There are almost 900 drugs in the adult cancer pipeline, but only a handful are in development for children. The RACE for Children Act will change that.
Under the RACE for Children Act, companies developing cancer drugs will test the drugs in children with cancer. Pediatric oncologists will be able to study new cancer drugs, with industry funding.
The RACE for Children Act is an update of the Pediatric Research Equity Act (PREA) which requires drug companies to develop their drugs not only for adults, but for children as well. However, PREA has never applied to cancer drugs because children’s cancers occur in different organs than adult cancers.
The RACE for Children Act updates PREA by providing that companies developing cancer drugs would undertake PREA studies of their drugs in children when the molecular target of their drug is relevant to a children’s cancer.
In addition, the RACE for Children Act updates PREA by ending the exemption of PREA obligations for cancer drugs with orphan designations if the molecular target of their drug is relevant to a children’s cancer.
The RACE for Children Act is co-sponsored by:
Rep. Michael T. McCaul (R-TX),
Rep. G. K. Butterfield (D-NC),
Rep. Sean P. Duffy (R-WY),
Rep. Yvette D. Clarke (D-NY),
Rep. Ted Poe (R-TX),
Rep. Markwayne Mullin (R-OK),
Rep. Barbara Comstock (R-VA),
Rep. Zoe Lofgren (D-CA),
Rep. Mike Quigley (D-IL),
Rep. Daniel Lipinski (D-IL),
Rep. James McGovern.(D-MA),
Rep. Blake Farenthold (R-TX),
Rep. Joaquin Castro (D-TX),
Rep. Jim Cooper (D-TN),
Rep. Bobby Rush (D-IL),
Rep. Gus Bilirakis (R-FL),
Rep. Diana DeGette (D-CO),
Rep. Joe Barton, Joe (R-TX),
Rep. Frederica S. Wilson (D-FL),
Rep. James A. Himes (D-CT),
Rep. Mark Pocan (D-WI),
Rep. Alcee L. Hastings (D-FL),
Rep. Grace Meng (D-NY),
Rep. Joyce Beatty (D-OH),
Rep. Daniel M. Donovan, Jr. (R-NY),
Rep. Carol Shea-Porter (D-NH),
Rep. Rodney Davis (R-IL),
Rep. Rick W. Allen (R-GA),
Rep. Peter Welch (D-VT).
Sen. Michael Bennet (D-CO,
Sen. Marco Rubio (R-FL),
Sen. Chris Van Hollen (D-MD),
Sen. Cory Gardner (R-CO).
The RACE for Children Act was amended to the FDA Reauthorization Act, HR 2430.
Thank your Senators and Representatives for sponsoring the RACE for Children Act.
FDA STATUS REPORT TO CONGRESS ON PEDIATRIC DRUG DEVELOPMENT
Best Pharmaceuticals for Children Act and Pediatric Research Equity Act — Status Report to Congress, Food and Drug Administration, July 2016
The report echoes the provisions of the RACE for Children Act. Specifically, FDA noted that PREA does not apply to pediatric oncology drug development.
The report states: “We recommend an amendment of PREA to require certain drugs (including biological products) developed for adult cancer indications to be evaluated for a pediatric cancer indication, when there is evidence the drug affects specific molecular targets and/or molecular mechanisms shared between adult and pediatric cancers. (p.21)”
“We recommend eliminating the exemption under PREA for relevant orphan-designated adult oncology products, found in section 505B(k) of the FD&C Act, which could be useful for pediatric indications. (p.21)”
This is what the RACE for Children Act does.