This year the Food and Drug Administration (FDA) has made important decisions affecting all Americans. Improving all package labelling to better informing consumers about food allergens is a major priority for our association.
The Food and Drug Administration (FDA) sent proposed guidance “Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry” to the Office of Management and Budget (OMB) for review. While this voluntary guidance falls short of the mandatory sesame allergen labeling that we have been advocating for, we feel it is a promising step in the right direction. This is a result of the FDA’s 2018 request for comments from the public on sesame allergy and their review of those comments from the food allergy community.
After many months of activism and advocacy, important legislation is progressing through the US Congress helping central schools across America better protect and support students at risk for dangerous allergic reactions.
Allergy & Asthma Network today applauds the U.S. House of Representatives for passing the School-Based Allergies and Asthma Management Program Act, H.R. 2468 — but our work is not done!
The legislation, long a priority for Allergy & Asthma Network and a host of health and patient organizations, now heads to the U.S. Senate for consideration. The Network will continue its advocacy efforts, urging passage of the bill before the end of the year so it becomes law.
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.
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.
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.
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.
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.