Got asthma? Need an inexpensive inhaler? Tough!

[Patriot]

Obama Administration Set to Ban Asthma Inhalers Over Environmental Concerns
3:00 PM, Sep 23, 2011 • By MARK HEMINGWAY
The Weekly Standard


Remember how Obama recently waived new ozone regulations at the EPA because they were too costly? Well, it seems that the Obama administration would rather make people with Asthma cough up money than let them make a surely inconsequential contribution to depleting the ozone layer:

    Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the     federal government's latest attempt to protect the Earth's atmosphere.

    The Food and Drug Administration said Thursday patients who use the epinephrine inhalers to treat mild asthma will need to switch by Dec. 31 to other types that do not contain chlorofluorocarbons, an aerosol substance once found in a variety of spray products.

    The action is part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, a region in the atmosphere that helps block harmful ultraviolet rays from the Sun.

    But the switch to a greener inhaler will cost consumers more. Epinephrine inhalers are available via online retailers for around $20, whereas the alternatives, which contain the drug albuterol, range from $30 to $60.

The Atlantic's Megan McArdle, an asthma sufferer, noted a while back that when consumers are forced to use environmentally friendly products they are almost always worse.


Story:  http://www.weeklystandard.com/blogs/obama-administration-ban-asthma-inhalers-over-environmental-concerns_594113.html

[flintauqua]

"FDA first began public discussion about the use of CFCs for epinephrine inhalers in January 2006. FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008."

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm247196.htm

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Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
A Rule by the Food and Drug Administration on 11/19/2008

Publication Date:  Wednesday, November 19, 2008

Summary:  The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.

http://www.federalregister.gov/articles/2008/11/19/E8-27436/use-of-ozone-depleting-substances-removal-of-essential-use-designation-epinephrine#p-5

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Please remind us who was in the White House in 2008.

[Warph]

I lucked out, so far anyway... I use Xopenex HFA; Advair Diskus 250/50; Spiriva Handihaler.  Why?  It must have been those damn french cigarettes!

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm082370.htm

Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons

Many inhalers that do not use chlorofluorocarbons (CFC) are already available for the treatment of asthma and chronic obstructive pulmonary disease. These products aren't necessarily "official" direct alternatives to CFC Metered Dose Inhalers but may in many patients serve as a useful medication that could replace the need for a particular CFC Metered Dose Inhaler. FDA will determine official alternatives by using the criteria established through notice-and-comment rulemaking, as it has done with albuterol.

Information regarding FDA's approval of these inhalers is available here. As FDA approves new non-CFC inhalers, we will add that information to this page.

Drugs are listed in alphabetical order by active moiety, with specific brands available listed under each active moiety. What is an active moiety? An active moiety is the part of a drug that makes the drug work the way it does. Many different drug products may be marketed with the same active moiety.
Proventil HFA (albuterol sulfate inhalation aerosol) Regulatory history including label from Drugs@FDA1

Ventolin HFA (albuterol sulfate inhalation aerosol) Regulatory history including label from Drugs@FDA2

ProAir HFA (albuterol sulfate inhalation aerosol) Regulatory history including label from Drugs@FDA3

QVAR (beclomethasone dipropionate inhalation aerosol) Regulatory history including label from Drugs@FDA4

Pulmicort Turbohaler (budesonide inhalation powder) Regulatory history including label from Drugs@FDA5

Pulmicort Flexhaler (budesonide inhalation powder) Regulatory history including label from Drugs@FDA6
Symbicort (budesonide and formoterol fumarate) Inhalation Aerosol Regulatory history including label from Drugs@FDA7
Alvesco (ciclesonide) Inhalation Aerosol Regulatory history including label from Drugs@FDA8
Flovent HFA (fluticasone propionate HFA inhalation aerosol) Regulatory history including label from Drugs@FDA9

Flovent Diskus (fluticasone propionate inhalation powder) Regulatory history including label from Drugs@FDA10

Foradil Aerolizer (formoterol fumarate inhalation powder) Regulatory history including label from Drugs@FDA11

Atrovent HFA (ipratropium bromide HFA inhalation aerosol) Regulatory history including label from Drugs@FDA12

Xopenex (levalbuterol sulfate HFA inhalation aerosol) Regulatory history including label from Drugs@FDA13

Asmanex Twistihaler (mometasone furoate inhalation powder) Regulatory history including label from Drugs@FDA14

Serevent Diskus15 (salmeterol xinafoate powder for inhalation) Regulatory history including label from Drugs@FDA16

MedWatch Safety Information on Serevent17

ADVAIR Diskus (salmeterol xinafoate / fluticasone propionate powder for inhalation) Regulatory history including label from Drugs@FDA18

ADVAIR HFA (salmeterol xinafoate / fluticasone propionate) Regulatory history including label from Drugs@FDA19

Spiriva Handihaler (tiotropium bromide inhalation powder) Regulatory history including label from Drugs@FDA

[srkruzich]

"FDA first began public discussion about the use of CFCs for epinephrine inhalers in January 2006. FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008."

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm247196.htm

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Please remind us who was in the White House in 2008.

The damocrats was in  control in 2006 thru 2010.  You folks seem to forget that fact! 

[srkruzich]

This is a push to put meds out of reach of the normal folks.

[Diane Amberg]

It will be much more expensive in most cases because I'll bet they will make it totally by prescription. It's rather ironic that it's so often junk in the air that causes asthmatics so much trouble and yet now we're going to make the air better at the expense of the people who were made sick by it.
Albuterol is generally better as a rescue inhaler in the long run. But with all the advertizing the epinephrine inhalers get, somebody has to pay for all that advertizing and it convinces people it must be better somehow. I wonder how the pharmacists will feel.
Frankly, I'm totally sick of everything being turned into a political issue! CFC's have been slowly but surely replaced in products for many years. In many cases the fluorocarbons have been replaced with butane or propane, which of course have flammability issues. Can't put those in something someone is going to breathe.
People should be able to work with their doctor and/or their respiratory therapist and not the local politician! GRRRR!

[Patriot]

People should be able to work with their doctor and/or their respiratory therapist and not the local politician! GRRRR!

This action by the EPA is just one more sacrifice being offered to the gods of environmentalism by the followers.  Reverend Gore must be pleased.  You can bet big Pharma is thrilled.

[readyaimduck]

"so....(sitting around the round table throwing paper airplanes) we decide that (pick a disease) needs to be deemed detrimental to our health, so we get our bedparnters (Pharma-psuedo boitches) to concoct an antidote that will eventually cause other side effects...
But hey!  we have an app for that too!  Then we change Presidents....and do it all over again
Same pill, different trip.

Did I get this close?ready

[Warph]

This article appears on FDA's Consumer Updates page10, which features the latest on all FDA-regulated products.
Date Posted: April 13, 2010

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm207864.htm

Which CFC inhalers are being phased out, and when?
Dates for the phase-out of each CFC inhaler have been set. After those dates, these CFC inhalers cannot be made, dispensed, or sold in the United States.

The seven CFC inhalers are listed here by their brand names, along with their manufacturers and the last date they can be sold in the United States. The generic names for the medicines appear in parentheses.

***Tilade Inhaler (nedocromil), made by King Pharmaceuticals, last date for sale: June 14, 2010
***Alupent Inhalation Aerosol (metaproterenol), made by Boehringer Ingelheim Pharmaceuticals, last date for sale: June 14, 2010
***Azmacort Inhalation Aerosol (triamcinolone), made by Abbott Laboratories, last date for sale: Dec. 31, 2010
***Intal Inhaler (cromolyn), made by King Pharmaceuticals, last date for sale: Dec. 31, 2010
>>>Aerobid Inhaler System (flunisolide), made by Forest Laboratories, last date for sale: June 30, 2011
>>>Combivent Inhalation Aerosol (albuterol and ipratropium in combination), made by Boehringer Ingelheim Pharmaceuticals, last date for sale: Dec. 31, 2013
>>>Maxair Autohaler (pirbuterol), made by Graceway Pharmaceuticals, last date for sale: Dec. 31, 2013

Four of the seven CFC inhalers are no longer being made. Three CFC inhalers currently in use—Aerobid, Combivent, and Maxair—will be phased out over the next one to three years. These later phase-out dates give patients time to talk with their health care professionals and switch to another medicine.

FDA will continue to reach out to companies, health care professionals, and patients to ensure a smooth transition.

[readyaimduck]

ensure a smooth transition

yes, I am sure that will happen.  And the comment will be "we have a 'lube' for that.

ready