Albany Update in Light of Ongoing Epi Shortages and Possible Price Fixing

It was great to have the chance to meet in person with our legislators at our Food Allergy Awareness Day, and we are gratified for all their support of our efforts. However, we remain concerned about recent actions by large pharmaceutical companies who produce epinephrine and its generics. There are reports of possible price fixing, intentional shortages, and expiration dates that are much too brief. Read below about our specific concerns and what you can do to help.

2019 May 19 Albany Food Awareness Event-AM Thomas J. Abinanti, AM David Buchwald and Jon Terry
(R to L) AM Thomas J. Abinanti, AM David Buchwald and Jon Terry.
Photo by N. Kemp

Successful Food Allergy Awareness Day Event, but the Epi Crisis Becomes More Complicated

By Jon Terry
June 8th, 2019

Greetings from western New York. For the past few years, New York State lawmakers have enthusiastically sponsored Food Allergy Awareness Day at the state capitol in Albany. The Allergy Advocacy Association acted in concert with AM Thomas J. Abinanti and NYS Senator Gustavo Rivera with planning and scheduling for our event held on May 15th. We hosted more than thirty adults and children, most of them coping with life-threatening allergies each and every day. Our event featured many meetings with Senators, Assembly Members and their staffs; most lawmakers did express support for our program of action. At our exhibit booth in the Legislative Office Building, reporters for local media outlets conducted several interviews with lawmakers and visitors. In my opinion I think it was a great day! Our association firmly believes this annual event is very important for all individuals and families at risk for anaphylaxis in New York State.

Concerning the pharmaceutical industry and epinephrine — a life-saving medication for anaphylaxis — our association is very concerned about recent developments here in NY. I am particularly disturbed by news media reports that would seem to indicate irresponsible (and possibly illegal) corporate actions. Please see a brief summary listed below:

  • Epinephrine Auto-Injector (EAI) device expiration dates are shown to be too short. New research from The Journal of Allergy and Clinical Immunology suggests expiration dates could be much longer. By establishing new dates, the unnecessary purchasing of new devices would help decrease medical expenses for patients. 

New research published in The Journal of Allergy and Clinical Immunology demonstrates that epinephrine auto-injectors (EAIs) meet potency requirements set by the Food and Drug Administration (FDA) years after the labeled expiration date. This study adds to a growing body of research that indicates auto-injector expiration dates are currently too short and could be extended.

  • EAI device manufacturers of both brand names and generic drugs have been accused of price fixing and market manipulation. 

Leading drug companies including Teva, Pfizer, Novartis and Mylan conspired to inflate the prices of generic drugs by as much as 1,000 percent, according to a far-reaching lawsuit filed on Friday by 44 states. The lawsuit suggests that sales of the EAI device (a life-saving medication) might have been manipulated.

  • The worldwide shortage of EAI devices threatens the lives of many patients. 

The Food and Drug Administration (FDA) continues to list shortages of epinephrine auto-injector (EAI) devices on the FDA Website more than one year after their first shortage announcement in 2018. 

As the founder of the Allergy Advocacy Association, I suspect that….

  • The manufacturers of EAI devices were always aware that epinephrine had a much longer shelf-life than they were recommending to their patients and consumers.
  • Price fixing by both the brand name and generic manufacturers of EAI devices is a very distinct possibility.
  • Market manipulation through artificially created shortages by all manufacturers of EAI devices cannot be discounted.
  • The state and federal agencies have failed to protect patients and consumers of EAI devices from fraudulent labeling and pricing practice.

I now believe even more individuals are at risk for anaphylaxis emergencies from life-threatening allergies. A thorough investigation of pharmaceutical manufacturers, corporate-owned retail pharmacies, pharmacy benefit managers (PBMs), insurance providers, etc. is necessary and warranted. We must act now to protect the lives of NYS residents before any fatalities occur.  

Anyone who wants to file a complaint about the issues listed above must contact the Food and Drug Administration (FDA) Consumer Complaint Coordinators and the Federal Trade Commission online complaint assistant.

Our association will continue to act as a clearing house of current information; we can use our Website and monthly e-newsletter to educate the public at large along with individuals and families with life-threatening allergies. Now more than ever our association needs ideas, suggestions, volunteers and donations.

PLEASE get involved! Best wishes to one and all.

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