FDA relaxes EUA advertising limitation for some COVID drugs

Regulatory NewsRegulatory News | 16 November 2022 |  By 

The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs). The agency said that “truthful and non-misleading” advertising and promotion of COVID-19 therapeutics could benefit the public health, though some caveats to how the drugs can be promoted still apply.
In a memorandum dated 27 October, first reported by AgencyIQ, FDA laid out a new policy giving sponsors of EUA products more leeway to promote their products. Unlike drugs and biologics that are approved via traditional pathways, when issuing an EUA, FDA can place conditions on advertising and promotional materials that relate to a drug’s emergency use.
Throughout the pandemic, FDA had included a condition in the letter of authorization for all COVID-19 therapeutics that prevented firms from disseminating “printed matter, advertising, or promotional materials” related to the authorized therapeutic that suggest that the drug is “safe or effective” when used for the authorized emergency use.
Now, FDA has revised that condition for six specific products: baricitinib, Actemra (tocilizumab), Evusheld (tixagevimab co-packaged with cilgavimab), Paxlovid (nirmatrelvir and ritonavir), Lagevrio (molnupiravir) and bebtelovimab. Under the new condition, FDA states that the products may be promoted with “accurate descriptions of safety results and efficacy results on a clinical endpoint(s) from the clinical trial(s) summarized in the authorized labeling.”
The agency goes on to state that the promotional materials “must include any limitations of the clinical trial data as described in the authorized labeling” and that the companies may not imply that their products are FDA approved or safe and effective for the authorized emergency use. Additionally, the agency will require EUA holders to submit any such promotional materials for review at least 14 calendar days before they are disseminated or used.
“While the authorized labeling for an EUA should serve as the primary resource for information on the authorized product, dissemination of truthful and non-misleading printed matter, advertising, and promotional materials containing scientific information related to the authorized use of the product, when consistent with the terms and conditions of the respective authorization, can further enhance the public’s awareness of and understanding on the authorized COVID-19 therapeutic,” FDA wrote.
“Although EUAs aren't new, their issuance has exploded during the current pandemic,” Dale Cooke, president of PhillyCooke Consulting, told Focus. “Advertising and promotion of these products is clearly permitted by the law, but FDA has wide latitude for imposing restrictions on this activity.”
Cooke said that FDA faced a conundrum, as sponsors need to provide healthcare professionals and patients with information about EUA products, but the agency has not yet developed guidance on what that looks like within the limitations of the law. He said the recent memo is the agency’s attempt to provide more information on the topic and could be the basis for a future guidance.
“FDA is fleshing out its interpretation of what it means to provide information about these products without violating the requirements to avoid suggesting the products are safe and effective prior to their approval,” said Cooke. “In addition, by requiring that all materials be submitted 14 days prior to use for advisory comments, FDA is showing that it wants to provide input to sponsors before they communicate with the public rather than primarily relying on enforcement actions after the fact.
“That seems like a sensible approach given that taking enforcement against a company for inappropriate actions when the product is only authorized under an EUA could cause undue concern among the public about whether the product should be used as the sponsor is suggesting in its promotional communications,” he added.


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