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As the Campaign for Modern Medicines works to fulfill our mission of supporting policies that help bring new, safe medicines to patients in a timely manner and promote innovation in the United States, we are always looking for legislation and policies that uphold our mission. Over the last year, you've seen our work in support of PDUFA reauthorization -- something that will continue this year. When the House Energy and Commerce Committee announced it would be discussing the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA) during the Subcommittee on Health hearing on February 1st that will also focus on the reauthorization of PDUFA, we knew we should go into a little more detail about what PREA/BPCA are, and why the Campaign supports recent efforts in Congress to make them permanent.
For a long time, there were no clinical trials conducted to determine how medicines may affect children because of the expense and difficulty of conducting those trials. This left doctors with no choice but to prescribe medicines which had only been tested and approved for use on adults. In many cases, these medicines react differently in children, who have different physical and mental development. The Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act were passed by Congress to address this issue. The legislation encourages companies to conduct research on safe and effective dosage levels in children, as well as the creation of new medicines specifically for children. The programs have been very successful, and have resulted in the development of nearly 300 innovative medicines for children with cancer, infectious diseases, genetic disorders, and neurological disorders.
Although PREA and BPCA are not directly part of PDUFA, they have historically been taken up by Congress at the same time as PDUFA, and all three are set to expire at the end of September. At the Energy and Commerce Committee's Subcommittee on Health's hearing next Wednesday, members will discuss whether to make PREA and BPCA permanent, or whether to simply reauthorize them for another five years. The European Union has already made similar laws permanent. The United States needs to follow suit in order to stay competitive and give children the best cures and treatments possible.
Because of their great success in advancing pediatric medicine, we support making PREA and BPCA permanent. Both acts fully support the FDA's mission of reviewing and delivering effective, innovative medicines to the patients who need them, regardless of their age, and would promote predictability and consistency at the FDA. Furthermore, we believe these acts don't interfere with FDA's mission. Making PREA and BPCA permanent would also make future PDUFA reauthorizations go more smoothly, since they wouldn't have to be reconsidered at the same time every five years.
We'll be listening for more information on PREA and BPCA during the hearing, and hope you will too.
