Barbara Wills

Fujisawa's Prograf (tacrolimus) is a good example of a brand with an effective patient compliance strategy. The brand team first developed FDA-approved official patient labeling and then used that language to craft the subsequent product-specific materials. The team also developed disease awareness programs, consumer decision-making programs, and websites, which are practical, understandable, and motivational for transplant patients.

However, what distinguished that company's program was the "Sharing Your Experiences: Transplant Mentor Program," which trains volunteers to become mentors to patients who are awaiting transplants and living donors. This program was built on the premise (unearthed through research) that transplant patients find it helpful to speak with someone who understands the medical, emotional, and financial concerns of the transplant process.

Neal Fitzpatrick

Risk Information or the PPI FDA places great importance on ensuring that patients have understandable and readable risk information—and given its role in patient compliance, the industry sees eye to eye with the agency. To help move those initiatives along, the FDA issued draft guidances that gave pharma companies an option: replace the brief summary with a more condensed version that concentrates on the risk information or with official patient labeling.

The FDA notes that risk information "must include all warnings, the major precautions, including any that describe serious adverse drug experiences or steps to be taken to avoid such experiences; and the most common nonserious adverse reactions most likely to affect the patient's quality of life or compliance with drug therapy."

However, if executives take a patient-centric approach, the question becomes, "Is the presentation of risk information enough?" After all, including just the risk information does not provide patients with enough information to weigh the benefits against the risks.

Instead, marketers should substitute the brief summary with a PPI, a one-page, consumer-friendly version that is based on the package insert. A PPI presents risk-benefit information in "fair balance" and gives additional information such as behavior modification techniques that will help motivate patients to stay on their therapy. It also addresses the major risk to patients of not taking the drug and dropping out of their treatment prematurely.

That's akin to going to a surgeon and learning that your leg needs to be amputated. If the surgeon told you only the risks associated with the procedure, and not why the surgery was necessary, then chances are, you wouldn't agree to it. Similarly, patients need to know that they are risking a heart attack by not taking their medication. Once they have this information, they can weigh the benefits against the risks, and then decide what to do.

Although the FDA encourages companies to use PPIs, there is no mandate to use them. As a result, some companies continue to use the brief summary on the back of their print DTC ads because they believe it is easier and cheaper than translating the professional labeling into consumer-friendly language—and making the language acceptable to the company's legal, regulatory, medical, and marketing teams as well as FDA. However, other companies find the effort worthwhile and submit PPIs as part of the new drug application or as a supplemental new drug application. Once approved, the PPI can be used in place of a print DTC ad's brief summary and as part of any educational material for patients and consumers, including collateral materials, websites, patient videos, starter kits, and compliance packaging.