Creating Hope for Childhood Cancer
In July, President Barack Obama signed the Creating Hope Act into law. Supporters hope this law will motivate companies to develop drugs for rare pediatric diseases, such as childhood cancers. In the past 30 years, the Food and Drug Administration has approved only one drug for treating childhood cancer.
The Creating Hope Act of 2011 adds rare pediatric diseases to the FDA’s priority review voucher program, which was originally created to incentivize drug companies to produce treatments for neglected tropical diseases, such as malaria or tuberculosis. Under the act, if a company receives FDA approval for creating a treatment for a rare pediatric disease, the company will then receive a priority review voucher that can be used in a future new drug application.
Using the voucher could potentially cut the FDA review process from 10 to six months, thereby allowing a drug to get to market faster and begin earning revenues. The legislation also allows transfer or sale of the voucher to other companies. Advocates of the act say that pharmaceutical companies need a financial incentive to develop pediatric treatments because of the high costs of creating these medications and the difficulty of conducting pediatric clinical trials.
The legislation was sponsored by Reps. Michael McCaul (R-TX) and George Kenneth “G.K.” Butterfield (D-NC).