Dear Supporters of HopeNOWforALS.org (HNFA), Two important notices in this update: 1) Call to Action (details below) 2) Last update for this petition. HNFA will be issuing a NEW PETITION that focuses on our current goals. Watch for it in your email: “Terminally Ill Patients Denied Treatment” and please sign it right away to continue receiving updates. We continue to make progress in our negotiations with the FDA for smarter, faster, and more humane clinical trials. The FDA has expressed support for the study design proposed by HNFA and we are now scheduling meetings with researchers and drug companies to expedite its implementation. However, we have also learned the FDA will not utilize the 1992 Accelerated Approval Program (AAP) due to a technicality called “surrogate endpoints”. This strict interpretation of AAP is closing the door to fatal diseases like ALS which do not have a verified “surrogate endpoint”. ALS treatments need AAP, a “conditional approval” that allows PALS access to promising treatments after a Phase 2 trial. http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm Please take a few minutes and write to your congress person using the sample letter below. We've also listed all the representatives below to make it easier for you. Thank you for your courage and continuing to fight for the lives of those battling this cruel disease. Together we are creating positive change that will give PALS Hope Now. Please remember to sign our next petition: “Terminally Ill Denied Treatment” Nick, Jehad, Eric, and Linda (cofounders of HNFA) CALL TO ACTION: Congress is back in session and it’s time to remind them this fight isn’t over. Please send the following message to members of Congress and copy your media contacts: ------ Honorable [member of Congress], Your terminally ill constituents need your help. HopeNowforALS.org has learned in its FDA meetings that the FDA will not utilize the Accelerated Approval Program (AAP) for ALS based on a little-known technicality called "surrogate endpoints". With a fast moving fatal disease there is no need for surrogate endpoints to measure the statistical effects of a therapy. Real clinical endpoints (manifestations of the disease) can be used due to the swift progression of ALS. The FDA’s strict interpretation of the 1992 AAP produces unintended and dire consequences to those with an imminent death sentence. The FDA has granted AAP for the treatment of cancers, HIV, and made ZMAPP available for Ebola patients - but rejects the same consideration for treatments aimed at ALS and other fatal diseases. Right to Try (RTT) laws are being passed in state after state, but without new federal legislation there is no guarantee terminally ill patients will have access to safe and promising therapies that are still in clinical trials.The FDA likes to tout "Expanded Access" (EAP or compassionate use) as the solution, but “Expanded Access” has many barriers. Only a few people with significant education, wealth, and medical resources are likely to realize any benefit from EAP. Furthermore, drug developers are often unwilling to provide the treatment for a host of reasons: • risks to future FDA approval, • inadequate resources to manufacture and distribute the drug free of charge, or • a desire to shelter the true manufacturing cost to avoid jeopardizing future market value. HopeNowforALS.org has conducted four meetings since May 12, 2015 with Janet Woodcock and other senior staff at the FDA. We are focused on two objectives: • Establishing a pathway for accelerated approval (AAP) for all safe and promising therapies for ALS, and • Modernizing the clinical trial process bringing it into the 21st century. California is poised to become the 25th State to adopt Right to Try (RTT) legislation. It's a step in the right direction but - we need Congress to enact new legislation that ensures terminally ill patients will have genuine access. AAP is a "conditional approval" that allows the FDA to withdraw approval if the treatment fails to perform as expected. We strongly urge Congress to: 1. Modify the FDA's authorizing laws to require that all expedited drug development tools, including AAP - with or without "surrogate endpoints," are utilized for fatal diseases, and 2. Make it clear to the FDA that terms like "expedited" and "accelerated" do in fact mean what they imply - speed. [Your name and contact info] ---------- US SENATORS Alabama Sessions, Jeff - (R - AL) (202) 224-4124 http://www.sessions.senate.gov/public/index.cfm/contact-jeff Shelby, Richard C. - (R - AL) (202) 224-5744 http://www.shelby.senate.gov/public/index.cfm/emailsenatorshelby Alaska Murkowski, Lisa - (R - AK) 202) 224-6665 http://www.murkowski.senate.gov/public/index.cfm/emaillisa Sullivan, Daniel - (R - AK) (202) 224-3004 http://www.sullivan.senate.gov/content/contact-dan Arizona Flake, Jeff - (R - AZ) (202) 224-4521 http://www.flake.senate.gov/public/index.cfm/contact-jeff McCain, John - (R - AZ) (202) 224-2235 http://www.mccain.senate.gov/public/index.cfm/contact-form Arkansas Boozman, John - (R - AR) (202) 224-4843 http://www.boozman.senate.gov/public/index.cfm/e-mail-me Cotton, Tom - (R - AR) 202) 224-2353 http://www.cotton.senate.gov/content/contact-tom California Boxer, Barbara - (D - CA) (202) 224-3553 https://www.boxer.senate.gov/contact/shareyourviews.html Feinstein, Dianne - (D - CA) (202) 224-3841 https://www.feinstein.senate.gov/public/index.cfm/e-mail-me Colorado Bennet, Michael F. - (D - CO) (202) 224-5852 http://www.bennet.senate.gov/?p=contact Gardner, Cory - (R - CO) (202) 224-5941 http://www.gardner.senate.gov/content/contact-cory Connecticut Blumenthal, Richard - (D - CT) (202) 224-2823 https://www.blumenthal.senate.gov/contact Murphy, Christopher - (D - CT) (202) 224-4041 http://www.murphy.senate.gov/contact Delaware Carper, Thomas R. - (D - DE) (202) 224-2441 http://www.carper.senate.gov/public/index.cfm/email-senator-carper Coons, Christopher A. - (D - DE) (202) 224-5042 http://www.coons.senate.gov/contact/ Florida Nelson, Bill - (D - FL) (202) 224-5274 http://www.billnelson.senate.gov/contact-bill Rubio, Marco - (R - FL) (202) 224-3041 http://www.rubio.senate.gov/public/index.cfm/email-senator-rubio?p=Contact Georgia Isakson, Johnny - (R - GA) (202) 224-3643 http://www.isakson.senate.gov/public/index.cfm/email-me Perdue, David - (R - GA) (202) 224-3521 http://www.perdue.senate.gov/content/contact-david Hawaii Hirono, Mazie K. - (D - HI) (202) 224-6361 http://www.hirono.senate.gov/contact/email Schatz, Brian - (D - HI) (202) 224-3934 http://www.schatz.senate.gov/contact Idaho Crapo, Mike - (R - ID) (202) 224-6142 http://www.crapo.senate.gov/contact/email.cfm Risch, James E. - (R - ID) (202) 224-2752 http://www.risch.senate.gov/public/index.cfm/email Illinois Durbin, Richard J. - (D - IL) (202) 224-2152 http://www.durbin.senate.gov/contact/email Kirk, Mark - (R - IL) (202) 224-2854 http://www.kirk.senate.gov/?p=comment_on_legislation Indiana Coats, Daniel - (R - IN) (202) 224-5623 http://www.coats.senate.gov/contact/ Donnelly, Joe - (D - IN) (202) 224-4814 http://www.donnelly.senate.gov/contact/email-joe Iowa Ernst, Joni - (R - IA) (202) 224-3254 http://www.ernst.senate.gov/content/contact-joni Grassley, Chuck - (R - IA) (202) 224-3744 http://www.grassley.senate.gov/constituents/questions-and-comments Kansas Moran, Jerry - (R - KS) (202) 224-6521 http://www.moran.senate.gov/public/index.cfm/e-mail-jerry Roberts, Pat - (R - KS) (202) 224-4774 http://www.roberts.senate.gov/public/index.cfm?p=EmailPat Kentucky McConnell, Mitch - (R - KY) (202) 224-2541 http://www.mcconnell.senate.gov/public/index.cfm?p=ContactForm Paul, Rand - (R - KY) (202) 224-4343 http://www.paul.senate.gov/?p=contact Louisiana Cassidy, Bill - (R - LA) (202) 224-5824 http://www.cassidy.senate.gov/content/contact-bill Vitter, David - (R - LA) (202) 224-4623 http://www.vitter.senate.gov/contact/email-senator-vitter Maine Collins, Susan M. - (R - ME) (202) 224-2523 http://www.collins.senate.gov/public/index.cfm/email King, Angus S., Jr. - (I - ME) (202) 224-5344 http://www.king.senate.gov/contact Maryland Cardin, Benjamin L. - (D - MD) (202) 224-4524 http://www.cardin.senate.gov/contact/ Mikulski, Barbara A. - (D - MD) (202) 224-4654 http://www.mikulski.senate.gov/contact Massachusetts Markey, Edward J. - (D - MA) (202) 224-2742 http://www.markey.senate.gov/contact Warren, Elizabeth - (D - MA) (202) 224-4543 http://www.warren.senate.gov/?p=email_senator Michigan Peters, Gary - (D - MI) (202) 224-6221 http://www.peters.senate.gov/content/contact-gary Stabenow, Debbie - (D - MI) (202) 224-4822 http://www.stabenow.senate.gov/?p=contact Minnesota Franken, Al - (D - MN) (202) 224-5641 http://www.franken.senate.gov/?p=email_al Klobuchar, Amy - (D - MN) (202) 224-3244 http://www.klobuchar.senate.gov/public/email-amy Mississippi Cochran, Thad - (R - MS) (202) 224-5054 http://www.cochran.senate.gov/public/index.cfm/email-me Wicker, Roger F. - (R - MS) (202) 224-6253 http://www.wicker.senate.gov/public/index.cfm/contact Missouri Blunt, Roy - (R - MO) (202) 224-5721 http://www.blunt.senate.gov/public/index.cfm/contact-roy McCaskill, Claire - (D - MO) (202) 224-6154 http://www.mccaskill.senate.gov/contact Montana Daines, Steve - (R - MT) (202) 224-2651 http://www.daines.senate.gov/content/contact-steve Tester, Jon - (D - MT) (202) 224-2644 http://www.tester.senate.gov/?p=email_senator Nebraska Fischer, Deb - (R - NE) (202) 224-6551 http://www.fischer.senate.gov/public/?p=email-deb Sasse, Ben - (R - NE) (202) 224-4224 http://www.sasse.senate.gov/content/contact-ben Nevada Heller, Dean - (R - NV) (202) 224-6244 http://www.heller.senate.gov/public/index.cfm/contact-form Reid, Harry - (D - NV) (202) 224-3542 http://www.reid.senate.gov/contact New Hampshire Ayotte, Kelly - (R - NH) (202) 224-3324 http://www.ayotte.senate.gov/?p=contact Shaheen, Jeanne - (D - NH) (202) 224-2841 http://www.shaheen.senate.gov/contact/ New Jersey Booker, Cory A. - (D - NJ) (202) 224-3224 http://www.booker.senate.gov/?p=contact Menendez, Robert - (D - NJ) (202) 224-4744 http://www.menendez.senate.gov/contact New Mexico Heinrich, Martin - (D - NM) (202) 224-5521 http://www.heinrich.senate.gov/contact/write-martin Udall, Tom - (D - NM) (202) 224-6621 http://www.tomudall.senate.gov/?p=contact New York Gillibrand, Kirsten E. - (D - NY) (202) 224-4451 http://www.gillibrand.senate.gov/contact/ Schumer, Charles E. - (D - NY) (202) 224-6542 http://www.schumer.senate.gov/contact/email-chuck North Carolina Burr, Richard - (R - NC) (202) 224-3154 http://www.burr.senate.gov/public/index.cfm?FuseAction=Contact.ContactForm Tillis, Thom - (R - NC) (202) 224-6342 http://www.tillis.senate.gov/content/contact-thom North Dakota Heitkamp, Heidi - (D - ND) (202) 224-2043 http://www.heitkamp.senate.gov/public/index.cfm/email-heidi Hoeven, John - (R - ND) (202) 224-2551 http://www.hoeven.senate.gov/public/index.cfm/email-the-senator Ohio Brown, Sherrod - (D - OH) (202) 224-2315 http://www.brown.senate.gov/contact Portman, Rob - (R - OH) (202) 224-3353 https://www.portman.senate.gov/public/index.cfm/contact-form Oklahoma Inhofe, James M. - (R - OK) (202) 224-4721 http://www.inhofe.senate.gov/contact Lankford, James - (R - OK) (202) 224-5754 http://www.lankford.senate.gov/content/contact-james Oregon Merkley, Jeff - (D - OR) (202) 224-3753 http://www.merkley.senate.gov/contact Wyden, Ron - (D - OR) (202) 224-5244 http://www.wyden.senate.gov/contact Pennsylvania Casey, Robert P., Jr. - (D - PA) (202) 224-6324 http://www.casey.senate.gov/contact Toomey, Patrick J. - (R - PA) (202) 224-4254 http://www.toomey.senate.gov/?p=contact Rhode Island Reed, Jack - (D - RI) (202) 224-4642 http://www.reed.senate.gov/contact/email Whitehouse, Sheldon - (D - RI) (202) 224-2921 http://www.whitehouse.senate.gov/contact/ South Carolina Graham, Lindsey - (R - SC) (202) 224-5972 http://www.lgraham.senate.gov/public/index.cfm?FuseAction=Contact.EmailSenatorGraham Scott, Tim - (R - SC) (202) 224-6121 http://www.scott.senate.gov/contact/email-me South Dakota Rounds, Mike - (R - SD) (202) 224-5842 http://www.rounds.senate.gov/content/contact-mike Thune, John - (R - SD) (202) 224-2321 http://www.thune.senate.gov/public/index.cfm/contact Tennessee Alexander, Lamar - (R - TN) (202) 224-4944 http://www.alexander.senate.gov/public/index.cfm/email Corker, Bob - (R - TN) (202) 224-3344 http://www.corker.senate.gov/public/index.cfm/emailme Texas Cornyn, John - (R - TX) (202) 224-2934 http://www.cornyn.senate.gov/public/index.cfm?p=ContactForm Cruz, Ted - (R - TX) (202) 224-5922 http://www.cruz.senate.gov/?p=email_senator Utah Hatch, Orrin G. - (R - UT) (202) 224-5251 http://www.hatch.senate.gov/public/index.cfm/email-orrin Lee, Mike - (R - UT) (202) 224-5444 http://www.lee.senate.gov/public/index.cfm/contact Vermont Leahy, Patrick J. - (D - VT) (202) 224-4242 https://www.leahy.senate.gov/contact/ Sanders, Bernard - (I - VT) (202) 224-5141 http://www.sanders.senate.gov/contact/comment Virgina Kaine, Tim - (D - VA) (202) 224-4024 https://www.kaine.senate.gov/contact Warner, Mark R. - (D - VA) (202) 224-2023 http://www.warner.senate.gov/public/index.cfm?p=ContactPage Washington Cantwell, Maria - (D - WA) (202) 224-3441 http://www.cantwell.senate.gov/public/index.cfm/email-maria Murray, Patty - (D - WA) (202) 224-2621 http://www.murray.senate.gov/public/index.cfm/contactme West Virginia Capito, Shelley Moore - (R - WV) (202) 224-6472 http://www.capito.senate.gov/content/contact-shelley Manchin, Joe, III - (D - WV) (202) 224-3954 http://www.manchin.senate.gov/public/index.cfm/contact-form Wisconsin Baldwin, Tammy - (D - WI) (202) 224-5653 http://www.baldwin.senate.gov/contact Johnson, Ron - (R - WI) (202) 224-5323 http://www.ronjohnson.senate.gov/public/index.cfm/email-the-senator Wyoming Barrasso, John - (R - WY) (202) 224-6441 http://www.barrasso.senate.gov/public/index.cfm/contact-form Enzi, Michael B. - (R - WY) (202) 224-3424 http://www.enzi.senate.gov