Drug And Device Makers Must Follow New FDA Guidelines

Drug and medical device makers hoping to win quick approval from federal regulators have some new guidelines to note. 

Posted on the Food and Drug Administration’s Web site Tuesday, the guidelines aren’t binding, reports the Wall Street Journal, but will help avert the usual pitfalls to approval generally due to omitting or minimizing important risk information.

For example, a need for “certain monitoring” - a generalized reference, should be replaced with language that states clearly a product requires monthly blood tests for liver damage, the FDA guidelines say. 

And for advertisements, the FDA will be reviewing the “net impression” to determine if the information imparted is accurate. 

Smiling people, changing camera angles, and upbeat music may obscure the more serious message of the potential for harm, which the FDA could consider as an overall misleading impression. 

For example, last year, at a congressional hearing a Schering-Plough Corp (SGP.N) an ad for allergy drug, Nasonex, drew criticism for featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained, reports Reuters.

The FDA will take public comment for 90 days before issuing new guidelines.  

With Dr. Margaret Hamburg and Dr. Joshua Sharfstein now at the helm of the FDA, more changes are expected to overhaul an agency with an increasing responsibility to review a quarter of all consumer products including food, medical devices and drugs. 

Dr. Ray Woosley, president of a nonprofit that works to improve the drug approval process tells Bloomberg, “The “The FDA is a public health agency and to have two public health leaders at the helm is a clear signal of the right direction for the agency.”  #