10:28 AM
Sep 12, 2017
 |  BC Extra  |  Politics & Policy

FDA to close pediatric Orphan loophole

FDA Commissioner Scott Gottlieb Tuesday announced that the agency will close a “loophole” in its implementation of the Orphan Drug Act that drug companies have used to avoid conducting pediatric studies.

“This circumstance arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease,” he said in a blog post.

Drugs that have Orphan Drug status are exempt from requirements under the Pediatric Research Equity Act (PREA) that require sponsors to conduct studies in pediatric indications. “This occurs even in cases where the sponsor never goes on to develop the drug for this...

Read the full 497 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

$35 USD
More Info >