"There have been a number of legislative efforts to promote new drug development, but frankly, they have not been effective for pediatric cancer drugs," Goodman said.
The previous laws, the Best Pharmaceuticals for Children Act (BTCA) and the Pediatric Research Equity Act (PREA), both deal with encouraging pharmaceutical companies to do clinical trials for their adults drugs on kids to see if there are important pediatric applications of a new drug. The Creating Hope Act however, will allow companies that research and develop a pediatric cancer drug to expedite the FDA review of another drug they are developing.
The idea, explains Adamson, is that selling a pediatric cancer drug is not very lucrative, because a single type of pediatric cancer may only have a few hundred new patients each year, as opposed to, say, a diabetes drug which would have millions. This act would make investing in pediatric cancer research more economically viable by allowing them to get another, more lucrative drug they produce, to market faster.
"Instead of nine months in FDA review, it will happen much faster," says Adamson.