FDA to Study DTC Ads for Drugs Approved Under Accelerated Process

As Eli Lilly’s decision to pull a cancer treatment from the market two weeks ago shows, drugs approved under the US Food and Drug Administration’s (FDA) accelerated approval pathway may not always live up to early promising data.

And though failing to verify clinical benefit is rare for an accelerated approval product, FDA explained Tuesday in the Federal Register, the agency is interested in finding out more about how companies that win accelerated approvals advertise their products directly to consumers because such advertisements can be misleading.