The largest U.S. physicians' group on Wednesday called for moratoriums on consumer advertising promoting new drugs and medical devices until the products are shown to be safe and that they work.
In a new policy, the American Medical Association urged the U.S. Food and Drug Administration to require manufacturers to wait for an unspecified period after a drug or device obtains regulatory approval before launching direct-to-consumer advertising in print, on television, or elsewhere.
The doctors' group had considered a years-long moratorium, but decided to let the FDA set the time span, which could depend on whether the drug or device breaks new ground.
Physicians have complained about patients who demand inappropriate drugs after being persuaded by a drug company's advertisement. Drug makers have said the ads educate the public and only advise patients to ask their doctors.
The AMA's house of delegates, setting the group's policy at its annual meeting, recommended the FDA pre-approve such advertisements and ensure they are based on objective information from clinical trials, reveal the balance between a product's benefits and risks, and define warnings and potential adverse reactions clearly and understandably.
"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," the AMA's president-elect, Dr. Ronald Davis, said in a statement.
A drug industry group said it shares the AMA's goal of educating the public, citing last year's agreement among manufacturers to voluntarily inform the health-care community before launching consumer ads.
"The length of time this requires will vary from medicine to medicine, and companies will likely meet this goal in different ways," said Dr. Paul Antony of the Pharmaceutical Research and Manufacturers of America.
The AMA's action was prompted by recalls of high-profile drugs such as Merck's 2004 withdrawal of Vioxx, which had a huge advertising budget, and problematic side affects that have 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 plaintiffs have argued in lawsuits that Merck continued to promote the painkiller despite knowledge that it carried risks.
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