Advancing Hope Act Replaces Creating Hope Act

Advancing Hope Act replaces the expiring Creating Hope Act.
Creating Hope was signed into law by President Obama in 2012 as part of the PDUFA reauthorization, it

expanded the cost-neutral Food and Drug Administration (FDA) priority review voucher (PRV) program, allowing pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare diseases. The bill helped to ease the process of drug development for rare diseases by incentivizing and fast-tracking much-needed pediatric drugs to market. However, the bill only provided three vouchers to be used to expedite treatments for rare diseases through the FDA approval process. The award of the third pediatric voucher for a neuroblastoma drug triggered a little-known sunset clause contained in the 2012 law which authorized the voucher program and will cause the Creating Hope Act to expire on March 17, 2016.

The Advancing Hope Act seeks to remove the three-voucher cap and would clear the way for more therapies to be approved by FDA in an expedited fashion so long as they are used to treat rare diseases. It will also modify the definition of “rare pediatric disease” to include “any form of sickle cell disease” and “any pediatric cancers.”  In addition, this bill  would modify the use of vouchers for tropical diseases.

Two bills have been introduced to improve, strengthen, and replace Creating Hope Act with improved Advancing Hope Act.

George “G.K.” Butterfield Jr. Rep. (NC-01 -D) sponsored HR. 1537: Advancing Hope Act of 2015, Read text : Click Here  The House recently passed HR 6 21st Century Cures Act which contains a reauthorization of Creating Hope, but may not pass in the Senate before Creating Hope expires on March 17, 2016.

    Cohen, Steve [D-TN9]
    Kelly, Mike [R-PA3]
    McCaul, Michael [R-TX10]
    Van Hollen, Chris [D-MD8]
    Bilirakis, Gus [R-FL12]
    Rangel, Charles “Charlie” [D-NY13]
    Cárdenas, Tony [D-CA29]
    Hastings, Alcee [D-FL20]
    Dold, Bob [R-IL10]
    Coffman, Mike [R-CO6]
    (joined as of Sep 25, 2015)

    Isakson, John “Johnny” [R-GA]
    Brown, Sherrod [D-OH]
    Kirk, Mark [R-IL]
    (joined as of Sep 24, 2015)

    Senate Sponsor: Robert “Bob” Casey Jr. (PA-D) S 1878 Advancing Hope Act of 2015, Read text of S. 1878: Click Here

    If your Representative or Senators are not listed above, consider writing them. Tell your Representative and Senators why the Advancing Hope Act is important to you and how it can affect you, your child and the entire childhood cancer community. Tell your story without filters. Tell it like only you can. Make it very personal, enclose a picture of your child. Ask them for action. Ask them to respond to your request.

    You, your friends, and family members writing letters and encouraging others to do so will be very helpful in passing the Advancing Hope Act.


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