DES MOINES, Iowa – U.S. Rep. Cindy Axne, D-Iowa, joined four of her Democratic colleagues on Tuesday to introduce a bill to prevent drug manufacturers from obscuring potential side effects of their products to help consumers make informed decisions.
The United States and New Zealand are the only countries that permit direct direct-to-consumer pharmaceutical advertising. However, Axne states that there are serious consumer safety concerns around the proliferation of these ads.
Axne claims the ads frequently supplant the knowledge and judgment of physicians in determining whether a drug is most suitable for a particular medical condition. In a press release, her office also states that studies show that using visuals when discussing a drug’s side effects distracts American consumers from the risks.
The Banning Misleading Drug Ads Act would require the U.S. Food and Drug Administration (FDA) to finalize a 15-year-old proposed rule clarifying that drug ads must include a statement related to side effects, contraindications, and effectiveness — while also prohibiting distractions from neutral information. If enacted, this rule would prevent advertisements from including “distracting representations” — including statements, text, images, or sounds — that detract from the communication about the potential side effects.
The legislation addresses a delayed rule that has been sitting on the FDA’s shelf for years. The bipartisan Food and Drug Administration Amendments Act of 2007 required FDA to draft and finalize within 30 months of passage standards determining how pharmaceutical ads present side effects. FDA has now missed that deadline by more than a decade. This legislation requires that the FDA finalize that rule within 180 days and would implement the proposed rule if they do not.
“Consumers deserve to know exactly what they’re getting when it comes to their medications, yet drug companies have been allowed to deceive their customers through predatory advertising practices that shroud critical information– placing the health and safety of patients at risk,” Axne said. “This bill will put a stop to that malicious practice while empowering patients with the information they need to make healthy decisions.”
The Banning Misleading Drug Ads Act is endorsed by the National Center for Health Research; Lower Drug Prices Now Coalition; Patient, Consumer, and Public Health Coalition; Public Citizen; National Women’s Health Network; Center for Science in the Public Interest; and The Senior Citizen’s League.
This past January, Axne introduced legislation to end taxpayer subsidies for prescription drug advertising. She said the Banning Misleading Drug Ads Act is her next step in holding pharmaceutical companies accountable to patients.