FDA Regulations Prevent Release of Cheap EpiPen Alternative

FDA Prevents  Immediate Release of a $50 EpiPen Alternative

by Aya Katz

Epinephrine is a substance that helps with the treatment of severe allergic reactions. For those who suffer from unpredictable but life threatening allergies, the ability to inject this substance immediately without any delay could be the difference between life and death. Ever since the price of the EpiPen, an FDA approved device that delivers epinephrine directly into the bloodstream, has gone up from $57.00 to $600, the public has been looking for legal alternatives. Dr. Douglas McMahon of the Allergy and Asthma Center in Eagan, Minnesota, has invented an alternative device, much smaller than the Epipen, which would sell for $50.00. There is just one problem: he needs to raise two million dollars to put his invention through the tests required by the FDA before his AllergyStop device can be legally marketed to the public.

According to CBSLocal in Minnesota, “McMahon says companies like Mylan may have lost sight of patient needs and are catering to investors,” but the FDA certification required for any medical device is at the heart of the problem. Once investors are required to shell out two million dollars in order to achieve certification by the Federal agency, it would stand to reason that they would want a return on their investment. It does not matter that the parts of the device and its individual components cost next to nothing to make. There is no possible way that the device will not end up being expensive, if the FDA certification process is so expensive that it creates a monopoly.

However, patients do not need to hold their breath until a new inexpensive device becomes FDA certified. There has always been a cheap alternative available, according to a letter in the Zaneville Times Recorder:

Before EpiPen we had an ampoule of epinephrine for $5 and a tuberculin or insulin syringe for $1 together in a baggie. Emergency happens, pop the ampoule and draw contents into the syringe in 15 seconds. Inject into any skin on the patient. Call 911 and get the patient to the ER.

Every person who is subject to the problem should have the baggie in a fanny pack. Total cost is $6.

Let the EpiPen bandit sit with his overpriced stock. The ampule of epinephrine and syringe is available today with physician prescription.

Maybe if we did away with the requirement of the physician’s prescription, everyone could actually afford the cheapest remedy. At the moment, a physician’s prescription costs about one hundred dollars. To those without medical insurance, this can be a formidable hurdle in itself. If we did away with the requirements of Obamacare that everyone must pay for insurance and repeal the mandated employer-paid  medical insurance for the majority of employees, then maybe a visit to the doctor would not be that expensive, either. The government-created monopolies at every step of our medical economy are what makes healthcare so hard to come by.

It is no picnic to be sick and in need of medical assistance. But government involvement in medical matters makes it so much harder. Making an EpiPen alternative is easy. Paying off the government so they will allow you to use it is the hard part.

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