December 10th, 2008

Drugmakers to Note Actors, Make Other Ad Changes

By Susan Heavey

The drug industry is taking more voluntary steps to make its consumer marketing more straightforward, including making it clear when actors are used in commercials and other advertisements, the leading industry lobby group said on Wednesday.

The Pharmaceutical Research and Manufacturers of America (PhRMA), under fire from some lawmakers and consumer groups for aggressive marketing practices, also said advertisements that are unsuitable for children should run only during television programs or in publications that target adults.

Ads for impotency drugs such as Pfizer Inc’s Viagra have drawn the ire of lawmakers and others for suggestive content, and Pfizer’s ads for its top-selling cholesterol drug, Lipitor, featuring artificial heart inventor Dr. Robert Jarvik, have been criticized for using an actor in some scenes.

PhRMA’s latest action updates its 2005 pledge to rein in advertising in the wake of Merck & Co Inc’s Vioxx recall.

Drugmakers have said advertising is critical to educate consumers and doctors about available treatments. The United States and New Zealand are the only countries that allow drugmakers to target consumers, although some European regulators have weighed whether to lift such bans.

The FDA regulates industry ads, but it has said it lacks resources to review every piece of company marketing.

Critics of PhRMA’s guidelines point out they are voluntary and not enforceable by the U.S. Food and Drug Administration (FDA). They also are not necessarily adopted by all drugmakers and exclude other types of medical companies, such as those making devices or over-the-counter drugs.

Several advocacy groups said the guidelines were an attempt to prevent further regulation.

“What is needed is meaningful FDA regulation” such as a ban on celebrity endorsements and allowing the FDA to warn companies without prior review by the agency’s lawyer, said Peter Lurie of Public Citizen’s Health Research Group.

Democratic lawmakers have held hearings to highlight practices in pharmaceutical ads they find objectionable, such as graphics and other distractions that divert attention from a drug’s risks.

“On one hand, PhRMA has taken our Committee’s concerns seriously ... on the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection,” said Rep. Bart Stupak, a Michigan Democrat, who heads the U.S. House of Representatives Energy and Commerce Committee’s investigative panel.

Massachusetts Democrat Edward Kennedy, who chairs the Senate’s health committee, blasted the guidelines and called for stronger regulation with a new FDA commissioner under the Obama administration. “Voluntary industry guidelines on direct-to-consumers drug advertising are no substitute for effective enforcement of strong regulatory requirements. Patients deserve no less,” he said.

Earlier this week, Rep. Henry Waxman, a California Democrat who will take over the Energy and Commerce Committee in January, said he would support efforts to give the FDA power to ban consumer advertisements for the first few years a drug is sold in the United States.

PhRMA said its new guidelines incorporate feedback from lawmakers and physicians. They are due to take effect March 2, 2009.

“Our Guiding Principles help ensure that DTC advertising appropriately and accurately conveys important information about medical conditions, medicines and other treatment options,” said PhRMA president and chief executive Billy Tauzin, a former Republican member of Congress from Louisiana.

Pfizer and AstraZeneca said they support the revised guidelines. PhRMA said it would announce on its website which companies adopt them.


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