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PREA loophole that allowed some pharmaceutical companies to avoid pediatric clinical trials sealed by FDA

PREA loophole that allowed some pharmaceutical companies to avoid pediatric clinical trials sealed by FDA

A draft guidance has been finalized by FDA in order to close a loophole in Pediatric Research Equity Act (PREA) which allowed the pharmaceutical companies making medicines for non-orphan diseases in adults. This led to affect more than 200,000 patients to get pediatric subpopulation designation which further exempted the companies from conducting the clinical trials in children that PREA would have normally required.

According to the draft guidance released in December last year, FDA said that “in case of diseases affecting more than 200,000 adults, even if the pediatric population was fewer than 200,000, it would only give orphan designation if the pediatric population constitutes a valid orphan subset or if the company could adequately demonstrate that the pediatric disease was sufficiently different from its adult counterpart”.

The guidance being a part of FDA’s Orphan Drug Modernization Plan announced in June 2017 was finalized with a view to address the inadequate testing of drugs in pediatric populations which has been a priority for the FDA for which the medical community and con gress already made laws to ensure that vulnerable population is not overlooked.

According to FDA commissioner Scott Gottlieb, “Some of the efforts intended to encourage pediatric drug development have been unfortunately used by some drug developers to avoid their obligations to study drugs in pediatric populations. One such area is the longstanding practice of designating pediatric subpopulations of common diseases as orphan conditions.” FDA considers a drug in orphan category if it targets a population of fewer than 200,000 patients or for more common diseases, would leave a drug maker unlikely to recoup the expenses of developing and marketing the drug.”