Jenkins defends approvable letters

Share this article:
A recent controversy about the FDA ducking its legal obligation to approve new drugs on time by issuing "approvable" letters is just silly, said FDA director of new drugs John Jenkins. He was also annoyed by the media's slowness to educate themselves.

An “approvable” letter allows the sponsor to submit additional information for FDA consideration, leading some to say the agency is more risk-averse in the wake of the Vioxx withdrawal.

Jenkins said at the Drug Information Association's annual meeting in Philadelphia in June that public comments on these letters “is really a kind of silly way of looking at data and very short-lived numbers.”

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

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 ...