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DTC advertising reforms urged

Bill Frist, majority leader of the US Senate, has called on all pharmaceutical companies to voluntarily restrict direct-to-consumer advertising during the first two years that a drug is on the market

Bill Frist, majority leader of the US Senate, has called on all pharmaceutical companies to voluntarily restrict direct-to-consumer (DTC) advertising during the first two years that a drug is on the market.

Frist, who raised the DTC issue in remarks to the Senate on July 1, also called for other major changes, including giving the Food and Drug Administration (FDA) prior review and approval authority for all DTC ads.

He said he had asked the Government Accountability Office to investigate the FDA's oversight of DTC ads, the pharmaceutical industry's spending on the ads, and the advertising's effect on healthcare costs, patient education levels and other factors.

“It's time for drug companies to clean up their act - if they don't, Congress will,” Frist said during his remarks. The influential Tennessee Republican, who is also a physician, argued that DTC ads go “over the heads of doctors” to sell drugs to patients and “fuel America's skyrocketing prescription drug costs” by creating an artificial demand for medicines.

He also claimed that many DTC ads mislead patients, either by overstating a product's benefits or minimising the risks.

Frist blamed the problem in part on the Clinton administration, which he said “opened the door too widely” to DTC advertising. “As a result, direct-to-consumer advertising exploded to levels that many could not have anticipated, and this has driven up prescription drug use and spending and, I believe, led to inappropriate physician prescribing,” he stated.

Representative body, the Pharmaceutical Research and Manufacturers of America (PhRMA) responded with a statement emphasising the educational value of DTC advertising and the industry's current efforts to develop voluntary principles to help ensure the ads are used appropriately.

“Evidence does not link advertising and drug prices,” PhRMA senior vice president Ken Johnson stressed in the statement. He also noted that research shows that drug spending trends are actually slowing.

However, some groups, including the AIDS Healthcare Foundation, expressed support for Frist's proposals. “We urge Congress and the FDA to take a cue from Senator Frist and regulate this multi-billion dollar pharmaceutical industry that far too often places its revenue above its responsibility to consumer health and safety,” the AHF said.

Kate Fodor reporting from the US.

2nd September 2008

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