FDA Proposes Giving Up On Policing Off-Label Drug Promotion

This NY Times article nicely summarizes the issues. Basically, the draft guidance merely recognizes what actually happens in the marketplace; drug companies promote unapproved uses and physicians prescribe the drugs "off-label."

Who can serve as the "trusted advisor" for the patient?

• Drug companies have a major conflict of interest
• Physicians get most of their information from the drug companies
• Pharmacists don't get paid to provide this advice
• PBMs likely haven't earned back enough trust
• Health plans may not look at long-term benefits or risks
• Friends can give some scary advice
• Some foreign governments and state universities provide nice information
• Internet searches, but only if they know where to look and how to interpret the info