When a drug firm embarks on Phase I and II clinical trials, ready or not, public relations professionals and their clients march into a field of communications challenges.
Marketers quickly realize that managing perceptions about their drug and corporate image with advocacy groups become as crucial as getting the new drug application filed.
Excluding patient groups from drug development and marketing issues is no longer an option. Today, it is imperative for marketers to mobilize advocacy groups to advance their
causes.
Advocacy groups advance clinical findings by providing direct feedback on the feasibility of accruing clinical trial participants, assessing the relevance and value of disease
management programs and helping to alert patient members to clinical trial enrollment opportunities.
They accelerate drug approval by discussing the compound's value among themselves and their colleagues, who may include regulatory experts and media; voicing concerns at the
"open mike" during FDA advisory hearings; and creating and participating in expanded access programs.
They secure drug coverage by lobbying for reimbursement of approved drugs, assuring that suggested indigent care programs are effective and serving as spokespeople to
regulators and the media.
They promote healthy behaviors by disseminating up-to-the-minute information on new drugs relevant to their members through their groups publications, bulletins and Internet
homepages; designing health promotion programs for the community at large and drawing doctors' attention to your drugs.
Just like the medical community, advocates want accurate and balanced information on epidemiology, study design and research programs so they can make their own assessment of
investigational drugs.
Drug companies can quench that information thirst by connecting advocates to investigators who can speak from personal experience about a study's progress. If one wants to
communicate drug information during the pre-approval stages, the simplest rule to follow is the FDA's very own: Use fair balance, offer full disclosure and show independence.
Senior management - from CEOs to marketing VPs and brand managers - can effectively incorporate advocacy into marketing and promotion by asking a few simple questions:
- Have you considered inviting advocates to sit on one of your marketing or scientific advisory boards? If so, are you satisfied with the role they play?
- Have advocates been exposed to your product's clinical data?
- Do you know if advocates support your protocols? Data? Clinical design? Product? Are they criticizing them to their members, other advocates, media, or the
FDA? - Are you working with advocacy groups to accrue patients or to develop investigator/patient support materials?
- Is there legislation that could affect the success of your brand, which could be attacked by advocates?
- Are their labeling changes you would like advocates to know about?
- Are there regulatory stumbling blocks inhibiting your brands that could be helped by advocate support?
- Have you made efforts to work with advocates to ensure product reimbursement?
When you look back to 1985, consumer activism around specific diseases was an unfamiliar and relatively obscure occurrence.
Today the pace of consumer involvement has increased dramatically. Activism has moved beyond the AIDS arena to cancer, women's health, and various CNS disorders, migraine and
even heartburn.
Many more coalitions are being formed, where diverse professional and consumer groups band together under a united mission.
Working with advocacy groups takes understanding of their individual agendas, and asking yourself the right questions throughout a brand's market lifestyle. No longer an
option, working with consumer activists can actually aid in the marketing and medical process.