Senate Majority Leader Bill Frist (R-Tenn.) is asking the Government Accountability Office to examine FDA's oversight of direct-to-consumer advertisements and their impact on drug costs and usage.

Frist is requesting that GAO "analyze FDA's oversight of prescription drug advertising, the pharmaceutical industry's spending on such advertising, and the potential impact on utilization, health care spending, patient education and awareness," the majority leader said in a July 1 press release.

GAO is being asked to analyze FDA's oversight of DTC, what types of resources should be dedicated to advertising review activities, and how best to give doctors and patients increased access to clinical data and post-marketing surveillance activities.

The senator announced the GAO request in connection with his call for the pharmaceutical industry to voluntarily restrict DTC advertising during the first two years that a new drug is on the market.

Frist made his remarks about the DTC moratorium and the GAO report on the Senate floor.

Used appropriately, DTC ads "can empower patients without inflating need or distorting medical realities," Frist said in the release.

"But research evidence indicates that this blitz in direct marketing has unwittingly led to inappropriate prescribing, which most importantly can compromise patient safety and care."

"That's why I'm calling for pharmaceutical companies to implement a voluntary two-year restriction on DTC advertising efforts for newly released drugs," he said.

Bristol-Myers Squibb announced in mid-June that it would not promote new drugs through DTC ads during the first 12 months of marketing (¹ Also see "Bristol Promises 12-Month Moratorium On DTC For Newly Launched Products" - Pink Sheet, 14 June, 2005.).

The Pharmaceutical Research & Manufacturers of America is developing voluntary guidelines for DTC advertising that are expected to be presented to the organization's board in July.

The PhRMA guidelines are not expected to include a moratorium on advertising for new products. However, they could include a recommendation that ads run at appropriate times to reach the targeted audience for whom the drug is approved (² Also see "Late Night Viagra: Pfizer Supports Limiting Hours For Erectile Dysfunction DTC Ads" - Pink Sheet, 23 June, 2005.).

- Meg LaPorte

Sen. Frist's Diagnosis On DTC: GAO Report, Two-Year Moratorium For New Drugs

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