Navigation Links
Makers Of Over-the-Counter Inhaler Leading Fight To Have Product Back On Market After Removal Due To Environmental Treaty
Date:7/18/2012

WASHINGTON, July 18, 2012 /PRNewswire-USNewswire/ -- The makers of Primatene® Mist have launched a campaign to put the over-the-counter inhaler back on the market in the United States, after it was banned because it contains a small amount of chlorofluorocarbons (CFCs), leaving millions of asthmatics without an over-the-counter inhaler. The "Bring Back My Primatene®" campaign will promote a Facebook group and a petition to the Environmental Protection Agency (EPA), encouraging the agency to allow putting the remaining supply of the over-the-counter inhaler back on the market and support federal legislation with the same objective. 

Representatives of Amphastar, the company that makes Primatene® Mist, will announce the campaign as part of a House Energy and Commerce Committee Energy and Power subcommittee hearing on the "Asthma Inhalers Relief Act of 2012". The hearing will be held on July 18, 2012 at 10:15 a.m. in room 2123 of the Rayburn House Office Building. Witnesses are to be determined.

The Rancho Cucamonga, California-based pharmaceutical company, Amphastar, promises that it will donate all of the net profits from the sale of the "brought back" over-the-counter inhaler (approximately $6.50 per unit of product sold) to charity.

Primatene® Mist has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms, including shortness of breath. It was the only over-the-counter inhaler available before it was banned for sale by the EPA after December 31, 2011. This was done in accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer, which was signed by the United States in 1987. That treaty determined that CFCs, which include the chemical used to propel inhalants in Primatene® Mist, were damaging the ozone layer in the upper atmosphere and should be discontinued.

The EPA has the ultimate authority to keep Primatene® Mist on the market, and has issued waivers for more expensive inhalers which also contain CFCs and require a doctor's prescription. But the EPA has not granted such a waiver to the makers of Primatene® Mist.

Before the ban, two to three million asthma sufferers in the United States relied on Primatene® Mist, because they did not have health insurance or the means to pay for a doctor's visit to get a prescription, or simply because they preferred Primatene® Mist to prescription inhalers.

"We are fighting to get Primatene® Mist back on the market, and donating all of the net profits to charity, because we believe in our product, and want it to be abundantly clear we are doing this for the millions of Americans who used to rely on Primatene® Mist and not to make money," said Jason Shandell, vice president and general counsel of Amphastar Pharmaceuticals.  "We all strive to protect the environment, but we believe it is essential to have an over-the-counter inhaler available until a replacement without CFCs is available. For the millions of Americans suffering from asthma and lacking health insurance, or those with health insurance who found Primatene® Mist was their best treatment option, we are hopeful to get these inhalers back on the market as soon as possible."

Key facts:

  • Primatene® Mist is an over-the-counter (OTC) inhaler for asthma patients that has been used safely by millions of people for more than 46 years to help them cope with asthma related symptoms including shortness of breath. It is manufactured by Armstrong Pharmaceuticals, Inc. which is a wholly-owned subsidiary of Amphastar Pharmaceuticals, Inc.
  • There is currently no OTC inhaler for asthma patients available.  If someone without a prescription for an inhaler is suffering from asthma symptoms, they either need to go to the emergency room -- which can cost thousands of dollars -- or simply endure the pain and shortness of breath. 
  • The existing supply of Primatene® Mist inhalers (approximately 1 million units) expire in 2013, and the EPA has not granted permission for additional CFCs to be used to create additional inhalers.  If the EPA allows the current supply back on the market, it would only be until August 2013.
  • Amphastar/ Armstrong has received thousands of complaints and inquiries from people who used, benefited from and want continued access to the product. 
  • Amphastar has repeatedly asked for guidance from the EPA, and received no response, about how to dispose of the current supply of Primatene® Mist inhalers without releasing the CFCs into atmosphere. It is better to allow the approximately 1 million currently available units be made available to help people suffering from asthma, rather than to waste them and still have the CFCs escape into the environment.
  • There are prescription inhalers still on the market which contain CFCs and they are being used by asthma sufferers.  It is difficult to understand why some prescription inhalers containing CFCs are still allowed to be sold, whereas Primatene® Mist, which was the only OTC inhaler, has been banned.

 

 


'/>"/>
SOURCE Amphastar
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. New Video, Website Help Health Plan Sponsors, Patients and Policy Makers Maximize Prescription Drug Benefits, Reduce Wasteful Spending
2. Statement from Mary Vogt, President of Home Access Health Corporation, manufacturer of the Home Access HIV-1 test system, the only over-the-counter HIV test previously approved by the FDA for at-home use.
3. Cannabis Science Gets Set to Release "Phytiva" Its Newest Brand of Over-the-Counter Skin and Nutraceutical Product Lines Through its Newest Venture Phytiva Pharmaceuticals Inc.
4. Asthmapolis Receives FDA Clearance for Asthma Inhaler Sensor Technology and Accompanying Software System
5. Rapid Fire Marketing Funds Development of Second Generation Vapor Inhaler
6. Pulse Oximetry Screening Hailed as the New Milestone to Combat Critical Congenital Heart Disease - Signal Extraction Technology Leading the Way in Large, Independent Clinical Studies
7. AstraZeneca and Leading Academic Scientists to Collaborate on Alzheimers Disease Research
8. Court Preliminarily Deems Millennium Laboratories Press Release Misleading
9. FMC Corporation Acquires Phytone, Ltd., a Leading European Natural Colors Business
10. Denton Vacuum Ships Breakthrough Wafer-level Optics Development System to Leading German R&D Organization
11. Leading Pension Annuity Provider Legal & General, Celebrates 175 Years
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... , May 25, 2016  Granger Diagnostics today ... test for wounds and infections. This test ensures ... and select viruses. The test requires only a ... David G. Bostwick , MD, ... to facilitate wound healing: "We are excited to ...
(Date:5/25/2016)... , May 25, 2016 ... the precision of circulating tumour DNA (ctDNA) analysis ... the appointment of Professor Clive Morris ... leadership across the clinical development programme, scientific collaborations, ... help deliver significant improvements in clinical outcomes for ...
(Date:5/24/2016)... -- Cirujanos holandeses han puesto en marcha ... a compartir sus mejores prácticas por el mundo y ... de Europa, África, Asia y ... que combina la transmisión en vivo con mensajería instantánea ... Educación   "Imagine un médico de Medicines sans ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... , ... Despite last week’s media reports hinting at a June rate hike ... March 2017 for an interest rate increase, according to Rajeev Dhawan of the Economic ... Federal Open Market Committee (FOMC) dot charts are of interest to the press for ...
(Date:5/26/2016)... Hampshire (PRWEB) , ... May 26, 2016 , ... ... care products, has been honored with a 2016 When Work Works Award for its ... award, part of the national When Work Works project administered by the Families and ...
(Date:5/26/2016)... , ... May 26, 2016 , ... ... clinical outcomes, hosted members and suppliers for its inaugural Member Conference at the ... their mission of elevating the operational health of America’s healthcare providers. , The ...
(Date:5/26/2016)... ... 2016 , ... Connor Sports, through its Connor Cares initiative, will ... Tamika Catchings Legacy Tour that will commemorate the Indiana Fever legend’s hall-of-fame career ... all forms and levels of the game, Connor Sports has committed to a significantly ...
(Date:5/26/2016)... ... , ... The Woodlands at John Knox Village , Florida’s first Life ... living and healing, celebrated its grand opening, today. The Woodlands at John Knox Village ... Empowered Staff. , “This is an incredibly fulfilling time for John Knox Village as ...
Breaking Medicine News(10 mins):