AMA Calls for Temporary Moratorium on
of New Prescription Drugs
June 14, 2005
The American Medical Association today announced new policy on direct-to-consumer (DTC) advertising of prescription drugs and implantable medical devices. The new policy includes imposing a temporary moratorium on the advertising of newly approved drugs and guidelines for pharmaceutical companies to follow when preparing DTC advertising.
"A temporary moratorium on DTC advertising of prescribed drugs and medical devices will benefit both the patient and physician," said AMA President-elect Ronald M. Davis, MD. "Physicians will have the opportunity to become better educated on the pros and cons of prescription drug uses before prescribing them, and will be better able to determine when they are best suited for their patients' medical needs."
In addition to the moratorium on newly approved drugs (the time interval for this moratorium will be determined by the FDA), the AMA adopted additional guidelines for DTC ads, they should:
- Provide objective information about drug benefits that reflect the true efficacy of the drug, as determined by clinical trials
- Show fair balance between the benefits and risks of the advertised drugs by providing comparable time or space and cognitive accessibility, and by presenting warnings, precautions and potential adverse reactions in a clear and understandable way without distraction of content
- Clearly indicate that the ad is for a prescription drug and refer patients to their physician for more information and appropriate treatment
- Be targeted for age-appropriate audiences; and should receive pre-approval from the FDA
The AMA also called for additional research into the effects of DTC advertising on the patient-physician relationship, overall health outcomes and health care costs.
"The AMA will work with the pharmaceutical industry for universal acceptance of the guidelines so that physicians can help patients obtain appropriate medications," said Dr. Davis.
This article was posted on June 20, 2006.