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Drug And Device Makers Must Follow New FDA Guidelines

Posted by Jane Akre
Wednesday, May 27, 2009 1:18 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA, Drug Makers, Device Makers


FDA will take public comment for the next 90 days on new guidelines for drug and device makers to win approval.



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.”  #


Anonymous User
Posted by JILL PAUL RN
Wednesday, May 27, 2009 1:53 PM EST

Jane, this is certainly a small step in the right direction. However, it still does nothing for those innocent victims of faulty medical devices such as the Sprint Fidelis lead and mesh implants. The Medical Device Safety Act S540/HR1346 must be passed in the Senate and Congress to restore the legal rights of citizens harmed by such devices. It is only then that the manufacturers' of such devices will exercise extreme caution when implementing new devices on the market.
If you or a loved one has been injured by a faulty medical device, please sign and post comments on the Medical Device Safety Act Petition which can be found at
We need to stand together to get this very important bill passed in Congress and the Senate to protect you, your Children and your Grandchildren against faulty medical devices.
Thank you.

Posted by Jane Akre
Wednesday, May 27, 2009 4:30 PM EST

Thank you Jill,

You are absolutely right. And something not often mentioned is the enormous cost, not only over the death of a loved one, but of repeated medical procedures to correct the harm done by the defective medical device.

In some cases with mesh victims, hundreds of thousands have been spent to try and remove the mesh, which the FDA now says is permanent.

And that's just on one patient! When we talk about the high cost of medicine and medical reform, a critical component is getting it right the first time on the approval or marketing of these devices.

Thanks for writing!

Anonymous User
Posted by Ruthie
Friday, July 24, 2009 11:28 PM EST

I have been injured by a faulty medical device. I am a part of the faulty TMJ implant disaster. This disaster never should have happen.
We need to protect all americans from faulty medical devices.

Comments for this article are closed.

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