Senators Release Plan to Improve Pediatric Device, Drug Safety

Posted 18 April 2012 | By

Sens. Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA) and Pat Roberts (R-KS) introduced new legislation they said will make "critical" improvements in the safety of medical products taken or used by children, reports The Chattanoogan.

The legislation, The Better Pharmaceuticals and Devices for Children Act (BPDCA), aims to address a shortage of information about how pharmaceuticals and medical devices work in children, said Reed.

"This legislation will ensure that drugs and medical devices continue to be tested for use in kids and will provide important information to guide clinical care for children," explained Reed.

"This bill will strengthen successful programs that have helped speed the design of life-saving medical devices for children, and enabled doctors to avoid dangerous guesswork in prescribing medicine for children," added Alexander.

To accomplish this, the proposed legislation would make permanent the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Medical Device Safety and Improvement Act (PMDSA) and the Pediatric Research Equity Act(PREA), all of which currently require regular reauthorization.

The BPDCA would also require pediatric studies to be submitted to FDA by the end of phase 2 clinical trials, mandate the completion of pediatric clinical trials unless FDA waives the requirement, require retroactive public disclosures for all trials going back to 2002 and expand the use of humanitarian exemptions for development, reports The Chattanoogan.

Read more:

The Chattanoogan - Senators Seek To Improve Safety Of Children's Medications And Medical Devices

WDEF - Senator Lamar Alexander a Sponsor of Children's Medications and Medical Devices Bill


Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles