[Congressional Record Volume 158, Number 160 (Wednesday, December 12, 2012)]
[House]
[Pages H6724-H6728]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ASTHMA INHALERS RELIEF ACT OF 2012
Mr. BURGESS. Mr. Speaker, I move to suspend the rules and pass 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.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 6190
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Asthma Inhalers Relief Act
of 2012''.
SEC. 2. DISTRIBUTION, SALE, AND CONSUMPTION OF REMAINING
INVENTORIES OF OVER-THE-COUNTER CFC EPINEPHRINE
INHALERS.
(a) In General.--The Administrator of the Environmental
Protection Agency--
(1) shall allow for the distribution, sale, and consumption
in the United States of remaining inventories of CFC
epinephrine inhalers manufactured pursuant to the exception
for medical devices under section 604(d)(2) of the Clean Air
Act (42 U.S.C. 7671c(d)(2));
(2) shall not take any enforcement action or otherwise seek
to restrict the distribution, sale, or consumption of such
inhalers on the basis of any Federal law implementing the
Montreal Protocol; and
(3) shall, in response to any request of any distributor or
seller of such inhalers, including any such request pending
on the date of the enactment of this Act, issue a No Action
Assurance Letter to the requesting party stating that the
Environmental Protection Agency will not initiate an
enforcement action relating to the distribution or sale of
any such inhaler occurring prior to August 1, 2013.
(b) Rule of Construction.--Nothing in this Act shall be
construed to limit or otherwise affect 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 CFC epinephrine inhalers to be
distributed, sold, or consumed pursuant to this Act.
(c) Definitions.--In this Act:
(1) The term ``CFC epinephrine inhaler'' means any
epinephrine inhaler containing chlorofluorocarbons that was
manufactured and classified as over-the-counter before
January 1, 2012.
(2) The phrase ``Federal law implementing the Montreal
Protocol''--
(A) means any provision of title VI of the Clean Air Act
(42 U.S.C. 7671 et seq.) or other Federal law implementing
the Montreal Protocol; and
(B) includes the final rule published by the Food and Drug
Administration entitled ``Use of Ozone-Depleting Substances;
Removal of Essential-Use Designation (Epinephrine)''
published in the Federal Register at 73 Federal Register
69532 (November 19, 2008).
(3) The term ``Montreal Protocol'' has the meaning given
such term in section 601 of the Clean Air Act (42 U.S.C.
7671).
(4) The term ``over-the-counter'' means not subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)) or otherwise required pursuant to
Federal law to be dispensed only upon issuance of a
prescription.
(d) Sunset.--This section ceases to be effective August 1,
2013.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Texas (Mr. Burgess) and the gentleman from California (Mr. Waxman) each
will control 20 minutes.
The Chair recognizes the gentleman from Texas.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on this bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection?
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
H.R. 6190, this is a bill that I honestly wish we did not have to
consider today.
Over the past several years, I have repeatedly asked the Food and
Drug Administration, the Environmental Protection Agency, and even the
White House, the President himself, for answers to questions that I and
other members of the committee have as to why the administration has
refused to grant a waiver to sell the existing stock of over-the-
counter epinephrine inhalers. Only last summer, and because the
committee was moving legislation at the time, did the Food and Drug
Administration finally provide at least some sort of response, albeit
one that was entirely unsatisfactory.
Under the rules known as the Montreal Protocol, certain chemical
propellants used in a number of medical and cosmetic devices were to be
phased out over a number of years, the chlorofluorocarbons, CFC, used
in the epinephrine inhalers. Here is one of the ones that was one of
those propellants. One of the manufacturers of these over-the-counter
inhalers has worked on a replacement inhaler only to meet with
stonewalling through the Food and Drug Administration and requests for
more studies into the device. Although the Food and Drug Administration
claims they are awaiting an application from the company, the company
counters that the Food and Drug Administration once again continues to
move the goalpost. Regardless of the finger-pointing, Mr. Speaker--and
there is much of it surrounding this issue--the fact remains that there
is no viable alternative for the over-the-counter purchase by an
asthmatic suffering from an acute emergency attack.
We've heard that a company is about to market a device, and indeed
there is a device available without a prescription, but it's behind the
counter. In other words, if the pharmacy is open but the pharmacist is
not there, you cannot purchase this device. I know this firsthand
because it happened to me one evening while we were home on one of the
district work periods. The new product uses a nebulizer rather than a
propellant. It's a little more complicated. In my experience, it's a
little more difficult to use and less effective. Nevertheless, it is
available, but the cost differential is significant
[[Page H6725]]
when compared with the old over-the-counter CFC propellant epinephrine
inhaler.
The committee and the Congress should be on the side of putting more
available products into the hands of patients and allowing them to
effectively manage their medical issues. Instead, opponents of this
legislation hide behind false claims of the safety and efficacy of
epinephrine.
Mr. Speaker, I would point out that I've been an asthmatic my entire
life. I have utilized rescue inhalers for a long time. Racemic
epinephrine, the active pharmaceutical ingredient in an over-the-
counter asthma inhaler, has been around for 60 years. There has not
been a question of its safety and efficacy. If so, we know the FDA has
the power to remove a drug or device that they think is unsafe or not
effective. They have given their stamp of approval to racemic
epinephrine again and again over the last 60 years. There continue to
be dozens of epinephrine-based treatments for asthma-related issues
that are used by doctors and medical professionals. Although opponents
of this legislation will claim that they're opposed to the bill because
epinephrine is not safe, this claim is simply not true.
There are currently over 1 million units of these inhalers sitting in
a warehouse in California not helping patients currently suffering from
an asthma attack, not available for a rescue treatment for someone who
cannot get their breath. It's unconscionable to allow them to sit and
gather dust when they could be used to provide relief to America's
asthmatic patients. Moreover, the company is committed to donating any
proceeds from the sale to charity to remove any possible profit motive
from their request to sell these products.
This is not about allowing a company to continue to sell their
product; it's about not allowing a regulatory agency to unreasonably
restrict the access of America's asthmatics to a useful product. I wish
more companies would come forward with a viable over-the-counter asthma
inhaler so that asthmatics could have more and more choices instead of
that costly emergency room visit at 2 a.m.
This bill is about allowing asthmatics to continue to get relief
during an asthma attack, to continue to have an emergency rescue
inhaler available when they deem that they need it, not when the
Administrator of the EPA says they need it or not when the
Administrator of the FDA says they need it.
Members of Congress spend a lot of time talking about how much they
care about the plight of patients--and asthmatics in particular--and
decrying the high cost of health care. Even if it is just for a limited
time, this bill returns a safe, effective, and inexpensive treatment
into the hands of patients suffering from asthma, one that has been in
use for decades.
For me, at least, the issue is clear. Let's side with patients on
this issue. Let's stop this senseless war on asthmatics the
administration has waged for the last 3 years.
With that, I'll reserve the balance of my time.
{time} 1400
Mr. WAXMAN. Mr. Speaker, I yield 4 minutes to the ranking member of
the Health Subcommittee of Energy and Commerce, the gentleman from New
Jersey (Mr. Pallone).
Mr. PALLONE. I thank my colleague, the ranking member from California
(Mr. Waxman).
Congress gave the FDA the responsibility of deciding whether specific
types of inhalers containing ozone-depleting substances are essential
uses and need to remain on the market, and the FDA has established an
orderly and open process for making these determinations: 13 types of
inhalers containing CFCs 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.
The FDA determined in 2008 that Primatene Mist was not an essential
use. They concluded that there are no substantial technical barriers to
developing epinephrine inhalers that do not release ozone-depleting
substances. At the request of Armstrong, the manufacturer of Primatene
Mist, the FDA set a phase-out date of December 31, 2011, which was 1
year longer than the FDA initially proposed. The FDA took steps to
prepare the public for the phase-out. It approved a label for Primatene
Mist which indicated to consumers that Primatene Mist would not be
available after December 31, 2011, and Primatene Mist was phased out on
that date. It has not been available for the past 11 months.
This bill would intervene to put Primatene Mist back on the market.
It is a legislative earmark that directly benefits just one company--
Armstrong. A long list of public health groups, physician
organizations, and patient advocates oppose this bill. They do not
believe that returning Primatene Mist to the market is in the best
interest of patients with asthma or in the best interest of public
health. The following organizations, Mr. Speaker, that oppose this bill
wrote to Members of the House: the American Lung Association, the
American Thoracic Society, the American Academy of Pediatrics, the
Asthma and Allergy Foundation of America, Mothers of Asthmatics.
I could go on. There are eight other public health organizations on
this one letter alone, and I am not aware of any public health
organization that supports this bill. When FDA officials briefed
Members, they expressed many of the same concerns about patient
confusion and of Primatene Mist no longer being the standard of care
for asthma patients.
Now, let's be clear, Mr. Speaker. Every public health group and
patient advocacy group that has looked at this bill has concluded it is
a bad idea. Congress shouldn't be overriding FDA's established
regulatory process if doing so would pose significant patient confusion
and undermine public health. That's just common sense.
Even if we pass this bill, it would not lead to the widespread
availability of Primatene Mist that is sought by the proponents of the
legislation. According to Armstrong, between 2 million and 3 million
people used Primatene Mist before the phase-out, but fewer than 1.5
million Primatene Mist inhalers remain in Armstrong's inventory. That
means that as many as half of all previous users of Primatene Mist
would not be able to obtain even one inhaler if Armstrong were allowed
to sell off its remaining inventory, and it assumes that pharmacies or
drug stores would even carry it. Retailers may decide not to sell
inventoried units of Primatene Mist because the units will start to
expire in January, and that's only a few weeks from now.
So 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.
Mr. Speaker, I don't know what else I can say. This is a bad bill,
and I urge my colleagues to oppose it.
Mr. BURGESS. I yield myself 1 minute.
I would point out that the FDA has not retracted the use of racemic
epinephrine for the short-term use of a rescue inhaler in the treatment
of an acute asthmatic attack. That just simply has not happened. Then
to say that Congress is now seeking to overrule the FDA is preposterous
because those are not the facts on the table right now.
A regulatory earmark? Come on, give me a break. I would welcome other
companies into the marketplace that wanted to create a low-cost,
effective, convenient treatment for asthmatics who need acute
respiratory relief when their standard meds, when their meds that they
take on a chronic basis, either are not working or when, for whatever
reason, a flare-up has occurred.
Look, I'm an asthma patient--I'm on asthma medicine--but in the
product information provided to patients on the long-term medicine is a
statement that this is not intended as a rescue device for an acute
attack. For that, you need something that was previously available over
the counter. I've got to tell you that I was astounded by the elitism
by the EPA at the table in front of us when they told us that they know
better than America's asthma patients. Come on. This is the land of
liberty. Let's give patients the devices they need to manage their
illnesses.
I reserve the balance of my time.
Mr. WAXMAN. Madam Speaker, I yield myself such time as I may consume.
My colleagues, this is a bill that is special for one company in
order for it
[[Page H6726]]
to sell off the batches of the Primatene Mist that it has on stock.
This is a product that's not on the market now--it was taken off the
market--and there are substitutes on the market that the public health
and medical groups say are far better and are far safer.
There are a large number of organizations that have come to the floor
on this bill to oppose it. The Energy and Commerce Committee heard
expert medical testimony that Primatene Mist is not safe or recommended
for treating asthma, and we have a chart here. These are the groups
that oppose this bill and that would urge you to vote ``no'': the
American Lung Association, the American Thoracic Society, the American
Academy of Pediatrics, the Asthma and Allergy Foundation of America.
All of the people involved in health are saying they don't want this
drug on the market, that it will only confuse asthma patients, and that
it is not the safest drug that they could have.
Now, the gentleman from Texas has said what we ought to do if it's
not safe is to take it off the market. It is off the market. It hasn't
been taken off because of safety, but it is not recommended by the
medical community.
There is another group here called the Alliance for Responsible
Atmospheric Policy, and I'd like to indicate some of the organizations
that are part of that alliance, which are some of the major
corporations in this country.
Lastly, I want to show a chart of those who are in favor of this
bill: Armstrong Pharmaceuticals. It is the one company that will
benefit from this bill because it will be able to sell off the reserves
of its product.
Now, is that in the best interest of the patients? Is that what
Congress ought to be doing, passing a special earmarked bill to favor
one company in order for it to be able to take the rest of its stock
and sell it to people?
We do have a Food and Drug Administration, and we do have an
Environmental Protection Agency. We've delegated to them the
responsibility to protect the public health, to make sure that drugs
are safe and effective. This Primatene Mist was supposed to come off
the market, and it was given an additional year. Other companies were
also going to have to go off the market. They knew that, and they're
not on the market now. So why should we take one company's drug and put
it back on the market so that it could sell off the products that it
still has in its backlog?
In fact, as you might imagine, those companies are against this bill.
They say it would overturn an established regulatory framework to
directly benefit just one company--Armstrong. Over the years, more than
a dozen types of inhalers containing CFCs have been phased out, but
these companies say: Why should we do something special for only one
company? We're talking about not just the health groups, but drug
companies like AstraZeneca and GlaxoSmithKline. They oppose this bill
because it provides one company with the special treatment that none of
these other companies receive.
There is no reason for this bill. This is a drug that is already off
the market. There are substitutes that are being developed, and there
are substitutes that are already on the market. I don't think we ought
to be using the Suspension Calendar, of all procedures, to give a
special deal to just one company.
I urge Members to oppose the bill, and I reserve the balance of my
time.
{time} 1410
Mr. BURGESS. I yield myself 1 minute.
The ranking member spoke of a group called the Alliance for Sensible
Atmospheric Policy. I wish this were sensible, Madam Speaker. This is
the most nonsensical thing I have ever encountered. Look, America's
asthma patients are not blowing a hole in the ozone above Antarctica. I
get the fact that Mr. Waxman and I have to give up our hair spray. I
get that. Too much CFCs. You've got it.
I get the fact that our underarm deodorant had too many CFCs and we
had to have a different propellant. But we're talking about an
effective treatment for a very vulnerable group of patients--2 o'clock
in the morning, someone who has asthma who might have run out of their
medicine, or maybe they encountered something that caused their airways
to react, what choice do they now have? They go to the emergency room,
spend $1,500 for a breathing treatment.
This is not something that was held behind the counter by the
pharmacist. This was out on the open shelf available to anyone at any
hour of the day or night. Asthma patients need access to this type of
medication. I would welcome the fact that other companies would want to
create a low-cost, available product for asthmatics to use as a rescue
inhaler.
I reserve the balance of my time.
Mr. WAXMAN. First of all, I want to address some of these issues
myself, and then I will yield to others who want to speak.
There is an environmental problem along with this medical problem.
The environmental problem is that there is a deterioration of the upper
ozone layer. And the United States, under President George H.W. Bush,
negotiated an international treaty called the Montreal Protocol to get
those products off the market that add chlorofluorocarbons which cause
this environmental damage.
And so my friend from Texas is right: we can't get hair spray or
deodorant that has the propellent that has been taken off the market.
But no one's arguing we should let them come back on the market to sell
off their products. There are substitutes. My hair is in place because
I don't need those products any longer. And my friend from Texas is
handling his deodorant problem adequately. The fact of the matter is
there are other products for asthma that the people in the medical
professions say is superior; and they say that Primatene Mist can lead
to damage and become a threat to health. So why are we going to take
this one drug and put it back on the market?
With those comments, I now yield 3 minutes to my good friend from the
State of Michigan (Mr. Dingell), the dean of the House.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Madam Speaker, I thank my good friend for yielding me
this time. Neither he nor I need hair spray, and so we can approach
that matter with some serenity. But I want to say here, I yield to no
one in this Chamber over what has been done or what I have done on food
and drug safety for the American consuming public. I'm the author of
the provisions that require Food and Drug to only market those things
which are safe and effective. If Food and Drug doesn't like this, they
can take it off the market on that ground. They have not chosen to do
so. The only reason it is going off the market is because of the fact
that it bothers the folks who want the Montreal Protocol to go into
place.
Now, let's take a little bit of a look at it. There are 1.2 million
issues of this particular pharmaceutical. A piddling amount of CFCs is
going to be released in that these inhalers are very small. They have a
few milliliters of propellent. It's not going to make any significant
difference. Food and Drug can take it off the market. It is safe. It is
efficacious.
Now I want to talk about a couple of other things. The gentleman from
Texas has talked about what happens when you have these problem as an
asthmatic. My old dad was a former tubercular. He lived through his
life with about half a lung, and I listened to him every night, up
walking around, gasping like a fish on a rock because he couldn't get
air.
There are a lot of people who have used Primatene Mist because they
thought it worked. And if that is so, in fact it does work because it
gives relief to people who are sick. If it is bad, Food and Drug can
take it off the market because it is unsafe. That is not the reason it
is off the market; it is the Montreal Protocol.
Let us consider the fact that there are people out there who need
this substance. Now, I hear that it is going to benefit one company,
the current manufacturer. That manufacturer is not going to make 10
cents on this deal, and the reason is very simple: the profits and the
benefits that are going to be generated by these sales of Primatene
Mist are going to go--guess where--to charity. That's where they're
going.
Who we are helping is the people who have need of this; and if you
haven't
[[Page H6727]]
had a situation where you couldn't get your breath, you don't know the
terrors that exist there. And you don't know the kind of terrors that
my old dad had when I listened to him walking up and down at night,
every night, gasping to get a breath of air. There was no Primatene
Mist in those days, and so there was no relief for him.
Now, they say, well, you can go to the emergency room or somebody's
going to develop relief, but there's nothing on the market that matches
the price. Some of these things that they have that they are saying are
going to be available are possibly going to be available in a little
bit--possibly not. And they also are big, so big that they're not going
to be readily available to somebody who has need. They might be helpful
if they can put them on wheels so that the fellow can tow them around
behind him. But the hard fact of the matter is that Primatene Mist is
going to be there when it is needed, and it is going to provide the
people who want their free choice to have that particular medication.
It will be available to them.
I say make it available to the people. There's no rascality. This is
a safe substance. If it weren't, Food and Drug wouldn't have taken it
off the market because it was either unsafe or inefficacious.
So having said those things, let us support the bill. It's a good
bill. The opposition of other manufacturers is to be expected. They
simply want to cut a fat hog by making profits by selling their
competitive devices.
Mr. BURGESS. I yield myself 1 minute.
The dean of the House described the amount of CFC released into the
atmosphere as a ``piddling'' amount. Actually, the Food and Drug
Administration has quantitated ``piddling'' for us in the Federal
Register of November 19, 2008. They describe that as less than 0.1
percent of the total 1986 global production of CFCs. For the purpose of
edification of the body, I did want to provide that information as to a
definition of piddling.
I reserve the balance of my time.
Mr. WAXMAN. Madam Speaker, I'm pleased now to yield 5 minutes to the
gentlewoman from Florida (Ms. Castor), an important member of the
Energy and Commerce Committee.
Ms. CASTOR of Florida. I thank the ranking member for yielding me
this time.
Madam Speaker, there are a number of reasons why H.R. 6190 is poor
public policy, but I'd like to focus on just one, and that is the
unfair advantage that this bill will grant to a single business to the
detriment of other businesses and manufacturers. And, in fact, the
Congress has received a letter from the International Pharmaceutical
Aerosol Consortium:
On behalf of the International Pharmaceutical Aerosol
Consortium--an association of companies that manufacture
medicines for the treatment of respiratory illnesses, such as
asthma and chronic obstructive pulmonary disease--I am
writing to you today in opposition to H.R. 6190.
IPAC's members include AstraZeneca, GlaxoSmithKline, and a
number of other manufacturers. They say that they strongly
oppose efforts within the House of Representatives to lift
the December 31, 2011, ban on the sale of CFC-based
epinephrine Primatene Mist because such drastic reversal in
settled law will be, one, unnecessary to protect the public
health of asthma patients; and, two, it's contrary to the
United States' important and long-standing commitment to
international treaties.
They point out that this has been ongoing for two decades. The
companies involved in international manufacture, national
manufacturers, have known about this for a long time. They say the only
possible beneficiary of a reversal of the ban on Primatene Mist would
be its manufacturer, which stands to garner a financial windfall if its
limited stocks are sold. Granting extraordinary, unwarranted special
treatment to a single company would send an extremely negative signal
to manufacturers that responded to the U.S. Government's call many
years ago to be a partner in meeting our commitment. Similar prior
requests for deadline relief have been firmly denied by all of the
relevant agencies.
{time} 1420
Now, here's the problem: I was contacted by a Florida company some
months ago. Part of the early rationale for this bill was there was no
alternative. But this Florida manufacturer that played by the rules
called me up. They said, We hear about this hearing on Capitol Hill. Do
you know that we are manufacturing an alternative to Primatene Mist
that will be over-the-counter and that will be affordable?
Nephron Pharmaceuticals has developed such a product, Asthmanefrin, a
handheld, battery-operated device that will allow asthma patients to
inhale a drug similar to epinephrine in Primatene Mist. It is readily
available at Walmart, CVS, Walgreens, Drugstore.com, Walgreens.com,
CVS.com. It's also accessible through McKesson Drug, a national
wholesaler; Smith Drug, a wholesaler covering the Southeast; and
OptiSource. They are doing a national TV campaign now. They have
starter kits. This is available. So that rationale, that early
rationale that there is no alternative does not exist anymore.
But here's the important point: We can't have the Congress granting
an advantage to a single company to the disadvantage of other companies
that have played by the rules. This bill would seriously undermine the
investment decisions of innovative companies like Nephron that have
developed alternatives and solutions to short-term asthma relief.
Congress should not pick winners and losers.
Colleagues, we repeatedly heard the rationale for this bill: there
was no alternative. That rationale is incorrect. It's inaccurate.
Congress should not pull the rug out from under companies that have
followed the rules and expect regulatory certainty in order to benefit
another single company.
I urge you to vote ``no'' on H.R. 6190.
Mr. BURGESS. Madam Speaker, I reserve the balance of my time.
Mr. WAXMAN. Madam Speaker, may I inquire how much time each side has
and which side has the right to close?
The SPEAKER pro tempore (Mrs. Emerson). The gentleman from California
has 4\1/2\ minutes remaining. The gentleman from Texas has 12 minutes
remaining, and the gentleman from Texas has the right to close.
Mr. WAXMAN. Madam Speaker, I yield the balance of my time to myself.
I just want to point out what the allergy and asthma networks,
mothers of asthmatics, the people who are dealing with this problem,
they say this act gives unprecedented preferential and exclusive
exceptions and financial benefits to Armstrong Pharmaceuticals.
Primatene Mist is specifically not recommended for the treatment of
asthma in the National Institutes of Health NHLBI asthma guidelines.
They don't see a reason this ought to come back on the market. And the
same point of view is expressed by the others that are the
professionals that treat asthma patients.
The effect of this bill will be to take the inventory that this
company has and allow it to go back on the market, from January to
August of 2013, so they can sell it off. It's not going back to the
market; it's just going to allow the inventory to be sold off. A lot of
that inventory is expiring in terms of its efficacy; so a lot of
people, we hope, will not get some Primatene Mist back on the market
that's not going to do them any good.
And there are better alternatives. All the medical groups are telling
us there are better alternatives.
This is a special interest bill. It's a bad bill. It's bad for public
health. It will confuse asthma patients. It provides special treatment
to one company at the expense of its competitors. It's opposed by the
people involved in health, the people who have asthma, the people who
treat asthma, the manufacturers of drugs for asthma.
We don't have to go back to a drug that's been outdated already and
put it back on the market so this company can sell off their inventory.
They say they're going to give all the money to charity. Well, I don't
know what kind of tax breaks they get. I don't see why we should let
them sell off their inventory, especially an inventory that's not going
to be any good beyond August of next year.
This is a bill that we ought to oppose, and I urge all my colleagues
to vote ``no'' on this legislation.
I yield back the balance of my time.
Mr. BURGESS. Madam Speaker, I yield myself the balance of the time.
If advocating for America's asthmatic patients is a special interest
group, guilty as charged. But, Madam Speaker, we have heard so much
stuff
[[Page H6728]]
today that it's almost difficult to refute every point that's been
brought up.
Look, we heard from the ranking member of the Energy and Commerce
Committee that the FDA had deemed the active pharmaceutical ingredient
in Primatene Mist to be dangerous. What is the active ingredient in
Primatene Mist? It's racemic epinephrine.
We heard from the gentlelady from Florida that a product manufactured
in her district was a good product and was available. What's the active
pharmaceutical in Asthmanefrin? Racemic epinephrine. It's exactly the
same product. The difference, of course, is the propellant, and that's
the object of our discussion here today.
Now, I will tell you, as an asthmatic patient, there are things that
I know work better for me than others. I'm willing to go along with a
lot of stuff from the EPA, but I will just tell you, the replacement
propellant that is available in albuterol inhalers does not work nearly
as well as CFC. You don't have to believe me. Go to the Facebook page
that has been developed by asthma sufferers who, one after the other,
will delineate why CFC worked for them when HFA-containing products do
not.
Now, what about Asthmanefrin? There is no propellant. It is delivered
because of an ultrasonic nebulizer, a unique approach and one that,
quite frankly, I welcome.
But let me stress, Madam Speaker, although this product,
Asthmanefrin, is available without a physician's prescription, it's not
generally available over the counter, and I know this because of my own
experience. Number 1, I had to call several pharmacies back in Texas
before I found a Walmart that carried it. After finishing some event
late at night in Fort Worth, I stopped by the Walmart near my home that
I had already talked to that I knew they had the product there. I went
in, but the pharmacy was closed. The pharmacist was gone.
Now, you can buy a vast panoply of almost anything else over the
counter in the pharmacy, off the pharmacy shelves at Walmart--in fact,
you used to be able to pick up two Primatene Mist inhalers for $30
before January 1 of this year--but no Asthmanefrin was available. When
I questioned why, they said that is something that has to be dispensed
by the pharmacist. In other words, it's behind the counter, not over
the counter.
What does that mean as a functional issue?
If an asthmatic patient woke up at 2 that morning and said, Oh, my
golly, I should have never ridden that horse, I should have never
petted that cat, I guess the mountain cedar bloomed down by Waco
because now I've got a snoutful and I cannot breathe, and they go down
to the Walmart, the Walmart's open, the store's lit up, the shelves are
full of product, but Asthmanefrin is not available to that patient.
They'll have to come back at 9 in the morning when the pharmacist is on
duty that can dispense the product to them.
Now, I would also point out that there is a cost differential between
Asthmanefrin and Primatene Mist. We've heard a lot about costs and
profits and who we're helping and who we're not. The cost for the
starter kit for Asthmanefrin is right at $50. At Walmart in my district
it was $49.96. A boxful of the packets of the medicine that is
necessary to place into the machine to dispense costs $27 for a box of
30. And I'm not that good at math, but that's about 92, 93 cents per
packet, one packet per treatment.
How many treatments are in this? I don't know. I've never used one
completely. I always lose them before I get to the end. But it's
advertised to be between 250 and 275 treatments.
The cost differential, a little bit less than 6 cents for this, 93
cents for this per treatment episode. Not a big deal in days you're
talking about medicines that might cost $250, $280 a month for
maintenance therapy for asthma. Yeah, the cost is negligible, but for
some people it's not. For some people that represents a significant
expenditure.
This, I can carry in my pocket. I can bring it to the House floor. If
someone's smoking a cigar in one of the anterooms and I get a puff of
that, I'll have this available when I get to the House floor.
This is harder to carry in your pocket, not impossible, but much
harder to carry in your pocket.
There is a convenience factor. Dean of the House Dingel mentioned
that when he talked about his efforts to preserve products for patients
with asthma. A little less user friendly to go through the multiple
steps for Asthmanefrin as opposed to squeezing the Primatene Mist
bottle and dispensing the medicine where it needs to go into a
patient's chest.
The other over-the-counter products are absolutely not equivalent to
Primatene. Primatene tablets are, indeed, still available. But what are
Primatene tablets? They're ephedrine. That's the active ingredient in
some of the diet pills that the FDA pulled off the market a few months
ago. Yeah, ephedrine will help you if you're in a tight spot with your
breathing, but it's not instantaneous. It's about 30 minutes away after
you take the pill.
{time} 1430
And you want to talk about something that makes your heart race, it's
not Primatene Mist, but the Primatene tablets will do it every time
it's tried.
Madam Speaker, here's the real issue: Should we let elites at the
Federal agency dictate to our asthma patients in our districts what
they can and can't have?
This is one of those instances where I say the Federal agency has
gone too far. Ranking Member Waxman said that the FDA didn't need to
ban Primatene Mist because the EPA had already done it. By what
authority does the EPA regulate medicines that I prescribe for my
patients? There is no such authority, unless I missed something and we
gave them authority where none existed before.
This is about common sense. This is about doing the right thing for
the American people. We took away their toilets. We took away their
lightbulbs. For heaven's sake, let's not take away their asthma
inhalers.
I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Texas (Mr. Burgess) that the House suspend the rules and
pass the bill, H.R. 6190.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Ms. CASTOR of Florida. Madam Speaker, on that I demand the yeas and
nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further
proceedings on this question will be postponed.
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