Senate Passes Pediatric Drug Testing Bill
Pediatricians Support Legislation, Urge House to Take Immediate Action
Washington, DC - Last night, the U.S. Senate unanimously passed legislation endorsed by the American Academy of Pediatrics (AAP) that would require pharmaceutical companies to test new drugs for safety, efficacy and dosing information in children. Most of the medicines currently prescribed to children haven't been tested for their use.
"The Pediatric Research Equity Act" (S.650) restores a 1998 Food and Drug Administration (FDA) regulation known as the "Pediatric Rule" that was struck down by the courts in October 2002. The judge ruled that Congress hadn't given the FDA the authority to carry out such a mandate.
"The Senate gave back what should never have been taken away, the guarantee that the medicines our children take will be rigorously tested," said AAP President E. Stephen Edwards, M.D. "When it comes protecting the health and safety of children, it doesn't get much better than this. We commend Sens. DeWine, Gregg, Kennedy, Clinton and Dodd for their tireless efforts in getting this bill passed."
The Senate legislation makes it clear that the Food and Drug Administration (FDA) has the authority to require pediatric studies and to enforce it with pharmaceutical companies. Additionally, since the "Pediatric Rule" was struck down, the FDA provided information that more than 300 pediatric studies could be lost unless the legislation had a specific effective date provision. Thankfully, S.650 will ensure that no pediatric studies are lost. Companies that made commitments to do pediatric studies under the 1998 Pediatric Rule will need to complete them under this legislation.
Senate Pediatric Drug Bill 2-2-2
The bill covers all new drugs and biologics and certain already marketed products. It would not delay approval of drugs for adult use. It specifically allows pediatric testing to be deferred if waiting for the pediatric studies would delay the availability of the adult product. Studies may also be deferred if studies in adults or older children need to be completed before testing for younger children or infants can be safely conducted.
While the Academy is pleased about the Senate bill passage, the AAP objects to the sunset date it contains, which has the bill expiring in 2007. The Academy believes this should be a permanent program as there's no expiration date on safely testing medicines used in adults.
"The next step is getting the U.S. House of Representatives to introduce the Senate-passed version before the August recess," Dr. Edwards said. "We need to get this legislation passed in Congress now in order to resume critical pediatric drug studies."
S.650 complements the AAP-backed "Best Pharmaceuticals for Children Act," a law that provides financial incentives to drug companies if they voluntarily test medicines frequently prescribed to children. S.650 covers medicines not covered by the "Best Pharmaceuticals" law.
While the Academy believes that congressional action is the quickest way to reinstate the Pediatric Rule, it continues its legal appeal of the October court decision with the Elizabeth Glaser Pediatric AIDS Foundation.
The American Academy of Pediatrics is an organization of 57,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well being of infants, children, adolescents and young adults.
Jeffrey Galinkin, MD
Lynne Maxwell, MD