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 not a new program. It 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), and Sen. Michael F. Bennet (D-CO), Sen. Marco Rubio (R-FL), Sen. Chris Van Hollen (D-MD), Sen. Cory Gardner (R-CO).
Ask your Senators and Representatives to cosponsor The RACE Act. (It only takes 2 minutes).
Best Pharmaceuticals for Children Act and Pediatric Research Equity Act — Status Report to Congress, Food and Drug Administration, July 2016
The report echoes the main provisions of the RACE for Children Act. Specifically, FDA admitted PREA limitations in encouraging pediatric oncology drug development, such as PREA requirements which involve dependency on the adult indications and exclusion of drugs with orphan indications.
The report said: “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 exactly what the RACE for Children Act does.