continue working with these groups to correct any misinformation that may exist.

At the international level, I believe all countries of the world share our commitment to fully protect patients. Every year, the Parties to the Montreal Protocol decide to grant requests from each country for additional CFC production. All prior requests that the U.S. has deemed essential have been approved in their entirety based on medical need and our commitment to move forward. We do not anticipate a rejection of any future U.S. request, and clearly the responsible course for protecting the availability of the CFC-based medications still needed by U.S. asthmatics is to create the best-supported U.S. request possible. A crucial element of supporting that request is to continue to plan for the time when CFC-free alternatives are fully available.

The Montreal Protocol imposes no clear due date for the MDI transition on the U.S. or on any country. In 1996, the Technical and Economic Assessment Panel (TEAP), an expert advisory body to the Montreal Protocol Parties, suggested in its evaluation of the progress of transition in different countries that 2005 might be an appropriate date for transition to conclude. Some have suggested that this date should be adopted by the U.S., or that the Montreal Protocol already requires it. However, the TEAP is an advisory body only, and no action has yet been taken by the Parties to set any firm date by which the MDI transition must conclude.

One due date that does exist within the international process is January 31, 1999, although this date relates to information sharing, not to any other milestone for progress. By that date, countries requesting essential uses will share an initial draft plan with the Parties describing their country's strategy for managing the transition. The purpose of this requirement is to assure the Parties that countries continuing to request exemptions consider how best to move forward with a transition, and to facilitate the sharing of ideas and approaches among countries facing this issue. The requirement does not create any international approval process for country-based strategies, nor does it compel a nation to implement any approach described in the initial strategy submitted. The U.S. has already shared the ANPRM with international colleagues informally prior to the decision requiring such submission in 1999. I am confident that the consultation and information sharing already done satisfies this requirement.

By virtue of the draft transition strategy, the U.S. has shown leadership, but we are by no means alone in the process of reformulating important asthma therapies. Other countries are moving forward. IPAC estimates that by 2000 in the European Union (EU), 2 CFC-free albuterol substitutes will be available in each EU member state, compared to the single product approved in the U.S. Some of this more rapid progress by the EU is likely to be reflected in reductions in the amount of CFCs requested by these countries for use in future years.

Misinformation has given rise to a sense of urgency surrounding the ANPRM. Particular confusion surrounds EPA's role. An editorial in the Wall Street Journal summarizes key elements of this confusion, alleging among other things that EPA would "announce a ban on...inhalers" at the Meeting of the Parties to the Montreal Protocol, held in Montreal in September 1997. EPA had no such intention, and no such announcement was made. The editorial further stated that EPA would no longer "ask to exempt inhalers" from the CFC production ban. In fact, at that meeting EPA successfully argued for exemptions to produce CFCs for use in MDIs in the year 1999. I assure the Subcommittee that EPA remains committed to supporting necessary exemptions until there are safe and effective CFC-free medications available for all who need them. Finally, the Journal's editorial asserted that on September 19, 1997, the Clinton Administration proposed to "take away asthma inhalers from...children." No such proposal was issued on that date, or contemplated by the Administration at any time.

The record of EPA's actions speaks very clearly, and in stark contrast to the allegations above. For the past five years, since the inception of the essential use process prior to the U.S. CFC phase out in 1996, EPA has worked with other federal agencies and pharmaceutical manufacturers to compile, substantiate and successfully defend annual essential use requests. Most recently, on January 16, 1998, Administrator Browner signed a final rule allocating "essential use allowances" for specific continued uses of CFCs, including as propellants in MDIs, for the year 1998. This final rule -- and the prior five years' of effort -- demonstrate EPA's tireless effort to assure that CFCs for asthma inhalers can continue to be produced until there are safe and effective alternatives for all who need them.

EPA's perspective remains guided by the need to assure continuing availability of lifesaving medications for asthmatics as we protect the ozone layer. While recovery of the ozone layer is expected, recent scientific data from satellites and balloons reveal unusually low ozone levels in the Arctic, following a pattern previously only seen at the Antarctic ozone hole. At the same time, skin cancer is rising in the U.S. at what the American Academy of Dermatology has called "epidemic" rates. For a child born today, the lifetime risk of skin cancer is much greater than it was twenty years ago. Protecting the ozone layer will reduce that risk, so future generations will be less likely to suffer dangerous and disfiguring skin cancers.

But continuing progress in ozone layer protection cannot come at the expense of other growing public health concerns, like asthma. In contrast to the rumor that a "ban" on inhalers is imminent, the reality is that EPA is committed to protect all MDI users. Over time the availability of substitutes will provide plenty of options for American asthmatics while protecting the ozone layer, so that as we preserve the best possible treatments for asthma, we also lower the incidence of skin cancer.

We must continue our leadership role by meeting our commitments as a Party to the Montreal Protocol, ensuring that we take the responsible road of decreasing skin cancer for our children and future generations, while maintaining the high standard of care the U.S. has always enjoyed for asthma and other respiratory diseases. This is where sound policy leads, and I urge you to support us in this effort.

Thank you, Mr. Chairman, Members of the Subcommittee, for your attention. I would be happy to answer any questions you may have.

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