Advertisements don't always tell the full story about pharmaceuticals.

RODALE NEWS, EMMAUS, PA—The U.S. Food and Drug Administration (FDA) is cracking down on misleading pharmaceutical ads that can confuse consumers and could ultimately hurt them. While warning letters to drug makers have more than doubled since President Barack Obama's administration moved into town, there are still regulatory gaps that keep the responsibility to research prescription drug safety squarely on the shoulders of consumers. Thomas Abrams, RPh, MBA, director of the FDA's Division of Drug Marketing, Advertising, and Communication, credits the increase in oversight to orders from new FDA Commissioner Margaret Hamburg, MD, to streamline processes within the agency and bulk up support for enforcement of drug-advertising laws.

THE DETAILS: While the FDA has no control over the amount of money drug makers dump into advertising campaigns, the agency does review pharmaceutical promotional materials, including TV and magazine advertisements, drug websites, ads in medical journals, mailers, brochures, and even the freebies pharmaceutical reps shower doctors with during in-office drug presentations (yes, this includes everything from erectile-dysfunction-drug pens to STD-fighting-drug notepads). The problem is, consumers often are seeing these ads before, or in a best-case scenario, at the same time, as the FDA reviewers. "If a TV ad goes on the air tonight, it has to go to FDA today," explains Abrams. "Except in unusual instances, we cannot require drug companies to submit ads for approval before they are used. Drug companies must only submit their ads to us when they first appear in public."

In essence, this means consumers may see ads violating the law before the FDA can stop the ad from appearing. Abrams' office reviews about 72,000 pieces of drug promotional materials a year, and its reviews are risk-based. That means the FDA looks at ones that could impact public health most significantly first. (As a side note, the FDA does not monitor ads for over-the-counter medicines. That falls under Federal Trade Commission enforcement.)

WHAT IT MEANS: Contrary to popular belief, drug companies can practice direct-to-consumer marketing tactics even for drugs that can cause life-threatening side effects or even death. So it's important that you don't equate the actors' smiling faces with complete safety. For instance, FDA recently sent a warning letter to Abbott, the manufacturer of the HIV drug Kaletra, for a patient-testimonial DVD fearing Magic Johnson that allegedly overstated efficacy, downplayed risks associated with the drug, and made unsubstantiated claims. Abrams says generally the FDA letters warn companies for common infractions like minimizing the risk information, pumping up the effectiveness of the drugs, and engaging in off-label promotion, that is, recommending the drug for ailments it hasn't been approved for. If companies don't take action to fix their unlawful advertising and tell the FDA they've done so within 10 days, FDA can take further action, although, Abrams says, drug companies generally comply.

Read on to find out how you can ID and outsmart drug companies' advertising gimmicks.