E-Greetings from the Allergy Advocacy Association

September 2020

Greetings. Our association sincerely hopes you and your family have had an enjoyable summer season (all things considered!).

In this month’s issue you will find a profile of Melissa Scheichl (aka The Allergy Mom®) as well as a description of and call to action regarding the FASTER ACT from Food Allergy Research and Education (FARE). There is also a description of two possible game changing treatments, “Dissolving Epinephrine and At-Home Asthma Injections” Finally you can learn more about Teva Pharmaceuticals possible indictment by the U.S. Department of Justice (DOJ) as part of a price fixing scheme.

Concerning our annual Action Awards Celebration, in response to the coronavirus pandemic, we are going “VIRTUAL!” The date will be Wednesday October 21st at 7:00 pm. Please plan to join us for a very entertaining evening as we honor award winners, highlight some of our advocacy efforts and enjoy some early Halloween trick or treating.

Regarding our Epi Near You NY anaphylaxis emergency training program, this year’s event will be “VIRTUAL” via our website. Our very first web-based ENYNY training seminar will premiere on Wednesday October 28th from 12 to 1pm. For more information, visit our Website at www.AllergyAdvocacyAssociation.org

Stay safe and healthy! Best wishes to one and all!

The Allergy Mom® Melissa Scheichl Provides Education and Support

Author, educational presenter, clinical social worker, psychotherapist and advocate are just a few of the many roles that Melissa Scheichl occupies. All these roles came about from being the mother of children with severe allergies. Her journey of learning and experiencing the impact of life threating allergies on her children propelled her to create, in 2010, the website and associated blog at TheAllergyMom.com. Since then Melissa has helped provide support and a forum for families to share their experiences as well as finding ways to educate the public about life threatening allergies.

The Allergy Mom® Melissa Scheichl Provides Education and Support

Melissa Scheichl

By Kristen Stewart
September 9th, 2020

Growing up Melissa Scheichl (aka The Allergy Mom®) of the Greater Toronto Area of Ontario, Canada, had both seasonal and food allergies and her mother suffered a dangerous anaphylactic reaction to a bee sting. As challenging and scary as these experiences were, however, allergies did not become a major focus of her life until her children were born almost 16 and 14 years ago.

“As a mom, nothing is more important than the health and well-being of your children,” she said. “My son Andrew's severe allergies to dust, dog dander and environmental allergies educated me on how to make our home and lives safer when dealing with environmental allergies. I learned about eczema, indoor air quality measures and how to alleviate seasonal and environmental allergy symptoms.” As if that wasn’t enough to handle, several years later her daughter Kate was born and diagnosed with severe life-threatening food allergies and asthma.

Melissa and her family watched Kate constantly, making sure she didn’t put goldfish crumbs or anything else dangerous in her mouth. However, just before her third birthday she had a bite of a granola bar that contained almonds. Despite testing negative to tree nuts on a skin test they quickly learned ingesting a food could cause a much different reaction. She suffered a dangerous attack of anaphylaxis.

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The FASTER Act: What It Does and Why YOU Need to Help Pass It

Uncle Sam -- I Need You to Pass the Faster Act

The FASTER Act: What It Does and Why YOU Need to Help Pass It

Probably everyone has heard the expression “the squeaky wheel gets the grease.” What they may not have heard is the reason why; “because it needs it!” Congress is currently considering the FASTER Act which will, amongst other things, expand the FALCPA “Top 8” allergens to include sesame as the ninth. (FYI, FALCPA stands for Food Allergen Labeling and Consumer Protection Act). Here you will find a summary of what is the FASTER ACT complied by Food Allergy Research and Education (FARE) as well as information on their Courage at Congress Campaign to encourage your legislators to co-sponsor and show their support for the FASTER Act.

By Dave Bloom
2020/08/26

To put it bluntly, the US is not doing an adequate job of protecting individuals coping with food allergies, EOE and FPIES. The Food and Drug Administration’s (FDA) recent loosening of already lax labeling regulations to accommodate manufacturers during the COVID pandemic is a prime example of how we are often left to fend for ourselves, placing our community at risk from cross-contact reactions, anaphylaxis, and plain ignorance of the dangers and prevalence of food allergy.

The FASTER act being championed by Food allergy Research and Education (FARE) will move the country in the right direction. To summarize, the act will:

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Allergy News: Dissolving Epinephrine, At-Home Asthma Injections

Having a potential life threating allergy impacts a person’s life in many ways. One way is the medicine you use to treat your allergy and how it is administered. Now what if the Food and Drug Administration (FDA) approved a treatment that could make it easier to use, as in the case of dissolving epinephrine, or more convenient as in the case of at-home asthma injections, it could be game changer for allergy suffers as well as their friends and family. Read here about the efforts of two pharmaceuticals companies that are attempting to create these game changers.

Allergy News: Dissolving Epinephrine, At-Home Asthma Injections

lab technician

By: Jenifer Goodwin
August 26, 2020

An Oral Epinephrine ‘Film’ to Stop Allergic Reactions?

The hesitancy of some people to use an epinephrine auto-injector for anaphylaxis has led to a longstanding interest in developing an alternative that doesn’t involve a needle.

While efforts to develop an oral, sublingual epinephrine pill have yet to succeed, Aquestive Therapeutics, based in New Jersey, just launched a Phase 1 clinical trial of an epinephrine “film” that dissolves under the tongue. The trial, which will enroll up to 28 people, will compare the effectiveness of the film with epinephrine given by injection.

Epinephrine Film
Aquestive Therapeutics

“We are focused on providing the first highly portable, easy-to-administer and anxiety-free sublingual film medication to treat this serious condition,” said Keith Kendall, Aquestive Therapeutics president and CEO, in a statement.

On August 10, the U.S. Food and Drug Administration’s (FDA) granted the film fast track designation to expedite drug development and review.

In a previous Phase 1 “proof of concept” study released in 2019, the company reported epinephrine delivered via oral sublingual film was absorbed as rapidly as epinephrine from an auto-injector, and that the time it took to reach maximum concentration was similar to the EpiPen and Auvi-Q auto-injectors.

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Teva Posed to Face Charges in Drug Price-Fixing Probe

Teva Pharmaceuticals, one of the world’s largest makers of generic drugs, may soon be indicted by the U.S. Department of Justice. This most recent investigation by the DOJ focused on Teva and other drug companies conspiring to fix prices on several widely used generic medications.

Teva Posed to Face Charges in Drug Price-Fixing Probe

TEVA logo

By David McLaughlin
August 25, 2020

DOJ preparing criminal antitrust complaint against drug-maker

U.S. prosecutors are preparing to charge Teva Pharmaceutical Industries Ltd. with conspiring with competitors to raise prices for generic drugs, according to a person familiar with the matter.

The Justice Department is planning to charge Teva as soon as Tuesday after the company rebuffed a settlement that would have required paying a criminal penalty and admitting wrongdoing, said the person, who declined to be named because the matter is confidential.

Teva’s U.S.-traded shares fell as much as 6% on the news and were down 2.3% to $9.41 at 3:25 p.m. in New York. A spokesperson for the company, which is based in Israel, declined to comment.

Charges against Teva, the world’s largest generic-drug maker by market value, would mark the most significant case to come out of the Justice Department’s years-long investigation into allegations that companies conspired with one another to prop up the prices of certain widely used medications. Nine of every 10 prescription drugs dispensed in the U.S. are generics.

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