Have an opinion on off-label drug use information? Take this survey! Posted by Daniela at 03/06/08 05:03 PM

John Mack, editor of Pharma Marketing News and owner of Pharma Marketing Blog, has a survey about whether drug companies should hand out off-label drug studies to doctors. I went here to take the survey and found surprising results. Since this publication reaches mainly the pharmaceutical industry, why not tell them what you think?

In February 2008, the FDA issued draft guidance for the pharmaceutical industry when manufacturers give doctors medical journal articles that discuss off-label uses of FDA-approved drugs and medical devices. The agency says “okay,” as long as the articles came from peer-reviewed journals with expert editorial boards. The articles would contain a statement that the described off-label uses haven’t been cleared or approved by the FDA. They advise against distributing articles not supported by “credible medical evidence.”

Under the proposed rule, the agency will no longer require drug and device manufacturers to submit the studies to the agency beforehand or an intent to submit an application for FDA approval of the off-label use (i.e. perform clinical trials).

The FDA is accepting public comments on this issue until April, and you can go here for their contact information and reference number.

comments (8)

1 Posted by John Braun at 03/07/08 08:29 PM

I worked in mental health for 20 years with long term chronic adults suffering with schizophrenia, bipolar disorder, etc. I had almost daily interactions with our psychiatrists.

Our psychiatrists used many medications in "off-label" situations; many times with great success. In my 20 years, I never saw a patient experience adverse affects due to off-label use, most of the time positive results were obtained; else the medication was discontinued. In every case, the medication was explained to the patient along with expectations and desired results, side effects, and possible adverse effects - before the prescription was written. No medications were prescribed (label or off-label use) without informed consent - ever.

Medical doctors receive years and years of training. After that, they learn their day to day trade in peer supervised environments as they gain real world experience. I was (and remain) extremely confident that the physicians I worked with could make knowledgeable decisions about medications both in labeled and in off-labeled use.

I would not hesitate to take any medication my personal physician prescribed to me as long as a reasonable explanation was given to me. I feel the FDA is but one cog in a huge wheel when it comes to our medical care. Trained physicians, peer review, medical journals, drug reps, etc. make up many other cogs in that wheel - each are as important as the other. Word of mouth in the medical field (re; medication uses) appear to be as reliable as the FDA.

2 Posted by herbert at 03/11/08 09:30 AM

I do not listen to commercials. I turn the sound down, but I do not believe medicine should be advertised. I would consider myself if I told a medical doctor who is treating me what medicine I should take. The is reason for consulting a health professional is to allow them to diagnose what care and or medicines should be taken. If I knew anything about medicine, I would not have to consult a health professional. Hence when I meet with my doctor, I tell him the symptons as best I can describe and allow him to examine me and then make a decision on what needs to be done.

3 Posted by Ambulance Doctor at 05/16/08 06:07 AM

It's pity I was late with the comments.

4 Posted by Drug Rehab at 06/13/08 10:39 AM

As I said in some of my previous posts, someday soon we will be able to see on the market drugs that offer immorality and will be FDA approved...

5 Posted by Drug Rehab at 06/14/08 12:49 AM

I have a question... They accept public comments, but do they actually take those comments in consideration?

6 Posted by Pharmacy at 07/29/08 11:37 PM

Great...I love this post, I got more info here, Thanks.Really happy to read this

7 Posted by james blake at 09/19/08 03:33 PM

Many interesting things are revealed by this article to the world.How can Drugs use or manufacturing can be implemented without the FDA?
then what's the use of maintaining FDA and other ones.Is it for just namesake purpose?Need to act immediately by the government in this case.......

8 Posted by kylesanders at 02/12/09 04:26 PM

Its safe to say that drugs cause enough problems in our world. I'm not very confident in the FDA's ability to regulate drug testing let alone individual doctors. These drug reps wine and dine doctors to push there drug, so I cant help but fell there a little bias when it comes to handing out pills. At the same time I have to believe that some doctors are in it for the benefit of mankind. But I'm not sure that its a good idea to give more access to doctors to test more drugs on the populace.

Kyle