Culture Shock - Pharmaceutical Executive

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Culture Shock
The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety.


Pharmaceutical Executive


So where does this leave DTC advertising—the expected casualty of the Vioxx withdrawal? IOM and both Congressional bills have included at some point a moratorium on DTC during the initial two or three years of marketing. Some have argued for the idea of provisional approval, limiting certain marketing tactics (such as broadcast DTC) during the early phases of marketing. This is thought to create a slower adoption period, allowing more time to discover and mitigate new risks. But Congress is still making compromises. One bill maintains up to a three-year moratorium on DTC broadcast advertising, while the other bill recently deleted a provision that would have required DTC preapproval by FDA and fines if ads were found to be misbranded.

Free speech advocates may prevail, but a selective ban on DTC is already in place: Lilly's Forteo (teriparatide), Lilly and Amylin's Byetta (exenatide), and BMS drugs across the board have proposed avoiding DTC broadcast advertising, at least initially, as a risk-mitigation tactic. Even if FDA cannot ban broadcast DTC altogether, the agency can force greater disclosure of risk in a fair balance statement. This may make it extremely difficult to create an advertisement with a reasonable benefit/risk balance, unless the two-and-a-half-minute DTC commercial initiated by Celebrex (celecoxib) is a portent of things to come.

Nothing currently has the reach of broadcast advertising. But if staying power and slow uptake are the goal, we may see more personal sources of information to deliver drug information to consumers. Look for innovative ways to foster patient-based opinion leadership and word-of-mouth promotion and an increased use of interactive Web-based applications. Expect a much more complex and targeted set of interventions as personalized medicine and consumer segmentation continue to evolve. Direct but targeted messaging to consumers and patients in each of the stages of product usage and life cycle will be the new grail for consumer communication.

How will we pay for all these changes? User fees, most likely. Once considered a quid pro quo for FDA's timely consideration of an NDA, user fees will be applied to DTC review and, if the bills are signed into law, to drug safety. Companies will pay to keep their drugs on the market or to have them withdrawn.

The Culture of Drug Safety will continue to foster changes in our philosophy of drug use, the process to determine safety, and the procedures we use to mitigate risks. It will last throughout the life cycle of the drug. This culture will be stimulated often by early announcements of safety signals by FDA, journals, and drug companies. It will be amplified by the press and Congress.

This is the first of three articles on the Culture of Drug Safety. In the next two installments, we will explore further the implication of life cycle risk management and public-risk communications.

Louis A. Morris is president of Louis A. Morris & Associates. He provides consulting and research services to pharmaceutical and communications companies and has authored more than 100 articles and book chapters on health and risk communications. He can be reached at


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