Many health policy observers are concerned about the impact of drug company promotion of "off-label uses" - unapproved or new uses of drugs that were approved for another primary use.
The FDA is now drafting guidelines on promotion of off-label uses, but the draft concerns Senator Henry Waxman, as Ed Silverman explains on his Pharmalot blog. Excerpt:
Waxman is concerned the agency is opening what he calls an “ill-advised guidance” and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.”Posted by schwitz at December 1, 2007 08:08 AM | TrackBack
The media has focused on toy safety as it should, but seems to be ignoring the huge danger from the lack of proper labeling of medicine. Look in your medicine cabinet and tell me the country of origin for your prescription & non-prescription drugs. That's right no requirements for the country of origin on medicine or where the ingredients came from. This is a perfect opportunity to assist the counterfeiters in marketing their crap with one less thing for them to worry about. Your toys, shirts, & underwear must be labeled but not your pills. Are those fish oil pills from fish in a polluted pond in China.... who knows? Perhaps it because of the conflict of interest of the drug manufactures that don't want you to know. Another example of the Government/FDA not doing its job ......... Why is it not a requirement that ALL retail products including your drugs be labeled with the country of origin.
Posted by: Not Soandso at December 2, 2007 11:21 AM