Pharma Reform

The residual effects of pharmaceutical industry indiscretions of the past will linger for some time but also make it all the more important for the industry to be more truthful and forthcoming in their marketing and corporate communications.  The recent disclosures and concerns about GSK’s handling of the potential for cardiovascular events associated with the use of Avandia^® just further highlights the challenges facing the industry in reestablishing trust.

So what to do from a marketing perspective?  I fully appreciate the need to grow sales and deliver results but if the only way you feel you can do this is by not being truthful, not being fully truthful,  or not being forthcoming about risks, you can not expect to reestablish trust in the market. Trust requires truth and integrity and consistent behavior over time.

One way to get after this is to assess what you are doing and begin to make any necessary adjustments in your marketing planning to reflect truthful disclosures and integrity in marketing. You can’t expect people to trust you or what you say about your product if you can’t be truthful and honest with yourself in doing your own product assessment.

1)      Product Assessment (based on FDA approved label claims only)

• What indications are approved for your product?

• What limitations on use does your product have?

• What patient population is most likely to benefit from your product? Do you know which patients will not respond well or as you might expect?

• How would you describe this population within the confines of your approved label claims?

• Does your product have two well controlled peer-reviewed published clinical data to support the patient populations you plan to market to? (this means the trial data used for the approved claims are available to clinicians for their own evaluations and interpretations)

2)      Market assessment (given your product profile and label claims as assessed above)

• What market is available to you? How large or small is it?

• What limitations are there on your market potential? (e.g., age constraints, drug interactions, etc.)

• How much of the market is not available to you due to potential for side effects or adverse reactions?

• How much of your current revenue is beyond the approved label claims? Are you actively or passively trying to increase sales beyond your approved label claims?

3)      Competitive assessment

• What other products have similar label claims?

• Is your product the best product on the market to treat the approved indications?  Why?  Why not?

• Is your product risk profile (side effects and adverse reactions) better or worse than competitive products?

• Do you have label claims or two well controlled peer review published trials to favorably differentiate your product from competitive products?

• Do your competitors have label claims or two well controlled peer review published trials to favorably differentiate their product from your product?
• If your product is the market leader, how did it get there?
  1. First to market?
  2. Definitive favorable product differentiation based on label claims
  3. Marketing presence (e.g., share of voice, spend, or execution)?
  4. Market expansion beyond approved claims
  5. Implied favorable product differentiation from competitors

4)      Marketing communications assessment

• Is your messaging consistent with the patients identified in the product assessment above?

• Are the claims you want to make, or are making, consistent with your label claims or two well controlled peer-reviewed published trial data?

• Does your advertising imply or suggest a broader market than label claims might include?  Is this intentional?

• Are adverse reaction and side effects an important part of your communications plan or are they merely a regulatory necessity?

• Is your communications strategy inclusive of building trust in your advertising and promotion?

5)      Tactical plan assessment

• Are programs consistent with label claims and the indicated patient populations

• Are your tactics designed to capture patients beyond the label claims of the product?

• Are your tactics designed to encourage market expansion through off-label use driven by “physician choice”

• Are there veiled inducements (e.g., speaker fees, sponsorships, consulting fees, or promises of clinical trial participation) to encourage healthcare providers to espouse implied product differentiations or implied uses beyond label claims?

• Are your medical education programs designed to capture patients identified in the product assessment above and to encourage appropriate product use or are they intended to expand use beyond that population.

• Do you find yourself rationalizing why something is ok and consistent with labeling?  Are your activities defensible without rationalizing?

• Do you have organizational controls to make certain execution of the tactical plan is consistent with the intended plan and can not stray  (e.g., no maverick sales promotions, no locally funded inducements)

As you go through assessing your own products you should have additional questions that make you stop and think about the intent of what you are doing verses what you say you are actually doing.  To reestablish trust in marketing, communications and actions must be truthful, must not be misleading, must be compliant (regulatory and legal), and must consistently support the best interest of patients over time.  No amount of revenue or profit opportunity can or should be able to change this.  Remember, trust and integrity are not a matter of convenience or circumstance.

Next we will discuss pricing practices and their impact on reestablishing trust.

mike@pharmareform.com