Bill to Restrict DTC Ads Introduced in House Committee

An act to restrict direct-to-consumer (DTC) advertising was recently referred to the House Committee on Energy and Commerce.

Introduced by US Representative Rosa DeLauro (D-Connecticut), the “Responsibility in Drug Advertising Act” (HR 4565) would amend the Federal Food, Drug, and Cosmetic Act to restrict DTC advertising.

The current language of HR 4565 stipulates that a drug’s sponsor cannot conduct DTC advertising within 3 years of the drug’s FDA approval. After the 3-year moratorium, the Secretary of the US Department of Health and Human Services could still prohibit DTC advertising if he or she “determines that the drug has significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, and clinical or observational studies, or any other appropriate source,” according to the bill.

Notably, the bill’s language also provides the possibility to obtain a waiver for the moratorium if the drug in question is a breakthrough therapy considered to have “affirmative value to public health.”

“This legislation puts reasonable safety restraints on…[DTC] drug marketing,” said Connecticut State Comptroller Kevin Lembo and Rep. DeLauro in a joint press release. “Prescription drug sales should be driven by thoughtful health care decisions between patients and their providers, not by…drug marketers.”

While the American Medical Association has called for a DTC advertising ban, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserts that the ads increase awareness of diseases in general and their available treatments.

“Studies show DTC advertising brings patients into their doctors’ offices and starts important doctor-patient conversations about health that might otherwise not take place,” PhRMA asserted in its guidelines on pharmaceutical advertising.

Currently, federal law does not require the FDA to approve advertisements before they are released to the public, although the agency can investigate claims that broadcasted drug information is false or misleading.

DTC ads for the OTC allergy treatment Nasonex were the subject of a study alleging that when the ads listed benefits, the images on the screen matched the voiceover and moved slowly, but when the side effects were listed, the images often became mismatched and the text was distracting. However, the FDA ultimately concluded that the tone and consistency of background images did not impair viewers’ understanding of the risk information.

Regardless of the bill’s future, pharmacists are in a great position to educate patients on the benefits and risks of the medications they see advertised on television.

The United States and New Zealand are the only countries that currently allow DTC advertising. The European Union recently voted to uphold its ban on DTC ads.