OP ED: Pharma should prepare for more criticism, scrutiny

About the last thing the pharmaceutical industry needed was for the Food & Drug Administration (FDA), the agency providing an essential imprimatur on pharma brands critical in gaining public trust, to have its credibility called to the carpet by a series of events that fundamentally changed the environment for the worse - not only for the agency, but also for the drug industry itself.

About the last thing the pharmaceutical industry needed was for the Food & Drug Administration (FDA), the agency providing an essential imprimatur on pharma brands critical in gaining public trust, to have its credibility called to the carpet by a series of events that fundamentally changed the environment for the worse - not only for the agency, but also for the drug industry itself.

Additional black-box warnings on labels, high-profile drug withdrawals due to safety concerns, a perceived lack of regulatory oversight regarding flu- vaccine manufacturing, Senate testimony by a high-ranking FDA employee about lack of vigilance, and a year-end Journal of the American Medical Association editorial calling for change in the FDA are only a few events that signify a growing tide of scrutiny and criticism aimed at the FDA and, subsequently, the pharma industry.

The FDA will have to work very hard in 2005 to look better in the eyes of the public and of policy makers. For that to happen, it stands to reason that the FDA will employ stricter actions that, in turn, will make the pharmaceutical industry look a little worse. This comes at a time when the public image of the industry has suffered greatly. A mid-2004 Harris poll documented a steep drop in approval ratings that left the industry in the company of Big Tobacco and oil. Turning that around is a big job for the industry as a whole. Not making it worse is going to be the work of individual companies.

During 2005, there will be several milestones to remind the public of FDA credibility and perceived industry shortcomings. For example, there will be a report on drug safety conducted by the Institute of Medicine as requested by the FDA. Such a report will provide a pathway for the FDA to rehabilitate its image, but will do so by providing high-profile focus on the perceived safety shortcomings of the industry. Other immediately foreseeable media milestones include:

  • A February FDA Advisory Committee meeting to examine the safety of both Celebrex and Bextra - hot topics in the wake of the Vioxx withdrawal by Merck.

  • The appointment of key FDA division heads, including a new FDA commissioner.

  • The return of a permanent director of the FDA's Center for Drug Evaluation and Research.

  • The outcome of investigations by two federal agencies into the Vioxx withdrawal.

  • Congressional hearings related to ongoing concerns.

  • Advisory committee meetings considering new drug approvals.

    Though these are industry issues, it is incumbent on public affairs pros working for and with individual pharmaceutical companies to anticipate and strategically plan for these milestones and reinforce safety messaging.

    Given the attention to long-term safety data in the post-Vioxx era, a place to start is by examining and characterizing each company's track record on the issue of post-marketing commitments. Inevitably, in the coming months industry critics are going to examine the progress of the industry as a whole. Companies must prepare to defend their progress, or lack thereof, regarding these commitments. Gaps that exist between what individual companies have said they would do and what they have actually done are best managed before the issue erupts into crisis.

    Adverse event reporting will be another focus as companies are asked to define their methodologies under the current system. Companies might find that their individual response times and scope of reporting will be publicly compared. By conducting internal audits now, companies can prepare by developing messaging for such scrutiny sooner rather than later.

    Advisory committee meetings are not only one of the highest-profile venues for individual companies, but are also where the branding of a new pharmaceutical product draws its first public breath. Post-2004 issues related to safety (particularly long-term safety) are going to be crucial. But there is a balance that must be drawn between communicating a good safety plan and not alarming patients and doctors about safety issues. Communications in relation to advisory committees, always a tricky thing, have now become even more complicated.

    Lastly, in the face of mounting criticism over the way the FDA has regulated industry marketing activities, expect a greater number of warning letters to be issued. Communications professionals have to heighten their own scrutiny of marketing practices to ensure that pre-approval awareness efforts and post-approval marketing do not invite unwanted warning letters to individual companies.

    This environment will affect everyone, and the individual players in the pharmaceutical industry are fair game for scrutiny and criticism, even for those companies with the best reputations. Understanding and preparing for the coming environment is key to future success.

  • Mark Senak is an SVP at Fleishman-Hillard who advises pharma clients on public affairs issues, with a focus on drug-marketing issues related to regulatory matters and crisis.

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