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Patient Advocacy 

ACTION ALERT

Support the Selection of “Alopecia Areata” for a Condition-specific Meeting through the Food and Drug Administration’s Patient-Focused Drug Development Initiative

Background

In 2013, the Food and Drug Administration (FDA), with the help of Congress, launched the Patient-Focused Drug Development Initiative (PFDDI). This pilot-program was focused on gathering data related to quality of life issues that individuals face while managing various diseases. FDA placed a premium on gathering feedback directly from affected individuals, particularly feedback on health challenges that are difficult to scientifically quantify, such as depression and anxiety. The ultimate goal of PFDDI is to properly educate FDA decision makers about the patient communities they serve while they are evaluating relevant new therapies. 

FDA is currently deciding which patient communities they will hold PFDDI meetings with during Fiscal Year (FY) 2016 and 2017, and they have nominated “Alopecia Areata” as a condition-area where they would like to learn more about the patient experience. While it is an honor just to be recognized, we can help improve drug development and approval by engaging FDA on this opportunity. In order to be selected for a PFDDI meeting, we need to effectively demonstrate that the alopecia areata community is interested in supporting this effort and that affected individuals are willing to share their personal experiences. We have until Friday, December 5th, to make our case to FDA that “alopecia areata” should be selected for a PFDDI meeting in FY 2016 or 2017. 

webinar computersAction Alert Webinar 

Our friends at Health and Medicine Council of Washington (HMCW) have prepared a useful form which you will use when contacting both your legislators offices and the FDA (see it here). The form is self-explanatory, but I encourage you to listen to this short but informative webinar as Dane Christiansen from HMCW will goes through the form and answers questions.  

Listen to the webinar here>>> (be patient;it may take a while to download)

You can also see Dane's Powerpoint presentation in PDF format here>>.

What You Can Do 

Legislative Liaisons and others who have alopecia areata are being asked to undertake two outreach activities to support the nomination of alopecia areata for a PFDDI meeting.

(IMPORTANT: Please keep copies of whatever you submit to the FDA and/or your Congressperson and email them to either Gary Sherwood or Dane Christiansen.)

1) Submit your own (personal) letter/comments of support to FDA.

A draft outline of a letter is included below to assist with your outreach. Please consider personalizing your letter and then electronically submitting it by going to www.regulations.gov, searching [Docket No. FDA-2012-N-0967], and clicking “comment now”. Please note, while FDA is interested in your personal experience, they expect to share this information and study it (so do not write anything that you would feel uncomfortable circulating).

Personal Letter [Public Comments]

Thank you for once again nominating “alopecia areata” for study through the Patient-Focused Drug Development Initiative (PFDDI) in FY 2016 or FY 2017. Alopecia areata is an autoimmune skin disease that impacts millions of Americans, including children. There are currently no FDA-approved therapies indicated to treat alopecia areata and options for affected individuals are extremely limited. On behalf of the community of individuals impacted by this disease, please select alopecia areata for a PFDDI meeting in FY 2016 or FY 2017. 

[To the extent you feel comfortable, explain your experience with alopecia areata. Focus on emotional impacts and challenges, such as frustration with a lack of treatment options or ineffectiveness of an attempted therapy. Think of this as an opportunity to explain to someone who is unfamiliar with the condition the physical, social, and psychological challenges that might go unnoticed or be overlooked by the general public] 

The alopecia areata community is known for its strength and dedication. If FDA selects this condition for study through the PFDDI, I know there will be a strong and engaged response from affected individuals across the country. We welcome the opportunity to share our experiences with FDA to better inform decision making in this area, and I urge you to select “alopecia areata” for study through the PFDDI in FY 2016 and FY 2017. Thank you. 

2) Ask your legislators in Congress to send a letter of support to FDA.    

You may have already discussed this issue with the Health LAs in the offices of your Members of Congress. Now would be the time to follow up with them and ask for their assistance. Please e-mail these staff members and include the congressional letter below as a draft attachment. Thank them for their work on behalf of the alopecia areata community and inform them they can help by sending the letter to FDA in the very near future. 

Congressional Letter Sample

Margaret Hamburg, M.D.
Commissioner

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg,

I write you today to thank the Food and Drug Administration (FDA) for nominating additional conditions for study through the Patient Focused Drug Development Initiative (PFDDI) in FY 2016 and FY 2017 (Docket No. FDA-2012-N-0967). Since its start in 2013, this programs has demonstrated its importance and value, and I am pleased to see that FDA is continuing to prioritize engaging patient communities to gather critical information on challenging diseases. I hope that FDA will maintain its commitment to PFDDI so that, in time, all conditions of interest can be studied on a systematic basis.  

Further, I wanted to thank FDA for once again nominating “alopecia areata” as a potential condition for study through PFDDI. My constituents have informed me that there are currently no FDA-approved treatment options with an indication for alopecia areata and that current medical interventions are extremely difficult and have limited effectiveness. Alopecia areata has a particularly strong impact children, which FDA may want to evaluate trough patient engagement. Constituents affected by alopecia areata have shared many compelling personal stories with my office by drawing on quality of life issues and the emotional as well as physicals challenges of the disease. I believe FDA will benefit greatly from engaging with these and other alopecia areata patients through PFDDI.

I am pleased with the progress and understanding that has been gained through PFDDI by gathering patient feedback on the challenges of living with conditions such as lung cancer and narcolepsy. It is my hope that similar advancements can be made for the alopecia areata community and patients impacted by other conditions that are also difficult to analyze. Please consider selecting alopecia areata for study through PFDDI during FY 2016 and FY 2017.   

Thank you for your time and your consideration of my request. 

Sincerely,

___________________

Member of Congress

 

Legislative Liaisons Return to Capitol Hill September 2014  

Advocacy Day 2014 Senate Hill Day

Left to Right: Aaron Williams, Lori Jacobi, Lucinda Beaty,Bob Flint, Sarah and Abby Chan, Marianne Peterson, Vicki Kalabokes, Bree Morse, Gary Sherwood, Jeanne Rappoport, Deirdre Nero and Dustin Lee

Hard to believe, but the Alopecia Areata Legislative Liaison program is already two years old and only continues to grow in size and efficacy.  To celebrate its second anniversary, fifteen Legislative Liaisons from 11 states joined NAAF’s retired President & CEO Vicki Kalabokes, Communications Director Gary Sherwood, and Chief Administration Officer Jeanne Rappoport to meet with the health aides of thirty senators and congressional representatives at their offices in Washington, DC in September 2014.  The Legislative Liaisons asked for their lawmakers’ support on advancing alopecia areata research and support in three key areas, all critical components of the Alopecia Areata Treatment Development Program:

  1. Support an allocation of $32 billion for the National Institutes of Health (NIH) in fiscal year 2015 to provide the agency with adequate resources for expanding its alopecia areata portfolio and funding further groundbreaking medical research such as the JAK inhibitor studies at Columbia University which look very promising for the alopecia areata community. 
  2. Create new incentives for industry and promote treatment and diagnostic tool development by cosponsoring H.R. 3116, the MODDERN Cures Act.   
  3. Request the Center for Medicare and Medicaid Services to rewrite current policy to make Medicare benefits available to patients who require cranial prosthetics as a result of alopecia areata.  As it stands now, Medicare only covers cranial hair prosthetics for “secondary alopecia” (i.e. hair loss caused by chemotherapy and other temporary reasons), and excludes alopecia areata.  In the course of our meetings, we learned a California representative may soon be introducing new legislation which would remedy this situation.  Of course, we’ll keep you posted as soon as we hear more. 

Megan Reiter, a liaison who attended with her 8-year-old daughter Mia, says, “We had such an amazing time (Mia still talks about the new friends she made –even though they are “big” and not kids). She is starting to understand how she can help others with the same condition she has – and I’m just proud and happy to be part of an organization that is helping to make a real difference in the lives of the people and families that navigate alopecia areata every day.”

Now approaching its third year, the Legislative Liaisons program is open to anyone in the alopecia areata community who wishes to establish and cultivate relationships with their U.S. representatives and senators in order to educate them about alopecia areata and encourage their support for our legislative objectives. Liaisons are assured, well-informed Americans speaking on behalf of themselves and their 6.5 million fellow citizens who share this disease. If you’re interested in learning more about the Alopecia Areata Legislative Liaison program, or even becoming a liaison yourself, please contact Gary Sherwood at gary@naaf.org or 415-472-3780.  

Learn about the MODDERN Cures Act.

The National Alopecia Areata Foundation is a member of the National Health Council (NHC), the only organization of its kind that brings together all segments of the health care community to provide a united voice for more than 133 million people with chronic diseases and disabilities and their family caregivers.

Made up of more than 100 national health-related organizations, NHC's core membership includes approximately 50 of the national leading patient advocacy organizations, which control its governance. Other members include professional and membership associations, nonprofit organizations with an interest in health, and major pharmaceutical, health insurance, medical device, and biotechnology companies.

Learn more about the National Health Council.

NHC Standards of Excellence


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