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Sleep pill ad targets kids; FDA takes months to act

Tuesday, March 13, 2007

Sleeping Pill Advertisement Targeting Children Illustrates Need for Congress to Reform Prescription Drug Ads

FDA took six months to request company to cease back-to-school ad

(Washington, D.C.) – Consumers Union today urged Congress and the Food and Drug Administration to support major changes to direct-to-consumer advertising of prescription drugs after it took the agency more than six months to ask a drugmaker to cease ads that suggest sleeping pills are indicated for children.
“This advertisement geared to children going ‘back to school’ is outrageous, and we urge the FDA take stronger and more timely actions in cases such as this,” Bill Vaughan, senior policy analyst, wrote in a letter today to FDA Commissioner Andrew von Eschenbach.
“It appears from the FDA letter that the advertisement in question ran in early September. We suspect that since it refers to ‘back to school,’ that the ad has not been used for some months,” Vaughan wrote. “Asking the company to stop running a ‘back to school’ ad in March is less than a slap on the wrist—it is embarrassing. The company should be subject to a requirement for corrective advertisements to warn parents that this product may be both ineffective and dangerous in children.”
The FDA sent a letter March 5 to Takeda Pharmaceuticals, maker of the sleeping aid Rozerem, to cease the dissemination of promotional materials for the drug featuring school children. To read a copy of the FDA letter,click here. To see samples of the ad, click here.
The TV ad, which ran in September 2006, stated:
“Rozerem would like to remind you that it’s back to school season. (visuals include chalk boards, school books, school bus, laptops, school-aged children with backpacks). Ask your doctor today if Rozerem is right for you.”
The FDA wrote that the TV ad was “especially concerning” since the drug includes a precaution for pediatric use that, “Safety and effectiveness of Rozerem in pediatric patients have not been established,” and that it has been associated with an effect on reproductive hormones.
Vaughan said the fact the drugmaker ran such an ad targeting children, as well as the six-month plus delay in the FDA’s acting on it, indicates that the agency’s drug safety system is broken and in need of reform.
“We hope that the FDA will support legislation now being considered in Congress to add language that will strengthen the requirements for timely, mandatory pre-approval of ads, civil monetary penalties for violations, especially repeat violations, and the more frequent placement of corrective ads so as to prevent the type of abuse seen in this case.”
To read a copy of Consumers Union letter to the FDA, click here.
The Senate Health committee Wednesday will take up reauthorization of the Prescription Drug User Fee Act (PDUFA), which calls for the drug industry to pay $393 million annually to the FDA to help fund the drug-approval process. Critics say having industry fund the same agency that regulates it is a conflict of interest that has led to many drugs with questionable safety problems being rushed onto market, and has prompted lax regulation of drug safety.
A provision in PDUFA calls for drug companies to also fund FDA pre-clearance of prescription DTC ads, but the program is purely voluntary.
“A voluntary program that lets the drug maker decide if they want their advertisement cleared will change nothing. We can just expect more of the same, ads that play up the positives and downplay very real risks and side effects,” Vaughan said.

Bill Vaughan, Susan Herold, 202-462-6262