The Senate Health Education, Labor & Pensions Committee voted Thursday 5/11/2017 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.
From: the Pensacola News Journal, May 13, 2017: