26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally closed a loophole within a pediatric research law.

The Food and Drug Administration has been emphasizing the need for kids to be included in drug trials since Scott Gottlieb took over as commissioner of the agency in May 2017. The Pediatric Research Equity Act (PREA), passed in 2003, requires drug companies to study some products in children. Drug companies have been skirting the requirement using certain exemptions. The biggest exemption revolves around so-called orphan drugs that treat small patient populations and rare diseases.

The agency gives special incentives to manufacturers—like tax credits and seven extra years of marketing exclusivity—for producing drugs that treat diseases affecting 200,000 or fewer people in the U.S. Drugmakers that create an orphan drug don’t need to conduct research for that drug on paediatric populations. Consequently, drug companies have been designating more and more drugs as orphan drugs in order to skirt the paediatric research responsibility.

Read Bloomberg article