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Pharmaceutical trade group issues draft guidelines on consumer advertising
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WASHINGTON — A list of “guiding principles” for direct-to-consumer advertising of prescription drugs was released in draft form by a drug industry trade group.
The board of directors of the Pharmaceutical Research and Manufacturers of America (PhRMA) approved the “substance” of the guidelines, which will now be further refined by the group’s member companies, according to a press release from PhRMA.
The 15-point voluntary guidelines, if approved and adopted by PhRMA member companies, will ask drug makers to take time to educate health professionals on new drugs and to ensure that consumer ads outline risks as well as benefits.
The guidelines also recommend that ads be submitted to the Food and Drug Administration for approval and that risks and benefits be clearly identified.
Portions of the guidelines go beyond current FDA regulations, stating that all television ads “should be targeted for audience and age appropriateness” and that “companies are encouraged to include information about assistance programs for the uninsured and low-income,” according to the PhRMA press release.
To improve consumer education, the guidelines state that direct-to-consumer [DTC] advertising “should be accurate and not misleading; make claims only when supported by substantial evidence; reflect balance between risks and benefits and be consistent with FDA-approved labeling.”
Some critics of the pharmaceutical industry, including Republican Senate Majority Leader Bill Frist, have suggested a 2-year moratorium on consumer advertising for newly approved drugs. Sen. Frist said at a press conference that he was disappointed PhRMA’s guidelines did not include his request for a moratorium.
The Wall Street Journal reported that the FDA is expected to announce a major review of DTC ads, which could result in tougher regulations. Sen. Frist pledged that he would continue to monitor the issue.
“I will continue to evaluate whether legislative remedies are necessary to put patient safety first and help control prescription drug costs,” he said.
Critics of the pharmaceutical companies argue that DTC ads promote the use of newer, more expensive drugs, ignoring older and equally effective drugs, thus increasing health care spending.
PhRMA counters that DTC ads play a role in educating patients and encouraging them to discuss illnesses with their physicians. PhRMA also claims DTC ads can play a role in helping consumers comply with physician-prescribed treatments.