FDA Reviews Rules Governing Drug Ads For Consumers
The Food and Drug Administration (FDA) is considering whether to modify its policy on direct-to-consumer (DTC) advertising, which was relaxed in 1997, prompting an advertising explosion. Many physicians maintain that the ads need to be improved.
The 1997 policy change led to a marketing explosion, with pharmaceutical ads promoting prescription products on television and radio, in print, and on the Internet estimated to cost at least $4 billion annually.
During public hearings on the issue in November in Washington, D.C., physicians and public-health advocates told regulators that the ads can be informative at their best and create unwarranted demands for drugs at their worst.
Joseph Cranston, Ph.D., director of Science, Research, and Technology at the AMA, testified that DTC advertising has been a topic of debate among his organization's membership, which is considering recommending a ban on such ads.
However, it remains unclear whether the FDA has the authority to impose such an advertising moratorium, according to Robert Temple, M.D., director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research.
Some legislators already support a moratorium. Prominent among them is Senate Majority Leader Bill Frist (R-Tenn.), who said he would back a two-year moratorium. The Pharmaceutical Research and Manufacturers of America (PhRMA) said that beginning in 2006 its members will voluntarily delay broadcast ads of new products for six months after introduction. The policy does not apply to print ads.
Current FDA regulations require ads to be submitted for review at some time during an ad campaign. In 2004, 586 TV ads and 52,848 other types of promotions were submitted to the agency. Consumer advocates urged the FDA to change its policy to require agency clearance of an ad before it is broadcast or printed.
Revisions in FDA policy are unlikely to come until next spring, while the agency continues to accept comments on the issue through the end of February 2006, according to regulators.
The range of issues at the November public hearing included industry groups' claims that the DTC advertising of prescription drugs can lead to better health care and consumer groups' suggestions that they can mislead the public.
Drug makers defended the ads, saying that they motivate people to seek a doctor's help. J. Patrick Kelly, president of Pfizer U.S. Pharmaceuticals, said that 65 million people have talked to a doctor as a result of the ads and that 29 million had discussed a condition for the first time, according to a study by Prevention magazine.
DTC ads have been under scrutiny since the fall 2004 recall of Vioxx, due to risk of cardiac complications. The drug was heavily promoted to consumers, with the manufacturer, Merck & Co., spending up to $160 million annually on such Vioxx ads.
DTC ads are acceptable, Cranston said, when they enhance patient education about medical conditions, balance their presentation of the drug's risk with its benefits, facilitate physician/patient communication, and are withheld from release until physicians have been educated about a new drug.
But several studies have raised serious questions about the negative aspects of DTC ads, such as lack of information on the condition the drug aims to treat, using emotional appeals, and presenting inflated benefits of the drug.
“These studies raise the question of whether commercially driven direct-to-consumer ads are as informative as they need to be,” Cranston said.
Cranston said research has found that the ads tend to improve communication between physicians and patients, but a subset of patients will insist a physician prescribe a specific drug due to advertising they saw.
When asked by an FDA official how to improve the balance between the presentation of risks and benefits in television ads, Cranston said regulators should seek consultants to suggest guidelines to encourage a balance.
The AMA is preparing a report on the ads and will consider recommendations, including two calling for ad bans, in June 2006.
Temple said the FDA is not considering changes to the advertising requirements for direct-to-physician advertising, which is estimated to exceed $5 billion annually.
PhRMA advertising principles are posted at<www.phrma.org/publications/policy/admin/2005-08-02.1194.pdf>.▪
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Published online: 2 December 2005
Published in print: December 2, 2005
Notes
The $4 billion spent annually to market prescription drugs to the public is under regulatory scrutiny for the first time in nearly a decade.
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