Jun 18 2006
The American Medical Association (AMA), the largest doctors group in the U.S., has announced a new policy on the direct-to-consumer advertising of prescription drugs and implantable medical devices.
The group is also calling for a temporary moratorium on the advertising of newly approved drugs and guidelines for pharmaceutical companies to follow when preparing advertising to the public.
AMA President-elect, Dr. Ronald M. Davis says a temporary moratorium on the advertising of prescribed drugs and medical devices will benefit both the patient and physician and give doctors the opportunity to become better educated on the pros and cons of prescription drugs before prescribing them.
They will then, he says, be better equipped to determine which drugs are best suited to their patients' medical needs.
Doctors have complained about patients who demand inappropriate drugs after being persuaded by a drug company's advertisement.
Drug manufacturers say the advertisements aim to educate the public and advise patients to consult with their doctors.
In addition to the moratorium on newly approved drugs, which will be determined by the Food and Drug Administration (FDA), the AMA has adopted additional guidelines for direct-to-consumer advertising:
- they should provide objective information about drug benefits that reflect the true efficacy of the drug, as determined by clinical trials.
- they should 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.
- they should clearly indicate that the advertisement is for a prescription drug and refer patients to their physician for more information and appropriate treatment.
- and they should be targeted for age-appropriate audiences and they should receive pre-approval from the FDA.
The AMA also wants more research done into the effects of direct-to-consumer advertising on the patient-physician relationship, overall health outcomes and health care costs.
This action on the part of the AMA was prompted by recalls of high-profile drugs such as Vioxx, which had a huge advertising budget, and illustrates that problematic side affects can become apparent sometimes years after a drug or device hits the market.
Vioxx was found to increase the risks of heart attack and stroke, and some patients have argued in lawsuits that the drug company Merck continued to promote the painkiller despite knowledge that it carried risks.
The AMA says it will work with the pharmaceutical industry to achieve universal acceptance of the guidelines to enable doctors to help patients obtain appropriate medications.