URGENT - Please take action TODAY - Tell the Senate to include the FAST Rare Disease Language in PDUFA

The Senate’s discussion draft for the Prescription Drug User Fee Act (PDUFA) was released late  Wednesday.  Unfortunately, the rare disease language from the ULTRA/FAST Acts that allows improved  access to the Accelerated Approval process for rare diseases was not included. We need your help to ensure the language will be included in the second draft of PDUFA.   Senators Harkin (D-IA) and Enzi (R-WY), as the Chairman and Ranking Member of the  Senate HELP Committee, have the power to include this important language in PDUFA.   Please take 5 minutes TODAY to call Chairman Harkin’s and Ranking Member Enzi’s offices and  tell them why this is important to you. We will only be successful if YOU take ACTION immediately!  Senators Harkin & Enzi need to  receive hundreds of calls before 5pm EST today from advocates to understand that it is important for  rare disease patients.  YOU can make the difference!  Make your calls and then please share this action  alert via email, Twitter and Facebook. Thank you for you for taking action and for your continued support. _________________________________________________________________________________________ Below are the numbers for Harkin & Enzi’s offices.  Please speak with the staff member who answers the  phone, using the script below.  If no one answers, leave a voicemail.  If the voicemail box is full, call one  of the district offices.  Keep trying until you are sure they received your message.  If you want a direct  response, you should leave your contact information and specifically request a written response.   Be respectful to the staff, but express your urgent concern.   Chairman Harkin (D-IA)  DC Office:  202-224-3254 District Offices: 319-365-4504, 563-322-1338, 515-284-4574, 563-582-2130, 712-252-1550       (if you live in Iowa, please say so on the call) Ranking Member Enzi’s (R-WY) DC Office:   (202) 224-3424      Toll-Free:  (888) 250-1879      District Offices: (307)261-6572, (307)772-2477, (307)527-9444, (307)682-6268, (307)739-9507       (if you live in Wyoming, please say so on the call) Sample Scripts: Parent/Family/Caregiver/Friend:  I am a parent of a child with a rare disease that has no treatment.   I am calling you because I’m concerned that the Senate’s version of PDUFA does not include language  to improve access the Accelerated Approval Pathway for rare diseases.  This language, found in HR 4132  the FAST Act is essential to spur the development of lifesaving treatments for my child.  Please make sure  the rare disease language is included in the final version of PDUFA.  My child will die without treatment. Patient:  I’m calling today because I have a rare disease and I deserve a treatment.  The Senate has failed  to give rare diseases access to the Accelerated Approval pathway in the draft PDUFA language.   The language being circulated is missing essential language from HR 4132 the Faster Access to  Specialized Treatments Act that fixes a catch-22 for rare diseases.  I demand that the Senate listen to the  voices of the patients! Physician/researcher/industry:  I am a physician working to treat rare diseases calling because I’m  concerned that the Senate failed to include language in the PDUFA draft that allows rare diseases to  have access to the Accelerated Approval pathway.  These diseases are so rare that it will be extremely  difficult to ever get this treatment to patients without access to the Accelerated Approval Pathway.   Please include the language from HR 4132 that was included in the House version of PDUFA. Please share how your calls went on our Facebook event page:  http://on.fb.me/TreatmentsNow or  respond to this email letting us know that you took action.  _______________________________________________________________________________________ More information on PDFUA: The Breakthrough Therapies & EXPERRT Acts were included in the Senate’s draft along with the  Accelerated Approval language in TREAT (S.2113).  While this is very important for rare disease patients,  it is not enough.  The language, as it is written in the Senate version does not encourage the FDA to allow  achievable criteria to qualify surrogate endpoints for rare diseases, leaving us with the same limited access  to Accelerated Approval pathway that we have now and does not place any pressure on the FDA to  change the status quo. Currently, the House draft version of PDUFA does include the ULTRA/FAST language that is needed to  spur the development of treatment for rare diseases.  While the Senate does not include our language,  the discussion draft is not final; we still have time to influence the Senate’s language.  We must have  our language in both the House & Senate versions of PDUFA or we risk having our language debated  in Conference Committee where we have little influence and anything could happen.  In order to be  successful, we must continue to promote HR 4132 the Faster Access to Specialized Treatments that  includes the ULTRA language in both the House & the Senate. Draft Senate PDUFA Language Draft House PDUFA Language Redline comparing the Senate's PDUFA draft to FAST Read the FAST Act Blog about the grassroots movement behind ULTRA/FAST Chart showing how initiatives get into PDUFA Sincerely, Matthew Alsante Executive Director

Address postal inquiries to:

Sarcoma Foundation of America

9899 Main Street, Suite 204

Damascus, MD 20872

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Give a Gift, Help Save a Life

Not Sure What to Give for the Holidays?

Consider a donation to SFA Texas!

Why waste your money getting someone a gift they will never use or never wear?


Give the gift of your time to create long-lasting memories and show loved ones you care, then use the money you saved to make a (tax-deductible) donation in their honor to help cure cancer in our time.


'Tis the season for giving. Now open your heart, and give to a cause that can really save lives.


Also, as you get your new gifts of technology this holiday season, send your old, outdated technology to Gazelle and turn it into a donation to SFA Texas at no extra cost to you!


Merry Christmas and Happy Holiday!

Happy Birthday Sarah

Want to honor Sarah on her birthday?

Donate to SFA Texas by clicking here.

Sarah's birthday is on October 19. She would be turning 29 years old this year. Donating to SFA Texas to help achieve her named grant would be such a wonderful way to honor her on this special day.

Your donation will not only help Sarah's name live on, but also support Sarcoma research to help put an end to this cruel disease. Happy birthday, Sarah. Every time I eat a persimmon I think of you since you introduced me to them on your last birthday. :)
You are deeply missed.

Ways to Donate

Want to donate to SFA Texas and the Sarah Chidgey Hughes fund but aren't sure how? There are several ways:

1. Donate online. Click here for our online donation page. The "event" box is already checked and filled in with "Sarah Chidgey Hughes Fund", so all you need to do is select how much you'd like to donate, and fill in your information!

2. Write a check. Make checks payable to "Sarcoma Foundation of America- TX" and in the memo line write "Sarah Chidgey Hughes" so we know the money is meant for her named research grant. Mail checks or cash to:

Bryan Brooks
2727 Allen Parkway
Ste. 1850
Houston, TX 77019

3. Donate used electronics. Click here (or on the Gazelle link on the right sidebar) for our used electronics donation page. If you have any old electronics lying around taking up space, turn them into a monetary donation and feel good that you used it for charity rather than throwing it out or letting it junk up a drawer. I just donated a used cell phone and it was so simple!


Any questions? We are more than happy to answer them. Just leave a comment or send us an email at bbrooks@gmail.com

Remember, no donation is too small or too large. If 5,000 people donated $10, we'd be at our goal! 5,000 people isn't that many when you consider how HUGE Texas is! Let's work together and make this happen! As always, your donations and support are so appreciated. Thank you!

Texas Chapter Vision

Hi!

For those of you all over Texas who are already members of SFA, and for those of you who are just now joining, I'd like to get us all on the same page.

Until now, there was not an official Texas chapter, so SFA members who happened to reside in Texas held their own fundraisers to honor their loved ones. We've heard of some fundraising efforts around the state such as this one in memory of the beloved Sheri Eke, and I'm sure there are many others going on as well. We would like to support all who have been touched by Sarcoma here in the Lone Star State.

Our vision for the Texas chapter is to have a unified effort in raising awareness and fundraising to help find a cure in our time. We have chosen to begin with raising money in memory of Sarah Chidgey Hughes. Once we reach this goal, our hope is to select another person to honor in a similar way. Texas is a very large state, so let's work together to make a difference!

We are in transition at the moment, but hopefully as we reach out to those across Texas we will combine forces and work together as a team. We have until February 2012 to reach our goal of a named research grant in memory of Sarah Chidgey Hughes.

If you would like to recommend someone to be the focus of our next fundraising effort or if you have any ideas on how we could improve our efforts in reaching out and unifying our goals, please contact us via email or by commenting on this post.

Together we can do great things!

SFA Texas Promotional Flyer

Hi friends!

Below you will find a promotional flyer to help us spread the word about our wonderful cause. Simply download the flyer, print it out, cut it in half, and voila! You now have two flyers to post wherever your heart desires! Allow me to suggest some places you might consider posting them:

• Office break rooms
• Church message boards
• College campuses
• Coffee Shops & restaurants

Where will you post your flyers? Feel free to share your ideas in the comments!

SFA Promotional Flyer PDF

Happy posting!

Blue Planet Cafe

We are proud to announce that the Sarcoma Foundation of America- Texas Chapter is the September charity of the month at Blue Planet Cafe in Houston!

Blue Planet Cafe: 1330 Wirt Road, Houston
Mon-Thur 7:30am-8pm
Fri 7:30am-9pm
Sat 9am-9pm
Sun closed

In addition to allowing us to share information about our chapter, we will also have a donation box available there. Did I mention the staff is very friendly and the food is delicious?! Stop by, grab a bite, and consider a donation to the SFA! Even if you just toss your spare change into our box...every little bit helps! You've got to eat, so why not support a local business and help our charity while you do it?!

Bon Appetit!