Press Release

PhRMA Statement Regarding Pediatric Reauthorization

PhRMA April 25, 2013

Washington, D.C. (April 18, 2012) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon issued the following statement today:

“PhRMA is pleased to see bipartisan support for the BPCA and PREA Reauthorization Act of 2012 in the House of Representatives and for the Senate’s Better Pharmaceuticals and Devices for Children Act of 2012, both of which would permanently reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

“BPCA and PREA have been exceedingly successful in improving medical care for children by driving research to create innovative medicines for use in pediatric patients. Prior to their passage, roughly 70 percent of medicines taken by children lacked pediatric dosing information. As of 2008, thanks to BPCA and PREA, between 50 percent and 60 percent of medicines have been studied in some part of the pediatric population.

“Permanent reauthorization of BPCA and PREA will help provide biopharmaceutical companies with the certainty that they need to embark on pediatric studies, which can take several years to conduct, with the understanding that the programs will continue throughout the span of the trial. It would allow a more predictable regulatory path and would help spur increased pediatric research, which can improve the quality of care provided to America’s children.

“We look forward to ongoing collaboration with Senator Alexander, Senator Murray, Senator Reed, Senator Roberts, Representative Eshoo, Representative Markey and Representative Rogers on this important legislation, for which we commend them on their bipartisan support.”


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines.

Find PhRMA Online:

For information on how innovative medicines save lives, visit: http://www.innovation.org

For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org

For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org