[Congressional Record (Bound Edition), Volume 158 (2012), Part 12]
[House]
[Pages 16968-16973]
[From the U.S. 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:

[[Page 16969]]



                               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 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

[[Page 16970]]

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 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.

[[Page 16971]]

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. 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 problems 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 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

[[Page 16972]]

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 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

[[Page 16973]]

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.
  Mr. GENE GREEN of Texas. Madam Speaker, I support the Asthma Inhalers 
Relief Act, H.R. 6190. This bill is simple; it will allow remaining 
stocks of Primatene Mist to be made available to asthma patients. This 
is a drug that was on the shelves for decades, but was removed due to 
environmental concerns regarding CFCs. Primatene was not removed due to 
safety concerns.
  Limiting releases of CFCs is important and we must make sure that 
consumer products do not contain these harmful chemicals. However, the 
small remaining amount of Primatene poses no real threat to the 
environment and could potentially save the lives of Asthma patients in 
the midst of an attack. Right now there are no over-the-counter rescue 
inhalers available.
  Releasing the remaining doses of Primatene is a temporary solution 
until a non-CFC inhaler is approved by the FDA. I have heard from 
constituents of mine who would greatly benefit from access to this 
medicine. If these inhalers endangered their safety, of course, it 
would not be appropriate to put them back on the shelves, but that is 
not the case.
  I urge my colleagues to support this bill.
  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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