Standards for comparative drug claims in direct-to-consumer ads will be one topic for discussion during a Sept. 22-23 FDA public meeting on consumer-directed promotion of prescription drugs.

"What kind of additional information, if any, should be required in the presentation of comparative drug claims to help consumers understand and critically evaluate them?" FDA asks in an Aug. 11 Federal Register notice announcing the meeting.

The notice also asks "what kind of additional information, if any, should be required in the presentation of comparative cost claims?"

"Should this information vary if prescription drugs are compared to other prescription drugs, over-the-counter drugs, or other types of treatments?"

The meeting is being called to solicit feedback on the current regulatory approach to DTC prescription drug promotion. Stakeholders are being asked to present research to address various questions surrounding DTC advertising.

Comparative claims in DTC ads have surfaced in the prescription allergy drug market after the OTC switch of Schering-Plough's Claritin .

Aventis and GlaxoSmithKline have run DTC ads comparing the safety or cost of their products to over-the-counter competitors. Aventis' Allegra ads highlight the allergy drug's non-sedating profile in comparison to both prescription and OTC competitors (¹ Also see "Allegra DTC Ads Include Comparative Claims Against Zyrtec, OTCs" - Pink Sheet, 4 August, 2003., p. 17).

GSK had earlier compared the copay of the nasal steroid Flonase to the cost of oral antihistamines. FDA objected to the ads on the grounds that Flonase is approved for a narrower range of indications, and so it is misleading to imply that cost is the only consideration (² Also see "Flonase, Zaditor DTC Ads Cited By FDA; Both Allergy Campaigns Are Over" - Pink Sheet, 30 June, 2003., p. 42).

The FDA notice also asks whether DTC promotion oversimplifies the safety and effectiveness of prescription drugs. "If so, what effect does such oversimplification have on public health? Specifically, what effect does it have on consumer understanding of and use of prescription drugs?"

FDA poses questions about the effect of DTC promotion on patient-physician interactions and whether DTC ads affect physician prescribing decisions. The notice also queries whether consumers can accurately assess claims made in ads.

Alternative types of risk disclosure other than the brief summary will also be discussed at the meeting. "Are there alternate types of risk disclosures that would be more effective or informative?" FDA asks.

The meeting will also address how new technologies and methods of promotion, such as the Internet and infomercials, change the communication of risks and benefits of products.

FDA loosened its restrictions on broadcast ads in 1997 and issued a guidance two years later. At the time, the agency announced that it "intended to evaluate the effects of the guidance and DTC promotion, in general, on the public health."

The upcoming meeting will allow the agency to "consider its own research and the research of others to explore whether, and, if so, how, the agency's current regulatory approach should be modified, including whether the guidance should be withdrawn, continued, or modified to reflect the agency's current thinking."

"The public meeting being announced in this document is one component of the approach the agency is taking to fulfill its commitment to this evaluation."

DTC advertising and regulation has received considerable attention since FDA issued its 1999 guidance. The most recent example of criticism of DTC advertising regulation comes from House Committee on Government Reform ranking Democrat Henry Waxman (Calif.).

A report prepared for Waxman, entitled "Investigating the Bush Administration's Promotion of Ideology Over Science," contends that FDA has distorted the results of DTC research to support the position of the pharmaceutical industry (³ Also see "FDA DTC Stance Is “Ideological,” Not Science-Based, Rep. Waxman Says" - Pink Sheet, 7 April, 2003. p. 13). The Waxman report maintains that a Jan. 13, 2003 FDA Talk Paper "turned a balanced study into an endorsement of direct-to-consumer advertisements," by reporting only a few negative results and countering them with "an upbeat message."

DTC Comparative Drug Campaigns To Be Addressed At FDA Public Meeting

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