Proposed legislation takes aim at prescription drug advertising

Regulatory NewsRegulatory News
| 11 July 2022 | By Joanne S. Eglovitch 

New legislation recently introduced in the House of Representatives would direct the US Food and Drug Administration (FDA) to finalize a long-dormant final rule requiring pharmaceutical manufacturers to include a statement on drug labeling warning of a drug’s risks and side effects “in a clear, conspicuous, and neutral manner.”
 
The Banning Misleading Drugs Act, introduced by Rep. Abigail Spanberger (D-VA) on 5 July, would require 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 would prevent advertisements from including ‘distracting representations’ – including statements, text, images, or sounds – that detract from the communication of the major statement,” said a press release from Spanberger’s office.
 
“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.”
 
Direct-to-consumer prescription drug advertising is only permitted in the US and New Zealand, and frequently take the place of a physician’s knowledge and judgment of a drug’s suitability, said Spanberger’s office. Studies also show the use of visuals when discussing a drug’s side effects “distracts” consumers from these risks.
 
The legislation was also co-sponsored by Reps. Susan Wild (D-PA), Cindy Axne (D-IA), Katie Porter (D-CA) and Angie Craig (D-MN).
 
The legislation was supported by several groups, including Public Citizen. “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,” Michael Carome, director of Public Citizen’s health research group, and added the legislation “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.”
 
A senior citizens group also supported the proposed legislation. Richard Delaney, chair of the Senior Citizens League, estimated that 65 million Medicare beneficiaries depend on consumer protection against misleading advertising tactics. “We support legislation that helps keep ads honest by endorsing the Banning Misleading Drug Ads Act of 2022.”
 
If signed into law, the bill would direct FDA to issue a final rule within six months its enactment.
 
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