Consumer Backlash and Regaining Consumer Trust
The Wall Street Journal has been filled with articles describing the consumer realization that they are not being given the information they need to know about their prescription medications in language they can understand.
The jurors in the Merck trial complained after their vote that "labels and communications from drug companies were incomprehensible." (Wall Street Journal, August 22, 2005 ) One juror demanded:
"Give us in layman's terms what the drug can do to us. Let us decide."
Other jurors complained that they could not understand the scientific evidence being presented and that it sailed right over their heads:
"We didn't know what the heck
they were talking about." Merck's general counsel responded:
"We are learning as we go along about how best to present evidence to juries composed of lay people."
The Merck Vioxx case illustrates the importance of communicating the right balance of risks and benefits in clear language that consumers can understand. Consumers are not going to put their lives at risk by sitting back and following medication instructions they do not understand.
Consumers Want to Know the Risk in Language They Can Understand
 If you were a consumer would you be able to understand these terms that commonly appear in materials distributed by pharmaceutical companies to patients?
- Myocardial Infarction?
- Thrombocytopenia?
- Teratogenicity?
- Low Absolute Risk?
- Acute Renal Failure?
- Onset of Proptosis?
The answer is NO. The average consumer won't understand complicated medical terminology.
Even worse, consumers will not know how to recognize the early warning signs of these "possible side effects" so they can take appropriate action that would allow them to continue taking the drug.
Is Your Fair Balance Statement
Frightening Consumers?
If your Fair Balance Statement presents risk information in language the consumer cannot understand, you will be scaring the ultimate end user of your product. It does not make any business sense to risk losing your investment in the medication through clinical trials, FDA approval, launch and post-marketing - only to find out later that patients cannot understand the risk information nor the administration instructions.
Many product managers are not aware that an FDA-approved Patient Package Insert (PPI) is an excellent alternative to the traditional risk statements that are developed solely for the DTC ad - and that a PPI will provide the consumer with FDA-approved information about your product in language they can understand.
An FDA-approved PPI will give your product more balanced risk-benefit information because it permits the inclusion of more benefits of the product rather than concentrating solely on the risks. The FDA Draft Guidances recognize the Patient Package Insert as an alternative to the DDMAC requirements for the presentation of risk-benefit information in language that consumers can understand. Since the FDA-approved PPI becomes official patient labeling, the PPI can be used in a multitude of other types of patient/consumer communications.
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