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In February 2008, the FDA issued draft guidance for the pharmaceutical industry when manufacturers give doctors medical journal articles that discuss off-label uses of FDA-approved drugs and medical devices.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.