Allergies come in all shapes and sizes ...
Just like allergy sufferers. And they are on the rise. For many people allergies can range from sniffling and sneezing to skin rashes to gastrointestinal issues. A certain percentage, however, have more than these uncomfortable symptoms to deal with. Anaphylaxis, a serious life-threatening reaction, causes approximately 1,500 deaths a year in the United States alone. Clearly, allergies are nothing to sneeze at!
Articles for Advocacy
One would think that with the frequency of peanuts being handed out on a typical airline flight, that the carriers would certainly have epinephrine on hand. But sadly this is not the case. Federal laws that would require airlines to carry EpiPens failed to pass in 2016 and Airlines for America, the carriers’ trade association, received a Federal Aviation Administration (FAA) four-year exemption from carrying drugs such as epinephrine in times of drug shortages. So there is a high probability that you could be left high and dry if you were experiencing signs of anaphylaxis while flying in an airplane. Please contact your congressman to ask for their support in passing a law requiring airlines to carry lifesaving epinephrine.
At 30,000 Feet, Why We Can’t Count on Epinephrine Vials on an Airplane
By: Lianne Mandelbaum
October 10, 2019
Back in 2016, the food allergy community had high hopes for a bipartisan Senate bill that would have required all U.S. airlines to carry epinephrine auto-injectors on every flight, and to train crews to use them. But the proposed law failed to pass.
Then in the summer of 2019, two high-profile reactions occurred on airplanes, involving stories of difficulty either accessing epinephrine or getting an additional dose of the lifesaving drug. This has given a renewed sense of urgency to lobbying to get epinephrine auto-injectors into airline emergency kits. From a few senators to physicians, a new food allergy coalition called CLEAR, proponents like the non-profit FARE and advocates like me, all of us have been urging this change.
Most of us are certainly aware that the number of people with severe food allergies is increasing rapidly. But there is hope for the future, as an advisory panel at the Food and Drug Administration (FDA) recently voted to approve a new treatment for peanut allergies in children. Called Palforzia, the drug seeks to treat peanut-allergy sufferers by exposing them to increasing amounts of pharmaceutical-grade peanut protein.
But American regulators may soon approve a treatment
The Economist
Oct 3rd, 2019
FOOD ALLERGIES have plagued humans for thousands of years. In the fifth century BC Hippocrates noted that although some people could eat their fill of cheese “without the slightest hurt…others come off badly.” The difference, he observed, “lies in the constitution of the body.”
Nearly all foods are capable of triggering allergic reactions in humans, and today these are more prevalent than ever, for reasons that are poorly understood. In America, as many as one in 12 children is reckoned to have one. None is more feared than the peanut. A paper by researchers at the Mayo Clinic in Minnesota found that the number of emergency-room visits by American children suffering allergic reactions to nuts, seeds and other food has tripled in ten years (see chart, left panel). Peanuts topped the list, sending nearly six in 100,000 children to hospital in 2014. More than one child in 50 is allergic to peanuts; among one-year-olds, one in 20. This figure has tripled since 2001 (see chart).
There is justice at last, with Mylan, the maker of EpiPens, being fined $30 million for over charging Medicaid by classifying it as a “generic” drug, rather than a branded one. Also, investors were kept in the dark about Mylan’s EpiPen misclassification and the potential loss Mylan faced as a result of the pending investigation.
Mylan to Pay $30 Million for Disclosure and Accounting Failure Relating to Epi-Pen©
By News Wire
Washington D.C., Sept. 27, 2019
The Securities and Exchange Commission today announced charges against Pennsylvania-based pharmaceutical company Mylan N.V. for accounting and disclosure failures relating to a Department of Justice (DOJ) probe into whether Mylan overcharged Medicaid by hundreds of millions of dollars for EpiPen, its largest revenue and profit generating product. Mylan agreed to pay $30 million to settle the SEC’s charges.
According to the SEC’s complaint, Mylan classified EpiPen as a “generic” drug under the Medicaid Drug Rebate Program, which resulted in Mylan paying much lower rebates to the government than if EpiPen had been classified as a “branded” drug. The complaint alleges that in October 2014, the Centers for Medicare and Medicaid Services (CMS) informed Mylan that EpiPen was misclassified as a generic drug. Starting in November 2014, and continuing for nearly two years, the DOJ conducted a civil investigation into whether Mylan misclassified EpiPen and thereby overcharged the government for EpiPen sales to Medicaid patients. During the investigation, DOJ issued multiple subpoenas and investigative demands, rejected Mylan’s arguments to close the investigation, and indicated its intent to sue Mylan if Mylan failed to make a settlement offer. As alleged in the complaint, Mylan produced documents and other information to DOJ, including providing potential damages calculations and making offers of settlement.
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