New laws and regulatory pressure have advanced research on pharmaceuticals for pediatric patients, which have typically waited behind adults on the industry's list of development priorities. As Bloomberg made clear, FDA advisers meet today with trialing several drugs for childhood cancers at the top of their agenda.
The advisers plan to scrutinize the development paths for cancer drugs from GlaxoSmithKline ($GSK), Amgen ($AMGN), Boehringer Ingelheim and Threshold Pharmaceuticals ($THLD) in younger patients. The meeting comes as advocates push for the FDA to become more active in considering pediatric drug development and ahead of the January 2013 effective date of a law that requires industry to get rolling earlier with research on cancer drugs for pediatric patients, Bloomberg reported.
Lawmakers and regulators have taken steps to make sure pediatric patients don't get left behind. The economics of cancer drug development favor trials for adults because there are much larger markets for meds against adult cancers. As Bloomberg reports, drugmakers must keep pediatric patients on their radar and trial drugs for diseases that afflict kids. In oncology, those cancers include solid tumors and blood malignancies.
As we've heard all week, the economics of drug R&D have worsened over recent years and decades, and drugmakers have tried in vain to improve their returns on the money spent on research. Yet the pediatric requirements come with a notable perk, as drugmakers can gain an added 6 months of market exclusivity for their products. For a blockbuster, the extended exclusivity could mean hundreds of millions or even billions of dollars in revenue that might otherwise be lost to generic competition.
"Pediatric legislation, including a combination of incentives and requirements, has significantly increased pediatric drug research and development and led to a substantial increase in products with new pediatric information in labeling," an FDA staff report says, as cited by Bloomberg.
- check out the Bloomberg article