From the Pensacola News Journal, May 13, 2017: A Senate panel Thursday gave a thumbs up to several elements of a bill co-sponsored by Florida Republican Marco Rubio to speed up child cancer drugs but stopped short of approving a key provision that advocates have long sought.
The Senate Health Education, Labor & Pensions Committee voted Wednesday to include aspects of the Research to Accelerate Cures and Equity for Children Act (RACE) as part of a measure reauthorizing the Food and Drug Administration.
•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.
•Requiring the FDA to work with public and private stakeholders to develop guidance on how molecular targets can be used to develop pediatric cancer drugs.
The meat of the bill – making it tougher for the FDA to exempt drug companies from conducting pediatric studies of adult cancer drugs that could prove useful for children – was left out. But Rubio and the other chief co-sponsor, Colorado Democrat Michael Bennet, plan to try amending the bill when it hits the Senate floor.
“With new and promising advancements in medical research, researchers have the opportunity to do more to help children in their fight against cancer, but first we must update our laws to ensure they are fully leveraging the latest medical innovations and techniques to find better treatments and cures,” Rubio said after the vote.
Congress passed the Pediatric Research Equity Act in 2003 to help address the issue. 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.
The FDA routinely exempts drug companies from testing children even though some experts believe molecular-level studies on those adult cancers could lead to pediatric breakthroughs, according to the Alliance for Childhood Cancer, an advocacy group.
“The practical consequence of these exemptions is that no drugs have been assessed in children as a result of PREA,” the alliance wrote in a letter last month to the top lawmakers of key House and Senate committees. “We believe it is critical that the needs of children suffering from cancer, now and in the years to come are addressed as part of this legislation.”
Stay tuned for a new strategy to be announced soon
Below is the promotion we used before the RACE for Children Act was to be marked up by the HELP Committee. That meeting has been completed (see above)
Senate Committee for Health, Education, Labor, & Pensions (HELP) will meet this Wednesday, 5/10/17, to consider S. 456, RACE for Children Act for passage. Here are 2 easy ways you can help influence the HELP Committee.
One: Contact Senators Alexander and Murray’s offices and request them to support and vote for S. 456 The RACE for Children Act using this short and to the point sample message. Make it personal, tell about your child also.
Please pass S. 456 RACE for Children Act. There have been hundreds of novel cancer drugs developed for adults while, in the last fifty years, our children have only had three developed for them. Our children also deserve the most promising drugs to fight cancer. Please update the old, ineffective PREA law and have it catch up to today’s science.
Senator Lamar Alexander, Chair, Senate HELP Committee CLICK HERE
Senator Patty Murray, Ranking Member, Senate HELP Committee. CLICK HERE
Two: Call Senator Alexander and Senator Murray.
Senator Lamar Alexander (202) 224-4944 Senator PattyMurray (202) 224-2621
Tell your personal reason why RACE4ChildrenAct and childhood cancer drug development is important to you. Here are some other reasons why we should RACE for Children. It’s about time for the Senate to HELP.
RACE for Children Act provides that companies developing cancer drugs should test their drugs in children with cancer. Specifically, pursuant to the RACE Act, if a cancer drug is developed for a molecular target that is relevant in a pediatric cancer, then that drug should be studied in the pediatric cancer as well.
RACE does not cost the taxpayers anything.