Advocacy

5/25/20

TMS has become aware that over the weekend, the FDA has quietly announced changes in how food labels are going to be listing ingredients. These changes will include LOOSENING guidelines on naming ingredients in a given food. This potentially puts patients with mast cell disease and food allergies at risk of anaphylaxis and a poor or fatal outcome, as well as any other person at risk of food allergy-induced anaphylaxis. I have asked our Advocacy Committee Chair, Barbara Ruby, to contact Food Allergy Research and Education (FARE),  Food Allergy and Anaphylaxis Connection Team (FAACT), as well as all of the members of the AAAAI Lay Organizations who we work closely with, to come up with a united plan of action against this dangerous and unnecessary legislation. All of TMS will be working with Barbara against legislation that affects our population. Recently, we signed on in support of more stringent labeling of foods, including not listing (spices), but mandating that each spice or flavoring be named. This new legislation passed this weekend is a huge step backward, and we cannot allow it to remain.Additional information from the FDA All of TMS will join in efforts against this change. Thank you.Valerie M. Slee, TMS Chair, Board of Directors and Committees

9/19/19
Dear members of the Mast Cell Disease community,

As always, TMS is committed to representing all mast cell diseases including mastocytosis, mast cell activation syndrome, MCA, and HaT in terms of our resources and mission. We have become aware that our physicians are possibly considering incorporating new criteria to the existing proposed consensus criteria (Valent, et.al.) for mast cell activation syndrome. We are concerned that adding anaphylaxis as a criteria for MCAS may not reflect the patient experience that patients report. In addition, we have reservations about the description of symptomatology in MCAS patients as only episodic to the exclusion of daily symptoms. To this end, we are communicating our concerns to the TMS Medical Advisory Board, the AAAAI Mast Cell Disorders Committee, and the European Competence Network in Mastocytosis. As always, TMS is committed to representing all mast cell diseases including mastocytosis, mast cell activation syndrome, MCA, and HaT in terms of our resources and mission. We look forward to updating you on the response as soon as we receive it.

From the TMS Board of Directors and Committee Chairs

11/12/18
Diphenhydramine Shortage – We need your help!

The Mastocytosis Society, Inc. is continuing to work with pharmaceutical companies and the FDA to help patients during this life-threatening intravenous and injectable diphenhydramine shortage. That said, the fact remains that currently, of the five companies listed on the FDA website, only two are making products that may be available in 2018 but with no guarantee.

We know that many in our patient community rely on this medication to manage and prevent life-threatening mast cell reactions. We are particularly concerned for those most critically-ill.

While our work will continue with the pharmaceutical companies we know that there must be a broader community awareness effort.

Please join us in contacting the FDA and your elected officials letting them know about the impact this shortage is having on you and your community. An email template that can be used and personalized to send to the FDA and your elected officials is below.

Please feel free to also ask others to join us in our outreach as we know we will be stronger together. Thank you for your efforts to help bring attention to this drug shortage crisis.

For Affected Patients

If you are currently affected by this shortage and unstable please email nurses@tmsforacure.org. Please include your name, the name of your physician who prescribes it, your dose mg/hr, vials/day for CDI and any extras for rescue boluses, your email address and phone number, your pharmacy or infusion company and phone numbers and the statement: “On [month] [day], 2019, I agree to let the TMS nurses share this information with pharmaceutical companies who make IV diphenhydramine.”

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Please send Letters to the FDA and Elected Officials – Templates Below

FDA Template

Please personalize and send the below letter to the FDA Commissioner, Dr. Scott Gottlieb. Please email him at CommissionerFDA@fda.hhs.gov.

Dear Dr. Scott Gottlieb,

As an advocate of The Mastocytosis Society, Inc. and for all patients living with Mast Cell Diseases, I am writing today in regards to the documented FDA Shortage of intravenous and injectable diphenhydramine solution. It is critical that the agency understand how dangerous this shortage is to me and all mast cell disease patients.  

This medication is used during an emergency or as a continuous diphenhydramine infusion (CDI) to prevent and treat life-threatening mast cell attacks which can include anaphylaxis.  

We are asking that you help facilitate the increased production of this product to ensure its availability this year, in 2018.  Additionally, we urge you to consider accessing the drug from safe sources outside the United States until the supply is replenished.

We thank you in advance for your attention to this matter and immediate action towards a solution.  

We know of many patients already in critical care due to this shortage. Without immediate assistance, we face an inevitable and unacceptable loss of life.

Please contact The Mastocytosis Society, Inc.’s Drug Shortage Committee at chairman@tmsforacure.org at your earliest convenience.

Thank you,

Insert name

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Elected Official Template

Please use the template below to personalize and send to your state’s elected officials. 

For a listing of contact information for your senator please visit: https://www.senate.gov/general/contact_information/senators_cfm.cfm

For a listing of contact information for your representative please visit:

https://www.house.gov/representatives

Dear (Insert your elected official)

As an advocate of The Mastocytosis Society, Inc. and for all patients living with Mast Cell Diseases, I am writing today in regards to the documented FDA Shortage of intravenous and injectable diphenhydramine solution. It is critical that you understand how dangerous this shortage is to me and all mast cell disease patients.  

This medication is used during an emergency or as a continuous diphenhydramine infusion (CDI) to prevent and treat life-threatening mast cell attacks which can include anaphylaxis.  

We are asking that you reach out to the FDA and urge them to help facilitate the increased production of this product to ensure its availability this year, in 2018.  Additionally, we ask that you please also urge them to consider accessing the drug from safe sources outside the United States until the supply is replenished.

We thank you in advance for your attention to this matter and immediate action towards a solution.  

We know of many patients already in critical care due to this shortage. Without immediate assistance, we face an inevitable and unacceptable loss of life.

Please contact The Mastocytosis Society, Inc.’s Drug Shortage Committee at chairman@tmsforacure.org at your earliest convenience.

Thank you,

Insert name

07/25/17
RDLA “Rare Disease Legislative Advocates – A Program of the Everylife Foundation for Rare Diseases”

This email blast from RDLA contains Capitol Hill Updates, Community Action Alerts and Policy Resources, and Community Events.

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07/20/17
The BCRA and Healthcare Reform: NORD’s Latest Update

Posted by Paul Melmeyer

A note from Paul Melmeyer, NORD’s Director of Federal Policy, on where healthcare reform stands as of today and how to get involved.

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6/22/17
NORD issues statement regarding the Better Care Reconciliation Act:

National Organization for Rare Disorders, Inc. (NORD)

“Today, the Senate #HealthcareBill was released. After reviewing the discussion draft of the Better Care Reconciliation Act of 2017 (BCRA), NORD finds that it fails to meet several of NORD’s Principles for Healthcare Reform. As the bill is currently written, we are urging both Republican and Democratic Senators to oppose this current draft, and we will continue to lead the rare disease patient community in opposition to this proposal. Read our full statement below.”

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TOP ALLERGY ORGANIZATIONS ISSUE JOINT STATEMENT ON PROPOSED BUDGET

Milwaukee, WI – The following joint statement was released today by the American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI). The AAAAI and ACAAI are gravely concerned about the impact of President Trump’s proposed budget, will have on the future of medical research. We call on Congress to reject the proposed cuts to the National Institutes of Health (NIH) and instead, build on the commitment made last year to begin increasing spending for medical research. The President’s budget blueprint recommends significant, largely unspecified, cuts to the budget of the NIH. In total, the proposed reduction would amount to approximately 20 percent of the NIH’s entire budget. AAAAI President David B. Peden, MD and ACAAI President Stephen A. Tilles, MD said the following upon learning of the proposed cuts: “Although the budget blueprint released by President Trump earlier today is short on specifics, it is hard to imagine how cuts of this magnitude could be accomplished without doing serious harm to the core mission of the NIH – medical research. Together, we call upon Congress to reject any cuts to the NIH that would decrease the NIH’s ability to conduct life-saving medical research and training.” NIH, and in particular the National Institute of Allergy and Infectious Diseases (NIAID), the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Environmental Health Sciences (NIEHS) are providing vital funding for medical research that could lead to life-improving treatments for individuals suffering from allergies, asthma, immunologic disorders and infectious diseases (including HIV/AIDS, emerging and reemerging infectious diseases). Each year, billions of dollars are spent treating the causes and symptoms of food, drug and skin allergy, immunodeficiency, and asthma. Through the work of NIAID, NHLBI, and NIEHS and the research they are funding, we have the opportunity to identify and develop life-saving and life-improving treatments for these widespread chronic conditions. This past October, NIAID researchers announced promising results from an NIH sponsored clinical trial on the efficacy and value of an intervention for treating children and young adults with peanut allergies. This January, an NIAID-sponsored expert panel issued clinical guidelines to help healthcare providers give parents and caregivers important information on the early introduction of peanut-containing foods to infants to prevent the development of peanut allergy. These are the type of results the American people can expect from supporting NIH (NIAID, NHLBI, and NIEHS) and their medical research mission. AAAAI and ACAAI call on Congress to continue its bipartisan support for the NIH and the NIAID, NHLBI, and NIEHS as it completes the 2017 appropriations process and embarks on enacting appropriations bills for the fiscal year 2018. The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals, and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 7,000 members in the United States, Canada, and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

For more information, visit aaaai.org. 

Contact:

Megan Brown

mbrown@aaaai.org

(414) 272-6071