FDA Should Ban Direct-to-Consumer Prescription Drug Advertisements

The U.S. Food and Drug Administration (FDA) should ban direct-to-consumer (DTC) advertising of prescription drugs, Public Citizen said today in a petition filed with the agency. Banning DTC ads would align U.S. policy with international best practices, protect the public from misleading and harmful drug promotion, and promote rational, evidence-based prescribing.

“DTC ads often mislead consumers because they are designed to persuade rather than to inform or educate patients,” said Nina Zeldes, PhD, health researcher for Public Citizen and lead author of the petition. “These ads typically employ emotional manipulation techniques and visual distractions to highlight information about a drug’s benefits while minimizing its risks. When DTC ads work, they do so by interfering with the doctor-patient relationship – persuading physicians to prescribe medications they otherwise would not have prescribed.”

A large body of peer-reviewed evidence demonstrates that DTC ads:

• Misleadingly present the benefits and risks of medications, distorting patients’ understanding of drug safety and effectiveness;
• Use favorable and selective imagery to manipulate consumers’ emotions;
• Contribute to the overdiagnosis of disease and overprescription of medications;
• Erode the patient-physician relationship;
• Promote low-value medications and medications with uncertain benefits and harms; and
• Harm the economy and the health care system.

Because DTC advertising is often misleading and because prohibiting it would advance a substantial government interest, a ban would comply with the First Amendment, according to the petition. Greater enforcement of existing regulations, with uncertain effectiveness, is not an adequate substitute for a new rulemaking. Warning letters simply react to violations that have already occurred; they do not constitute a proactive approach to remedy the harms of DTC advertising.

“The harms of DTC ads outweigh any supposed benefits,” said Robert Steinbrook, MD, Health Research Group director at Public Citizen and an author of the petition. “Now is the time to advance public health by banning these ads.”

Nearly all other developed nations, including Canada, Australia, the United Kingdom, and those of the European Union, have long prohibited DTC advertising for prescription drugs that include medical claims. Only two developed countries, the U.S. and New Zealand, allow unfettered DTC advertising of prescription medications. There is no evidence that consumers in countries that ban DTC advertisements suffer any adverse health effects.