US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion
Neeraj G Patel and colleagues examine how drugs approved through the FDA breakthrough pathway are advertised to consumers and argue that the name contributes to overestimation of benefits In 2012, the US Congress gave the Food and Drug Administration authority to grant “breakthrough therapy” designation to expedite development and regulatory review of new drugs. The designation is used for potential treatments for serious conditions when preliminary evidence suggests they may perform substantially better than available alternatives on “clinically significant endpoints.” Preliminary evi...
Source: bmj.com
