Over the Counter, Under the Microscope
Suppose you’re the director of marketing in the consumer division of ABC Pharmaceuticals, which makes prescription and over-the-counter drugs. You’ve been asked to develop a promotion for an OTC brand, Cold EZ, to run during cold season.
Your idea is an essay contest on how Cold EZ saved the day for a cold sufferer. Judges will award first, second, and third prizes; winning essays will appear in future ads and p.r. efforts.
You want to do general advertising and send contest information to everyone who got info on ABC’s last promotion.
You know how to put together a contest, but this is your first work in pharmaceuticals. ABC’s general counsel should give you this advice:
Testimonials
You must ensure that winning essays describe experiences that are typical for Cold EZ users. The basic ad rule — that testimonials must reflect average consumer experience (unless the claim’s atypical nature is well disclosed) — is even more important for pharmaceuticals because the FDA (for prescription drugs) and FTC (for OTC drugs) strictly enforce health-related product claims. If ABC’s stories describe atypical experiences, the FTC might charge the company with making unsubstantiated claims.
Off-Label Promotion
The winning essays also must only share details consistent with product claims on Cold EZ’s label or the FDA might chastise you for making “off-label” claims. A contestant may write that Cold EZ immediately cleared up her stuffy nose, but if the package doesn’t promise immediate relief, the claim is risky. Essays also can’t exaggerate product benefits, so you should reserve the right to edit the winners. Make sure the contest rules, affidavit of eligibility, and winners’ release give you the right to edit — but don’t change the substance of the stories.
Public Image
ABC has spent millions of dollars building its image as an honest, responsible corporate citizen. You need to make sure the winning essays don’t contradict that. You may have to edit out references to reckless behavior, drug or alcohol use, or sexual activity.
Adverse Consequences
Some contestants may describe ill effects, or “adverse consequences.” You may have to report those to the FDA, so have personnel familiar with pharmaceutical reporting requirements review all essays.
Eligibility Concerns
Make sure the contest is only open to consumers who used Cold EZ before the promotion began. That way, ABC isn’t inducing anyone to use Cold EZ just to vie for a prize. (If Cold EZ were a prescription drug, ABC could be subject to the federal anti-kickback law, which prohibits anyone from giving something of value to influence the referral of a patient for any item or service reimbursed by Medicaid or Medicare. That’s a felony.)
It’s a good idea to make doctors ineligible for the contest, even though Cold EZ is OTC. That would be consistent with American Medical Association guidelines calling for gifts to physicians to benefit patients and not be of substantial value. Cash or a valuable prize unrelated to the doctor’s practice are inappropriate for prescription drugs, and OTC promos should consider that, too.
Privacy
Make sure your contact with past promotion participants is consistent with ABC’s privacy policy and other confidentiality obligations.
Notification
Comply with the notification and opt-out provisions of the Deceptive Mail Prevention and Enforcement Act. This 22-month-old law covers all direct-mail sweepstakes and contests, and requires mailings to tell consumers they can opt out of future mailings. Have a system to process opt-outs, and vet your list before any mailing to be sure all opt-outs have been removed.
Let the contest begin.
Terri Seligman is a partner in the advertising and promotions group at Loeb & Loeb, New York City. Reach her at [email protected].
