December 11, 2008

Stricter Guidelines For Drug Marketing

A leading drug industry lobby group claims its taking steps to make consumer marketing more straightforward, a process that includes making it clear when actors are involved with commercials.

After recent scrutiny from lawmakers and consumer groups for aggressive marketing tactics, the Pharmaceutical Research and Manufacturers of America (PhRMA) made the announcement.

Opponents of prior drug industry practices want advertisements that are unsuitable for children to only run only during television programs or in publications that target adults.

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

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.

PhRMA's latest action updates its 2005 pledge to rein in advertising in the wake of Merck & Co Inc's Vioxx recall, but drug makers maintain advertising is critical to educate consumers and doctors about available treatments.

The United States and New Zealand are the only countries that allow drug makers to target consumers, although some European regulators have considered lifting such bans.

The FDA said it lacks proper resources to review every piece of company marketing.

Critics of PhRMA's guidelines say they are not enforceable by the U.S. Food and Drug Administration. 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 focused on practices in pharmaceutical ads they find objectionable.

"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.

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.

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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