RACE: Update

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On August 19, 2017 at 5:30 PM, President Trump signed S. 2430 – the FDA Reauthorization Act of 2017 (FDARA) which included the RACE ACT. It is now law!

On 8/03/17, the RACE for Children Act passed in the United States Senate!   It passed the House on 7/12/2017 and was included in the FDA Reauthorization Act (FDARA). This bill includes portions of HR 1231 RACE which will increase development of childhood cancer drugs by updating PREA.

 The bill was made part of S. 2430 – the FDA Reauthorization Act of 2017 and now will move to the President’s desk awaiting his signature to become law.  
Because of all your support, calls, letters, visits to Capitol Hill, and sharing of ideas, we are one step closer to bringing better medicines and treatments to children with cancer.
We are grateful to our champions in Congress:  Senators Michael Bennet and Marco Rubio and Chairman Lamar Alexander and Ranking Democrat Patty Murray in the Senate; and Representatives Michael McCaul and G.K. Butterfield and Chairman Greg Walden and Ranking Democrat Frank Pallone in the House.  This could not have been done without their leadership and commitment and without the extraordinary efforts of their able staff.
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News-1The Naples Daily News wrote the following on July 16, 2017

House passes Rubio bill on childhood cancer

The House gave Florida Sen. Marco Rubio’s efforts to speed up pediatric cancer drugs a major boost Wednesday.

Two months after the Senate passed the Research to Accelerate Cures and Equity for Children Act as part of a measure reauthorizing user fees to fund the Food and Drug Administration, the House did the same — but went an extra step.

The House version includes a key provision the Senate measure does not: making it tougher for the FDA to exempt drug companies from conducting pediatric studies of adult cancer drugs that could prove useful for children. That language was removed from the Senate version after key members of the Senate Health Education and Labor Committee voiced their opposition.

The Senate version, co-sponsored by Colorado Democratic Sen. Michael Bennet, has yet to be approved by the full chamber. It includes several provisions endorsed by childhood cancer advocates, such as:

» Allowing sponsors to meet earlier with the FDA on pediatric studies for drugs for serious or life-threatening diseases.

» Speeding up agreement on pediatric studies by involving the pediatric internal review committee and requiring the FDA to respond to a proposed study in 120 days.

» Making permanent a requirement for the FDA to have neonatology expertise on the Pediatric Advisory Committee.

Once the Senate passes its version of the broader FDA bill, representatives from both chambers can negotiate compromise language to marry both versions so a final measure can be brought back to the House and Senate for approval.

“We are one step closer to developing innovative and promising cancer drugs for children across the country who desperately need them,” Rubio said Wednesday.

The RACE Act was introduced because of what child cancer advocates said was a loophole in the current law.

The Pediatric Research Equity Act that Congress passed in 2003 was supposed to require the pharmaceutical industry to conduct pediatric assessments on drugs developed for adults. But advocates say the law has given the FDA too much latitude in waiving pediatric cancer studies because many of the drugs developed for the four major cancers — breast, prostate, lung and colon — are not childhood cancers.

 


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