PREA, BPCA Reauthorization Bill Introduced in House of Representatives

Posted 29 March 2012 | By Alexander Gaffney, RAC 

A bipartisan trio of Representatives introduced a bill that would reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), marking an attempt to further a program that has been widely praised for establishing greater safety for pediatric medications.

The bill, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003, was introduced by Reps. Mike Rogers (R-MI), Anna Eschoo (D-CA) and Ed Markey (D-MA).

"These two successful laws have led to 180 new drugs being studies in children, and more than 400 drug labels have been updated with critical pediatric information, leading to more information about pediatric drug safety, effectiveness, dosing and formulations," said Rep. Rogers. "Drug manufacturers, physicians, patients, and the FDA all recognize that BPCA and PREA have worked incredibly well to increase the study of prescription drugs in children. Making both programs permanent provides a more certain regulatory environment for drug makers in pediatric drug research."

According to its sponsors, the bill:

  • provides FDA the necessary enforcement tools to ensure that companies complete their required pediatric studies under PREA on time.
  • increases transparency of the status of pediatric clinical trials required under PREA.
  • ensures the timely submission of a company's "Pediatric Study Plan", a blueprint for how a company plans to study their drug in children.
  • ensures that neonatologists are involved in the process of reviewing and planning pediatric clinical trials.

The bill has already garnered support from a variety of big names, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the American Academy of Pediatrics (AAP).

The bill now moves to the House Energy and Commerce Committee for markup and hearings.

Read more:

BCPA/PREA Reauthorization Bill

GovTrack Bill Tracking

Congressional Press Release

BIO Statement

American Academy of Pediatrics Statement

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