AMA creates guidelines for advertising new drugs
AMA creates guidelines for advertising new drugs
Rules seek FDA review of all ads
It's an ambush of sorts — a patient, armed with information on the latest prescription drug gleaned from television or print advertising, insists that his or her doctor prescribe the drug, even if the physician is unfamiliar with the drug or unsure of its safety and efficacy.
The American Medical Association (AMA) would like physicians to have the opportunity to learn about new drugs on the market and be sure of their safety before patients start asking for them. Toward that end, the AMA has called for a moratorium on direct-to-consumer (DTC) advertising of new drugs and medical devices until the products have been shown to work and to be safe.
In a new policy, the AMA urged the FDA to require manufacturers to wait for an unspecified period after a drug or device obtains regulatory approval before launching direct-to-consumer advertising.
Advertising a two-edge sword
According to the AMA's president-elect, Ronald M. Davis, MD, the AMA is not opposed to pharmaceutical companies advertising to consumers in all cases.
"There are some potential benefits to DTC advertising," Davis says. "The ads can educate patients about the availability of these drugs, can increase awareness about the drugs, and may also prompt communications about the medications between patients and physicians."
In general, Davis says, anything that promotes communication between doctor and patient is a good thing.
"On the other hand, the ads may not provide a full and balanced presentation of information on the benefits and risks among patients about whether this drug is appropriate for the patient and whether it will accomplish what the patient is hoping for," he adds.
Besides asking that the FDA set moratorium periods for new prescription drug or device advertising, the AMA adopted additional guidelines for DTC ads:
- Ads 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;
- An ad should clearly indicate that it is for a prescription drug and refer patients to their physician for more information and appropriate treatment;
- Ads should be targeted for age-appropriate audiences;
- Advertising should receive pre-approval from the FDA.
The AMA also calls for additional research into the effects of DTC advertising on the patient-physician relationship, overall health outcomes, and health care costs.
Davis says the most significant request is that all DTC advertising be submitted to the FDA for preapproval before being aired or printed. This is similar to one of the "guiding principles" issued in 2005 by the Pharmaceutical Research and Manufacturers of America (PhRMA), which recommends — but does not require — that pharma companies: submit all new DTC television advertisements to the FDA before releasing them for broadcast; ensure ads provide balanced presentation of risks and benefits; and educate health professionals about new medicines or therapies before launching DTC advertising.
"These [guiding principles] go beyond existing regulatory requirements in many ways and help promote patient and physician discussions," according to PhRMA President and CEO Billy Tauzin. Twenty-six PhRMA member companies have adopted the guiding principles, which took effect in January 2006.
Davis says the AMA will work cooperatively with the pharmaceutical industry toward gaining universal acceptance of the DTC guidelines.
Resources
For more information:
- American Medical Association, Board of Trustees Report 9: Direct-to-consumer advertising of prescription drugs, House of Delegates 2006 Annual Meeting. Available at www.ama-assn.org.
- Pharmaceutical Research and Manufacturers of America, Guiding principles on direct-to-consumer advertising, July 2005. Available at: www.phrma.org/files/2005-11-29.1194.pdf.
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