New Rules On ‘Off-Label’ Drug Marketing Expected
The FDA is reviewing what kind of data drug companies should be allowed to give doctors about off-label uses with a goal of issuing guidelines by year's end.
The Washington Post: FDA Has Free-Speech, Safety Issues To Weigh In Review Of ‘Off-Label’ Drug Marketing
Prompted in part by recent federal court decisions, the FDA is reviewing its rules on what kind of data drug companies should be allowed to distribute to doctors regarding off-label uses, as well as how they should respond to unsolicited questions from physicians about those uses. Its goal is to issue new guidelines by the end of the year (Dennis, 7/9).
Meanwhile, a doctor quits an FDA safety panel to avoid conflict of interest issues -
The Wall Street Journal: Doctor Quits Uterine-Device Safety Panel Over Conflict
A member of a panel advising the government on the safety of a medical device that can spread cancer in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he accepted from a device manufacturer, the agency said Thursday (Levitz, 7/10).