Today, the Congresswoman Led the Introduction of Legislation to Block Pharmaceutical Companies from Distracting from Dangerous Side-Effects in their Commercials
WASHINGTON, D.C. — U.S. Representative Abigail Spanberger today led the introduction of legislation that would protect seniors, prevent drug manufacturers from obscuring dangerous side effects of their prescription drugs in their advertisements, and help consumers make informed decisions.
The United States and New Zealand are the only countries in the world that permit direct-to-consumer pharmaceutical advertising — and there are serious consumer safety concerns around the proliferation of these ads. Frequently, the ads supplant the knowledge and judgment of physicians in determining whether a drug is most suitable for a particular medical condition. Studies show that an ad’s use of visuals when discussing the side effects of a drug distracts American consumers from the risks.
To address these concerns, Spanberger’s 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 of the major statement.
“Virginians have seen the commercials — they’ve seen how pharmaceutical companies try to mask their products’ side effects with butterflies, cheery music, and beautiful sunrises. For many consumers — especially seniors, these ads can hide the very serious risks that come with certain drugs,” said Spanberger. “Critical medical decisions should always be made between a patient and their doctor — not between a patient and their television screen. I’m proud to introduce legislation that pushes the FDA to finalize a rule that has been delayed for more than a decade. We need to give patients the clear information required to make informed decisions about their health, and my bill would make sure pharmaceutical companies don’t shy away from the truth.”
Spanberger’s 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 requires FDA to draft and finalize within 30 months of passage standards determining how side effects can be presented in pharma ads. FDA has now missed that deadline by more than a decade.
Spanberger introduced the legislation alongside U.S. Representatives Susan Wild (D-PA-07), Cindy Axne (D-IA-03), Katie Porter (D-CA-45), and Angie Craig (D-MN-02).
“Americans deserve the truth about their medications – especially when it comes to potentially dangerous side effects. But for far too long, drug companies have used deceitful advertising tactics to distract consumers from the potentially harmful reactions to their products,” said Craig. “I’m proud to join my colleagues in introducing this long-overdue legislation to provide transparency around prescription drugs and ensure that Big Pharma does not mislead the public.”
“Big Pharma has tried every trick in the special interest playbook to deceive Americans for profit, including in their ads,” said Porter. “Congress has a duty to protect patients. I’m proud to co-lead this overdue legislation that will help keep Big Pharma’s advertising in check.”
“Pharmaceutical companies employ a host of misleading marketing tactics to prop up their bottom line, regardless of the impact on health outcomes of patients,” said Wild. “I am proud to co-sponsor the Banning Misleading Drug Ads Act to prohibit companies from using questionable strategies to distract from side effects of the products they are pushing.”
Spanberger’s 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.
“We applaud Reps. Spanberger, Porter, Craig, and Wild for introducing this important legislation. For too long, Big Pharma has used deceptive advertising to further pad their already sky-high profits. Consumers deserve better. We urge Congress to pass this legislation – and broader prescription drug reform – to finally rein in the out-of-control big pharmaceutical corporations,” said Margarida Jorge, Campaign Director, Lower Drug Prices Now.
“For more than a decade, the FDA has flouted the will of Congress by failing to finalize a rule requiring direct-to-consumer prescription drug TV and radio ads to provide clear and balanced descriptions of the drugs’ major risks, which was mandated by a 2007 federal statute,” said Dr. Michael Carome, Director, Health Research Group, Public Citizen. “The Banning Misleading Drug Ads Act of 2022 would rectify the agency’s troubling inaction and finally ensure that consumers are not mislead by ads that cleverly downplay the risks of prescription medications.”
“An estimated 65 million Medicare beneficiaries rely on Congress to ensure patient safety and protect consumers from misleading advertising tactics by prescription drug manufacturers,” said Richard Delaney, Chairman, The Senior Citizens League (TSCL). “We support legislation that helps keep ads honest by endorsing the Banning Misleading Drug Ads Act of 2022.”
Medicare and its beneficiaries spent more than $324 billion on drugs advertised to consumers from 2016-2018 — more than half of all Medicare spending on drugs during that period. Additionally, direct-to-consumer advertising accounts for nearly one third of America’s rapid increase in prescription drug spending.
The Banning Misleading Drug Ads Act would require the FDA to finalize the regulation (docket No. FDA-2009-N-0582; RIN 0910-AG27) within 180 days of passage. Otherwise, the bill deems the 2010 Notice of Proposed Rulemaking as the final rule. That proposed rule would clarify that drug ads must include a statement related to side effects, contraindications, and effectiveness and disallow presentations that distract from the statement.
Click here to read the full bill text.