Muraglitazar and abatacept are likely to be the first Bristol-Myers Squibb products significantly affected by the company's recent moratorium on direct-to-consumer advertising during a drug's first 12 months on the market.

"For a minimum of 12 months following a launch of a new medication, Bristol-Myers Squibb will refrain from any direct-to-consumer branded mass media (television, radio and print) advertising to promote the medication," a DTC code released June 13 states.

The impact of the new policy on muraglitazar and abatacept, both of which are under review at FDA, will be especially pronounced since they might otherwise have been good candidates for DTC promotion.

Muraglitazar, which Bristol plans to market under the trade name Pargluva , is designed to treat a chronic condition (type 2 diabetes). Furthermore, Bristol will have to distinguish the dual peroxisome proliferator-activated receptor agonist from competing products like Lilly/Takeda's Actos and GlaxoSmithKline's Avandia .

Likewise, abatacept is designed to treat rheumatoid arthritis, another chronic condition with multiple heavily promoted treatments on the market, such as Amgen/Wyeth's Enbrel , Abbott's Humira and Johnson & Johnson's Remicade . Bristol likely will be looking to reach patients seeking an alternative to such TNF inhibitors.

However, the new company policy governing DTC communication means mass media advertising will not be part of Bristol's launch strategies for either Pargluva or abatacept.

For the first year a product is on the market, the company will engage in corporate advertising and disease awareness campaigns, but product-specific ads will be put on hold. Instead, the promotional policy for new products calls for targeting health care providers, with an aim to solicit feedback on the drug.

"During that period, we will focus our efforts on educating medical professionals about the new prescription medication and seek their input regarding their experience prescribing the medication," the code states.

Bristol's decision to impose a moratorium on DTC ads for new products follows calls for revised standards in broadcast promotional practices by several other pharma companies, including Pfizer, AstraZeneca and Johnson & Johnson.

The move is another sign that drug companies may be moving away from television advertising (¹ Also see "FDA Challenges Four Rx Ads; TAP Decides To Suspend Prevacid TV Campaign" - Pink Sheet, 25 April, 2005., p. 12).

Bristol's code includes a pledge to reference the Partnership for Prescription Assistance in promotional materials.

For all newly launched products, Bristol promises to "include information, where appropriate, in all print advertising, websites and patient brochures about patient assistance programs to help people get the medicines they need."

"In the United States, information about the Partnership for Prescription Assistance program will be included in our materials."

The partnership, a clearinghouse for Rx drug support programs, was created by the Pharmaceutical Research & Manufacturers of America in conjunction with other health-related groups and three states.

PhRMA CEO Billy Tauzin has recommended that all drug company ads include a reference to the industry initiative, but such a requirement is unlikely to appear in the association's forthcoming voluntary guidelines for DTC (see ² Also see "PhRMA Finalizing Voluntary Guidelines On DTC Advertising" - Pink Sheet, 20 June, 2005.).

Bristol said many of the other policies codified by its DTC document reflect longstanding practices. For instance, the company pledges to continue submitting all proposed mass media advertising to FDA "for advisory comments."

In addition, Bristol will "develop disease state awareness advertising, as appropriate, for diseases that may be potentially treated by our newly launched medications," the policy states.

The code also says that TV advertising will be targeted to the "appropriate" audience. "When we do advertise on television, it will be to appropriate audiences at appropriate times of the day," Bristol states.

"We will fully consider the benefits, risks and potential side effects of our medicines and the intended or unintended impact of communicating such messages to various audiences," the firm adds.

Bristol’s DTC Moratorium Will Affect Muraglitazar, Abatacept Launches

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