The FDA has finalized a rule that will make it easier for pharmaceutical reps to use medical journal articles to promote unapproved uses for medications. Ordinarily, pharmas aren't allowed to advertise products for uses that haven't been formally approved by the FDA. However, the agency has allowed pharma sales reps to distribute articles describing off-label uses if the articles are published in a peer-reviewed medical journal.
The guideline, which comes just days before the Bush administration cedes power to President-elect Obama, has taken fire from some legislators and industry observers, who say it offers the pharmaceutical companies too much leeway.
The pharmaceutical industry, for its part, argues that the guidelines are only reauthorizing a previous policy which had provided useful information to both doctors and patients.
To learn more about the new guidelines:
- read this Modern Healthcare piece (reg. req.)
Related Articles:
Study: Medicaid paid $198 million for unapproved drugs
FDA rules on off-label article distribution issued