[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.
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\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.
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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\
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\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.''
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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\
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\1\Letter from Jason Shandell, Vice President and General Counsel,
Amphastar Pharmaceuticals, Inc., to Rep. Henry A. Waxman (Jul. 16,
2012).
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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\
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\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).
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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\
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\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).
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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.
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\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).
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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.
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\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).
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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.