FDA slammed on clinical trials oversight

Share this article:
The FDA is failing to adequately police clinical trials, according to a report by the inspector general of the Department of Health and Human Services.

HHS IG Dan Levinson said the agency's oversight of clinical trials was disorganized, overly reliant on voluntary compliance and wholly inadequate, with inspections to an estimated 1% of clinical trial sites from 2000-2005. Guidance and regulations, he wrote, do not reflect current clinical trials practices.

HHS OIG recommended: that the agency develop a clinical trial database including all clinical trials, a step mandated under the omnibus FDA overhaul bill signed into law yesterday; the creation of an institutional review board registry, allowing for better inspection of review boards; creation of a cross-center database to facilitate better tracking of inspections; the establishment of a mechanism that ensures better feedback between investigators and agency centers; and new powers allowing inspectors to delve deeper into a clinical trial.

Rep. Rosa DeLauro (D-CT) told The New York Times that the FDA was “passive, they're reactive, and they often side with industry over public health.”
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Channel

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...