Direct Advertising by Pharmas Under Scrutiny
The American Medical Association has called on the federal government for more oversight of direct-to-consumer advertisements (DTCA), as noted in a release issued by the national organization.
The AMA notes particular concerns related to prescription drugs. These were shared by AMA President-elect, Nancy Nielsen, MD during her recent testimony before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations.
The AMA is concerned that advertisements for pharmaceuticals often portray only the positive effects of drug therapies, not considering or describing risks or the importance of ongoing communication between patients and their clinicians. Dr. Nielsen detailed guidelines that should be used to assess DTCA to ensure the accuracy of information portrayed in ads.
Last year, warnings issued by the FDA about DTCA violations took about six months to process as reported by the GAO. In one extreme example, the warning letter was not issued for three years. Interestingly, the number of letters issued by the Agency has dramatically declined.
The GAO completed a report in 2006 which noted that by the time letters were received by pharmaceutical companies, unapproved advertising had often been removed. Moreover, these letters were not always an effective approach, as advertising would continue after warnings.
The delays commenced in 2002. At that time, the FDA commenced a new policy that required all warning letters be reviewed by legal counsel before sending them out. Prior to this requirement, letters were usually issued within a one month period.
May 21, 2008 Related topics: Legal & legislative, Trends, Quality, Safety, Errors