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[House Report 112-673]
[From the U.S. Government Publishing Office]

112th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     112-673

======================================================================

 
                   ASTHMA INHALERS RELIEF ACT OF 2012

                                _______
                                

 September 14, 2012.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            DISSENTING VIEWS

                        [To accompany H.R. 6190]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 6190) to direct the Administrator of the 
Environmental Protection Agency to allow for the distribution, 
sale, and consumption in the United States of remaining 
inventories of over-the-counter CFC epinephrine inhalers, 
having considered the same, report favorably thereon without 
amendment and recommend that the bill do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     5
Committee Consideration..........................................     5
Committee Votes..................................................     5
Committee Oversight Findings.....................................     5
Statement of General Performance Goals and Objectives............     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Earmark..........................................................     6
Committee Cost Estimate..........................................     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     6
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of Legislation.......................     7
Changes in Existing Law Made by the Bill, as Reported............     7
Dissenting Views.................................................     8

                          PURPOSE AND SUMMARY

    H.R. 6190, the ``Asthma Inhalers Relief Act of 2012,'' was 
introduced by Representative Michael Burgess, M.D. on July 25, 
2012 (together with Representatives Barton, Carter, Matheson, 
Pitts, and Ross). The legislation would direct the 
Administrator of the Environmental Protection Agency (EPA) to 
allow for the distribution, sale, and consumption of remaining 
inventories of chlorofluorocarbon (CFC) epinephrine inhalers. 
These inhalers were banned in the U.S. as of December 31, 2011, 
pursuant to the Montreal Protocol on Substances that Deplete 
the Ozone Layer and Title VI of the Clean Air Act, for the 
purpose of reducing emissions of ozone depleting substances 
into the air.
    Key provisions of this bill would:
           Direct the Administrator of EPA to allow for 
        the distribution, sale, and consumption of remaining 
        inventories of CFC epinephrine inhalers, commonly known 
        as Primatene Mist;
           Direct the Administrator of EPA to refrain 
        from taking any enforcement action against any 
        distributor or seller of such inhalers on the basis of 
        any Federal law implementing the Montreal Protocol; and
           Require the Administrator of EPA to issue a 
        No Action Assurance Letter to any requesting 
        distributor or seller stating that the agency will not 
        initiate such an enforcement action.

                  BACKGROUND AND NEED FOR LEGISLATION

    Epinephrine inhalers containing CFCs, most commonly 
marketed as Primatene Mist, have been sold in the U.S. without 
physician's prescription as an over-the-counter (OTC) medicine 
to provide relief of asthma symptoms for over 40 years. As of 
December 31, 2011, the manufacture and sale of these inhalers 
has been banned for the purpose of reducing emissions of ozone 
depleting substances into the air pursuant to the Montreal 
Protocol on Substances that Deplete the Ozone Layer and Title 
VI of the Clean Air Act. Prior to the ban, the Food and Drug 
Administration (FDA) estimated 1.7 million to 2.3 million 
consumers purchased approximately 4.5 million such inhalers 
annually. There is a remaining inventory of over one million 
such units currently in storage at the manufacturer's facility, 
and the legislation would allow for distribution, sale, and 
consumption of this remaining inventory. The legislation would 
sunset on August 1, 2013.

Statutory and regulatory background

    The Montreal Protocol on Substances that Deplete the Ozone 
Layer (Montreal Protocol) is an international environmental 
treaty designed to reduce emissions of ozone-depleting 
substances into the atmosphere by limiting the production and 
consumption of those substances. CFCs are included among the 
listed ozone-depleting substances. The treaty entered into 
force in 1989, and to implement the treaty, Congress amended 
the Clean Air Act in 1990 to add Title VI which is administered 
and enforced by the EPA.
    Under the treaty and Clean Air Act Title VI, the use of 
CFCs has been phased out in the United States, subject to 
certain exemptions including for essential uses. One of the 
most important essential uses of CFCs has been as a propellant 
to deliver therapeutic medicine into the respiratory system of 
patients who use metered-dose inhalers (MDIs) for the relief of 
respiratory symptoms caused by asthma and chronic obstructive 
pulmonary disease. For decades, OTC CFC epinephrine inhalers 
were exempt from the phaseout of CFCs.
    In 2008, however, the FDA, in consultation with EPA, 
removed the essential-use designation for such inhalers and 
prohibited their sale as of December 31, 2011. In its 
rulemaking, FDA concluded that there are no substantial 
technical barriers to formulating epinephrine as a product that 
does not release ozone-depleting substances. FDA also concluded 
that while the availability of a replacement product was not 
necessary for the agency to remove the essential use 
designation, a December 31, 2011, phaseout date would give 
sufficient time for the development of a non-CFC formulation of 
epinephrine MDIs and the processing of an application for new 
drug approval. FDA also concluded at that time that the costs 
associated with removing OTC epinephrine MDIs from the market 
the rule could range from $180 million to $1.1 billion annually 
measured in 2007 dollars due to increased physician visits, 
more expensive medicines, and increased emergency room visits 
and hospitalizations.

Remaining inventories of Primatene Mist inhalers

    There are currently approximately 1.2 million OTC 
epinephrine inhalers that were not sold or distributed before 
the ban went into effect. On July 18, 2012, Mr. Jason Shandell, 
Vice President and General Counsel of Amphastar 
Pharmaceuticals, Inc., the parent company of Primatene Mist's 
manufacturer, testified that the manufacturer discontinued 
manufacture of the inhalers in August 2011 when the company's 
allocated CFC to produce Primatene Mist was exhausted, has shut 
down its manufacturing facility plant and is currently storing 
this remaining inventory at the company's facilities in 
California. He also testified that the manufacturer has asked 
both EPA and FDA how to dispose of the inventories, but to date 
has not received a response.

Need for legislation

    There is currently no OTC asthma inhaler available to 
patients that require relief from respiratory symptoms caused 
by asthma.\1\ Prior to the ban going into effect, the National 
Association of Chain Drugstores, the National Community 
Pharmacists Association, other distributors, and the 
manufacturer submitted requests to EPA for a waiver to allow 
for the sale or distribution of the remaining inventories 
without threat of an EPA enforcement action.
---------------------------------------------------------------------------
    \1\The Committee is informed that Nephron Pharmaceuticals Corp. 
plans to offer an alternative OTC nebulizer product in retail outlets 
starting in August 2012. Mr. Shandell also testified that an 
alternative OTC epinephrine inhaler without CFCs is under development 
and anticipates submitting an application to FDA in the fourth quarter 
of 2012.
---------------------------------------------------------------------------
    On December 30, 2011, EPA declined the manufacturer's 
request. As a result, patients must now see a doctor to obtain 
a prescription for an alternative inhaler at significantly 
higher cost, estimated to be up to four to five times higher, 
while at the same time remaining stocks of Primatene Mist 
remain in storage. On July 18, 2012, Mr. Shandell testified 
that ``we have received thousands of inquiries from users of 
Primatene Mist who are desperate for availability of an over-
the-counter inhaler.'' He also testified that ``the untreated 
and undertreated asthma patient population is largely comprised 
of uninsured, economically disadvantaged black and Hispanic 
communities. This includes a large number of women and 
children. Without Primatene Mist, those asthmatics who have no 
insurance, they may have to seek care in emergency rooms which 
can take many hours and cost thousands of dollars.''
    On July 18, 2012, Dr. Edward Kerwin, Senior Medical 
Director at the Allergy and Asthma Center of Southern Oregon, 
testified that Primatene Mist is a ``life preserving medicine'' 
for patients who are experiencing a severe asthma attack and do 
not have access to a doctor or hospital. He further testified 
that in rural areas, many patients may live distant from either 
a doctor or an emergency room. He testified that there is no 
longer any OTC rescue-relief medicine available for those 
experiencing an acute asthma attack, and that Primatene Mist 
inhalers play a particularly vital role for low-income asthma 
patients who cannot afford insurance or the price of both a 
doctor's appointment and a prescription inhaler.
    Dr. Kerwin testified that ``Primatene Mist is a first aid 
situation kind of medicine. The reason it is over-the-counter 
is that there need to be immediate access, immediate use 
medicines available to children, poverty-stricken patients, 
elderly people who have acute airway disease.'' He stated ``We 
need regular access to emergency medicines.'' He stated ``I 
live in a rural State. Many patients in southern Oregon live 50 
miles from the nearest doctor. That is quite common. Certainly, 
100 miles from an emergency room. We believe there is a role 
for Primatene or epinephrine or any over-the-counter inhaler.'' 
He also testified that ``even though for 50 years rescue 
epinephrine has been available OTC to every American, now there 
is no rescue inhaler that you can get in rural America, in the 
West, South, Midwest, or Northeast, in inner cities, or for 
poor or elderly patients with poor mobility.''

H.R. 6190--The Asthma Inhalers Relief Act of 2012

    H.R. 6190, the ``Asthma Inhalers Relief Act of 2012,'' 
would direct EPA to allow for the distribution, sale, and 
consumption of the remaining inventories of over-the counter 
CFC epinephrine inhalers without penalty, providing temporary 
relief to asthma patients.
    While the legislation is focused on EPA, the legislation 
expressly provides that FDA will continue to have authority to 
regulate the inhalers to be distributed should there be any 
safety-related concerns. In particular, H.R. 6190 provides that 
the legislation would not in any way limit or otherwise affect 
the authority of FDA to ensure the safety and effectiveness of 
CFC epinephrine inhalers. With respect to the safety of these 
inhalers, FDA's website currently states that these are safe to 
use.\2\
---------------------------------------------------------------------------
    \2\On FDA's website, the agency lists questions and answers 
relating to the Primatene Mist ban. See http://www.fda.gov/Drugs/
DrugSafety/InformationbyDrugClass/ucm080427.htm. In response to the 
question ``Is it safe for epinephrine users to `purchase sufficient' 
amounts of Primatene Mist to use following the phase out date of 
December 31, 2011?'' the website states: ``Epinephrine users can use 
the product after December 31 because the product phase-out only 
applies to the manufacture and sale of the product after December 31.'' 
The website further states that ``[i]f you haven't used up your 
Primatene Mist by Dec. 31, 2011, it's safe to continue using it as long 
as it hasn't expired.''
---------------------------------------------------------------------------
    The legislation would not have any significant adverse 
environmental impact. In its 2008 regulation, FDA stated that 
removing these inhalers would reduce CFC emissions by ``only a 
fraction of 1 percent of total global CFC emissions.'' The 
legislation would also sunset before a separate ban on two 
other prescription inhalers that use CFCs as a propellant takes 
effect in December of 2013.

                                HEARINGS

    On July 18, 2012, the Subcommittee on Energy and Power held 
a legislative hearing on the ``Asthma Inhalers Relief Act of 
2012,'' and received testimony from:
           Jason Shandell, General Counsel & Secretary, 
        Amphastar Pharmaceuticals;
           Edward M. Kerwin, MD, Senior Medical 
        Director, Allergy & Asthma Center of Southern Oregon;
           Monica Kraft, MD, Professor of Medicine, 
        Duke University, President, The American Thoracic 
        Society, Director, Duke Asthma, Allergy and Airway 
        Center;
           Chris Ward, MD, Former Chairman, Board of 
        Directors of the Asthma and Allergy Foundation of 
        America; and
           Regina McCarthy, Assistant Administrator for 
        Air and Radiation, U.S. Environmental Protection Agency 
        (Written Statement for the Record).

                        COMMITTEE CONSIDERATION

    H.R. 6190 was introduced on July 25, 2012, by 
Representatives Michael Burgess, M.D. (together with 
Representatives Barton, Carter, Matheson, Pitts, and Ross).
    On July 18, 2012, the Subcommittee on Energy and Power held 
a legislative hearing on the ``Asthma Inhalers Relief Act of 
2012.''
    On July 18 and 19, 2012, the Subcommittee on Energy and 
Power met in open markup session and favorably reported the 
bill to the full Committee by voice vote. No amendments were 
offered.
    On July 31 and August 1, 2012, the Committee on Energy and 
Commerce met in open markup session. Two amendments were 
offered but defeated by voice vote.
    On August 1, 2012, the Committee ordered H.R. 6190 
favorably reported to the House by voice vote.

                            COMMITTEE VOTES

    Clause 3(b) of rule XII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. A 
motion by Mr. Upton to order H.R. 6190 reported to the House, 
was agreed to by voice vote. There were no requests for 
recorded votes.

                      COMMITTEE OVERSIGHT FINDINGS

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee made findings that are 
reflected in this report.

         STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

    H.R. 6190 directs the Administrator of the Environmental 
Protection Agency to allow for the distribution, sale, and 
consumption in the United States of remaining inventories of 
over-the-counter CFC epinephrine inhalers.

   NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
6190, the ``Asthma Inhalers Relief Act of 2012,'' would result 
in no new or increased budget authority, entitlement authority, 
or tax expenditures or revenues.

                                EARMARKS

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI, 
the Committee finds that H.R. 6190, the ``Asthma Inhalers 
Relief Act of 2012,'' contains no earmarks, limited tax 
benefits, or limited tariff benefits.

                        COMMITTEE COST ESTIMATE

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  CONGRESSIONAL BUDGET OFFICE ESTIMATE

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974.

H.R. 6190--Asthma Inhalers Relief Act of 2012

    H.R. 6190 would direct the Environmental Protection Agency 
(EPA) to allow the distribution, sale, and consumption of the 
remaining inventories of over-the-counter asthma inhalers that 
contain chlorofluorocarbons (CFCs) through August 1, 2013. 
Sales of this type of inhaler have been phased out under the 
Clean Air Act and the Montreal Protocol, an international 
treaty to reduce ozone-depleting substances, such as CFCs. (An 
example of such an inhaler was sold under the brand name, 
Primatene Mist.)
    According to EPA, under this legislation, the agency would 
end enforcement of the ban on the sale and distribution of 
inhalers that contain CFCs, but it would continue to verify 
that such inhalers are not manufactured or imported. CB0 
estimates that implementing this legislation would have no 
significant impact on the federal budget because of the limited 
amount of EPA resources dedicated to those activities. Pay-as-
you-go procedures do not apply to H.R. 6190 because the bill 
would not affect direct spending or revenues.
    This bill contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would impose no costs on state, local, or tribal governments.
    The CBO staff contact for this estimate is Susanne S. 
Mehlman. The estimate was approved by Peter H. Fontaine, 
Assistant Director for Budget Analysis.

                       FEDERAL MANDATES STATEMENT

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      ADVISORY COMMITTEE STATEMENT

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  APPLICABILITY TO LEGISLATIVE BRANCH

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

               SECTION-BY-SECTION ANALYSIS OF LEGISLATION

Section 1--Short title

    Section 1 provides the short title of ``Asthma Inhalers 
Relief Act of 2012.''

Section 2--Distribution, sale, and consumption of remaining inventories 
        of over-the-counter CFC epinephrine inhalers

    Section 2 addresses the distribution, sale, and consumption 
of remaining inventories of over-the counter CFC epinephrine 
inhalers.
    Section 2(a) directs the Administrator of the Environmental 
Protection Agency to allow the distribution, sale, and 
consumption of remaining inventories of such inhalers, refrain 
from taking any enforcement action against any distributor or 
seller on the basis of any Federal law implementing the 
Montreal Protocol, and issue a No Action Assurance Letter to 
any requesting distributor or seller stating the agency will 
not initiate such an enforcement action.
    Section 2(b) clarifies that nothing in the legislation 
should be construed to limit the authority of the Food and Drug 
Administration, under the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.), to ensure the safety and effectiveness 
of such inhalers.
    Section 2(c) provides the following definitions:
        1. ``CFC epinephrine inhaler'' means any epinephrine 
        inhaler containing CFCs that was manufactured and 
        classified as over-the-counter prior to January 2, 
        2012;
        2. ``Federal law implementing the Montreal Protocol'' 
        means any provision of Title VI of the Clean Air Act or 
        other Federal law implementing the Montreal Protocol, 
        including the regulation entitled ``Use of Ozone-
        Depleting Substances; Removal of Essential-Use 
        Designation (Epinephrine)'' published at 73 Fed. Reg. 
        69532 (November 19, 2008);
        3. ``Montreal Protocol'' has the meaning given in 
        section 601 of the Clean Air Act.; and
        4. ``Over-the-counter'' means not subject to section 
        503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.SC. 353(b)(1)) or otherwise not required to be 
        dispensed only upon issuance of a prescription.
    Section 2(d) provides that the Act shall cease to be 
effective on August 1, 2013.

         CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

    The bill does not change existing law.

                            DISSENTING VIEWS

    The Montreal Protocol, signed in 1987, is widely recognized 
as a tremendously successful international environmental 
agreement that has dramatically reduced the production and use 
of substances that deplete the stratospheric ozone layer, such 
as chlorofluorocarbons (CFCs). The Environmental Protection 
Agency (EPA) regulations implementing the Montreal Protocol 
prohibit the production and import of CFCs with an exception 
for essential metered dose inhalers (MDIs). Under the Clean Air 
Act and its implementing regulations, the Food and Drug 
Administration (FDA) determines whether a MDI is essential.
    On November 19, 2008, FDA issued a final rule removing the 
essential use designation for epinephrine MDIs containing CFCs. 
FDA concluded that there are no substantial technical barriers 
to formulating epinephrine as a product that does not release 
ozone-depleting substances. At that time, the only remaining 
CFC-containing epinephrine MDI on the market was Primatene 
Mist. As requested by Armstrong, the manufacturer of Primatene 
Mist, FDA set a phase-out date of December 31, 2011, one year 
longer than was originally proposed in 2007. Primatene Mist was 
phased-out on December 31, 2011, and it has not been on the 
market for the past eight months.
    Prior to its phase-out, Primatene Mist was the only 
epinephrine metered dose inhaler available over-the-counter 
without a prescription. According to Armstrong, the company has 
between 1.2 million and 1.5 million units of Primatene Mist 
left in its inventory with a potential market value of between 
$15 million and $18 million.\1\
---------------------------------------------------------------------------
    \1\Letter from Jason Shandell, Vice President and General Counsel, 
Amphastar Pharmaceuticals, Inc., to Rep. Henry A. Waxman (Jul. 16, 
2012).
---------------------------------------------------------------------------
    The bill directs the Administrator of the EPA to allow for 
the distribution, sale, and consumption in the United States of 
remaining inventories of over-the-counter epinephrine inhalers 
containing CFCs manufactured pursuant to essential use 
exemptions. The term ``remaining inventories'' is not defined. 
The bill also prohibits EPA from taking any enforcement action 
or otherwise seeking to restrict the distribution, sale, or 
consumption of such inhalers pursuant to the Clean Air Act or 
any other federal law implementing the Montreal Protocol. In 
response to any request by a distributor or seller of Primatene 
Mist, the bill would require EPA to issue a letter to the 
requesting party stating that EPA will not initiate an 
enforcement action relating to the distribution or sale of any 
such inhaler prior to August 1, 2013. Under the bill, these 
provisions would cease to be effective on August 1, 2013.
    The bill's approach raises a number of significant 
concerns.
    First, the bill would overturn an established regulatory 
framework in order to allow a single manufacturer to sell off 
its remaining inventory of the CFC-containing inhaler Primatene 
Mist. FDA has established a clear and open process for 
determining whether inhalers containing CFCs are essential. 
Over the years, more than a dozen types of inhalers containing 
CFCs have been phased-out under this process. The schedules 
were never changed for these thirteen inhalers, and none of 
these other manufacturers were allowed to sell off their 
inventories after the phase-out date. All of these CFC inhalers 
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.
    Even though Armstrong was not singled out by the FDA 
process or required to do anything that other companies were 
not required to do, the bill would change the rules so that 
Armstrong could sell off its inventory of Primatene Mist. The 
bill would directly benefit just one company--Armstrong, the 
maker of Primatene Mist. For example, the bill could benefit 
Armstrong by allowing the company to maintain its market share 
until it can obtain FDA approval for a CFC-free epinephrine 
inhaler.
    Companies that made the necessary investments to develop 
CFC-free inhalers contend that the bill would unfairly provide 
special treatment to a single company. The International 
Pharmaceutical Aerosol Consortium (IPAC), a group of MDI 
manufacturers, argues: ``Granting extraordinary, unwarranted 
and special treatment to a single company would send an 
extremely negative signal to the manufacturers that responded 
to the US Government's call many years ago to be a partner in 
meeting the Montreal Protocol commitments.''\2\
---------------------------------------------------------------------------
    \2\International Pharmaceutical Aerosol Consortium, Re-introducing 
CFC-Based Epinephrine (Primatene Mist) in the United States Is 
Counterproductive to Patient Health and US Policy (July 2012) (fact 
sheet).
---------------------------------------------------------------------------
    On July 26, 2012, FDA officials briefed Committee members 
and staff about the phase-out of Primatene Mist. They also 
raised concerns about overturning FDA's established regulatory 
process for setting deadlines for the phase-out of inhalers 
containing CFCs.
    Second, the Committee heard testimony and received 
additional information from a host of medical organizations 
that putting Primatene Mist back on the market would not be in 
the interests of patients. At a July 18, 2012, legislative 
hearing, Dr. Monica Kraft, a professor of medicine at Duke 
University and President of the American Thoracic Society, 
testified that ``[i]nhaled epinephrine is not a safe drug for 
the treatment of asthma.''\3\ She explained that Primatene Mist 
can ``cause a significantly increased heart rate,'' which ``can 
lead to cardiac stress and heart attacks in older patients or 
patients with heart disease.'' According to Dr. Kraft, the 
American Medical Association twice ``encouraged FDA to consider 
removing inhaled epinephrine from the market.'' She also 
testified that ``[n]o current clinical practice guideline for 
the diagnosis and treatment of asthma recommends the use of 
epinephrine.'' Dr. Kraft expressed concern that ``[p]utting 
Primatene Mist back on the market--for an indefinite period of 
time--will send a very confusing message to patients.'' She 
explained that many people who suffer from asthma have already 
transitioned to other, more effective treatments. Chris Ward, 
who testified on behalf of the Asthma and Allergy Foundation of 
America, echoed this concern, stating: ``Lifting the ban now 
will lead to confusion.''\4\
---------------------------------------------------------------------------
    \3\Dr. Monica Kraft, President of the American Thoracic Society, 
Committee on Energy and Commerce Subcommittee on Energy and Power, 
Legislative Hearing on H.R. _, the U.S. Agricultural Sector Relief Act 
of 2012, and H.R. _, the Asthma Inhalers Relief Act of 2012, 112th 
Cong. (Jul. 18, 2012).
    \4\Chris Ward, Asthma and Allergy Foundation of America, Committee 
on Energy and Commerce Subcommittee on Energy and Power, Legislative 
Hearing on H.R. _, the U.S. Agricultural Sector Relief Act of 2012, and 
H.R. _, the Asthma Inhalers Relief Act of 2012, 112th Cong. (Jul. 18, 
2012).
---------------------------------------------------------------------------
    On July 30, 2012, the American Lung Association, the 
American Thoracic Society, the American Academy of Pediatrics, 
the Asthma and Allergy Foundation of America, and other public 
health groups wrote to Committee members to oppose the 
legislation, stating: ``Our organizations strongly believe that 
allowing this product to return to the marketplace is not in 
the best interests of patients with asthma or public 
health.''\5\ These organizations agreed with Dr. Kraft that 
Primatene Mist is not recommended or considered safe for the 
treatment of asthma because of the potential of epinephrine to 
cause excessive heart stimulation.
---------------------------------------------------------------------------
    \5\Letter from Alpha-1 Association, Alpha-1 Foundation, American 
Academy of Allergy Asthma and Immunology, American Academy of 
Pediatrics, American Association for Respiratory Care, American College 
of Allergy Asthma and Immunology, American Lung Association, American 
Thoracic Society, Asthma and Allergy Network/Mothers of Asthmatics, 
Asthma and Allergy Foundation of America, COPD Foundation, National 
Association for the Medical Direction of Respiratory Care, and National 
Home Oxygen Patients Association to Rep. Ed Whitfield and Rep. Bobby 
Rush (July 30, 2012).
---------------------------------------------------------------------------
    At the July 26, 2012, briefing for members and staff, FDA 
officials explained that Primatene Mist was determined to meet 
the regulatory definition of ``safe and effective'' in 1967, 
but the standard of care for asthma has changed considerably 
over the past 50 years. As a result, physicians and expert 
guidelines do not recommend Primatene Mist for the treatment of 
asthma. The FDA officials also raised concerns about patients 
being confused by the temporary re-introduction of a product 
that has been off the shelves for eight months.
    In anticipation of the December 31, 2011, phase-out of 
Primatene Mist, EPA and FDA took a number of actions to inform 
consumers of the approaching transition. In addition to public 
and stakeholder meetings convened by the agencies, FDA approved 
a message for Primatene Mist cartons and containers indicating 
to consumers that Primatene Mist would not be available after 
December 31, 2011. Under the bill, after being off the market 
for over eight months, Primatene Mist would go back on the 
market, but only for as long as the inventory lasted. Then it 
would once again disappear from the shelves.
    To address concerns about patient confusion and safety, 
Rep. Pallone offered an amendment at the full Committee markup 
of the bill. The amendment would have prevented the provisions 
of the bill from taking effect unless FDA finds that the 
temporary reintroduction of Primatene Mist is unlikely to cause 
significant patient confusion and will provide an overall 
public health benefit. The amendment required FDA to make a 
determination within 30 days. The amendment was defeated by 
voice vote.
    Third, despite concerns from the proponents of the bill 
that no over-the-counter asthma inhalation treatment has been 
available since the phase-out of Primatene Mist, an alternative 
is now entering the market. On July 19, 2012, at the 
Subcommittee markup of this legislation, it was revealed that 
Nephron, a company in Florida, has developed a hand-held, 
battery-operated atomizer that uses vials of a variant of 
epinephrine (racepinephrine hydrochloride).\6\ The product is a 
portable, over-the-counter device and is explicitly being 
marketed as an affordable alternative to Primatene Mist. 
According to Nephron, the product, called Asthmanefrin, will 
soon be available nation-wide at Walmart, CVS, and other retail 
outlets.\7\ Under a 1986 FDA rulemaking, simple epinephrine 
delivery mechanisms like nebulizers or atomizers can be placed 
on the market without pre-approval by FDA.
---------------------------------------------------------------------------
    \6\Letter from Lou Kennedy, Chief Executive Officer of Nephron 
Pharmaceuticals Corporation, to Rep. Kathy Castor (Jul. 17, 2012).
    \7\Nephron Pharmaceuticals Corporation, Nephron Announces 
Asthmanefrin, an Alternatives to Primatene Mist (Aug. 20, 2012).
---------------------------------------------------------------------------
    Nephron made a significant investment to bring this product 
to market, relying on the established regulatory regime. The 
bill's intervention in the market would affect companies that 
have followed the rules and made investments based on those 
rules.
    To avoid picking winners and losers, Rep. Castor offered an 
amendment at the full Committee markup of the bill. The 
amendment would have prevented the provisions of the bill from 
taking effect if an alternative over-the-counter inhalation 
asthma treatment is available on the date of enactment. The 
amendment was defeated by voice vote.
    Finally, it is unlikely that the bill would result in the 
widespread availability of Primatene Mist sought by proponents 
of the legislation. According to Armstrong, 2-3 million people 
used Primatene Mist, but fewer than 1.5 million Primatene Mist 
inhalers remain in Armstrong's inventory. As a result, as many 
as half of all previous users of Primatene Mist would not be 
able to obtain even one inhaler if Armstrong was allowed to 
sell off its remaining inventory. It is unclear whether 
Primatene Mist would be available nationwide and which 
pharmacies or drug stores would carry it. Some retailers may 
opt not to sell inventoried units of Primatene Mist because 
``Armstrong's inventory of Primatene Mist will expire at 
varying times between January and August of 2013.''\8\ 
Additionally, the inventory would not immediately be available. 
According to Armstrong, the company would need to move the 
inventoried units to a subsidiary in order to re-label the 
units to eliminate the labeling statement that Primatene Mist 
would not be available after December 31, 2011.\9\ Thus, 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, as the bill's proponents 
contend.
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    \8\Letter from Jason Shandell, Vice President and General Counsel, 
Amphastar Pharmaceuticals, Inc., to Rep. Henry A. Waxman (Jul. 16, 
2012).
    \9\Id.
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    For the reasons stated above, we dissent from the views 
contained in the Committee's report.
                                   Henry A. Waxman
                                   Bobby L. Rush
                                   Frank Pallone, Jr.

                                  

```