Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads

Congress Urges FDA To Adopt Clearer, Neutral Rules For Pharmaceutical Drug Ads

July 11th, 2022 // 9:23 pm @

Several members of the US House, including Katie Porter, who often interrogates pharmaceutical executives on The Hill, wants to force FDA to adopt a proposal from 2010 about some of the distractions that are in direct-to-consumer drug advertisements. The long-delayed proposal would come up with standards that would ensure that pharmaceutical drug risks and important side effects be more prominent and neutral.

Rep. Abigail Spanberger (D-VA) is the congresswoman leading the charge on the legislation known as Banning Misleading Drugs Act. Others pushing the bill are Reps. Katie Porter (D-CA), Susan Wild (D-PA), Cindy Axne (D-IA) and Angie Craig (D-MN). The rule being proposed would focus on the ‘major statement’ that is part of radio and TV pharma ads.

Spanberger stated in a press release that pharmaceutical companies try to hide the side effects of their products with cheerful images, nature, etc. For many in the consumer market, the reps allege, the ads may conceal serious risks that should be considered.

FDA seems to have taken the matter to heart at last and is planning to take action, it would seem. Now, the Clear, Conspicuous, and Neutral or CNN proposal was noted on the spring 2022 agenda for HHS as being in the final rule stage. It also noted that a final decision date is stated for May 2023.

A spokesman for Spanberger noted this week that she had brought the issue forward because she was worried that OMB and FDA delayed the pending rule to May 2023 in their most recent agenda. It was set to be finished this year.

FDA already does regulations of promotions and pharma ads per the FD&C Act which is enforced by the Office of Prescription Drug Promotion or OPDP. OPDP also does research on pharma ad jobs, such as a 2011 study known as Impact of Distraction on Consumer Understanding of Risk and Benefit Information.

FDA found that putting risk-reinforcement text in the major statement enhances how well consumers understand risk information for the drug. But the findings pertaining to sound and visual distractions were not as clear.

When this proposal was released in 2010, industry generally agreed with the agency to make guidelines clearer, but wanted clarifications on some aspects of the proposal. For example, Novo wanted a Flesch-Kincaid Grade Level or related readability scale to detail the reading level needed to understand the ads.

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