The UK’s Prescription Medicines Code of Practice Authority (PMCPA) issued its final resolution in its case against Moderna that pertained to four tweets, two articles and participant information sheets the US pharmaceutical and biosciences company had published online for a Moderna-sponsored clinical trial.

All of the communications referred to the recruitment of participants for a clinical trial evaluating Moderna’s COVID-19 vaccine, with the tweets and the articles not being subject to the required regulatory approval process, the PMCPA said.

The complaint also alleged the use of the word “safe” was misleading in the participant sheet and an informed consent form for that clinical trial, and it alleged the company was not sufficiently clear as to its own role and involvement. The agency also noted that all claims and information in these comparisons should be capable of substantiation, and said some of Moderna’s data points in the materials were not.

There was an appeal by the complainant of seven of the PMCPA panel’s breach rulings; several of them were successful in full or in part.

Specific concerns

The PMCPA included a number of examples of the complaints undergirding its investigation into this matter and its specific charges, including the following:

• Phrases such as “Hurry,” “Call now,” “Don’t miss out,” “Places filling fast,” and “Enrollment limited,” were not permissible.
• When the trial is paid, the payment can be mentioned, but it should not be emphasized through prominent placement, larger or bolder type or other devices such as flashing fonts. And specific compensation should not in general be mentioned in recruitment material aimed at pediatric populations.
• Where a third-party recruitment company is recruiting on behalf of a sponsor and/or research site, the name and address of the research site and/or sponsor should be included.
• If stock photos of people are used in recruitment materials aimed at residents of New Zealand, efforts should be made to ensure they are representative of the New Zealand population.

Third-party oversight

The PMCPA’s case summary expresses several concerns, with a primary one being Moderna’s level of oversight over third parties.

According to the Association of the British Pharmaceutical Industry’s (ABPI’s) Code for the Pharmaceutical Industry, a pharmaceutical company is responsible for all material disseminated and activities carried out by it on any social media channel that comes within the scope of the ABPI Code, including by a third party acting on its behalf even if that third party acts beyond the scope of its contract, and potentially material/activities sponsored by it.’

PMCPA cited in its complaint resolution examples of tweets that had a photograph supplied by a vendor featuring a schoolgirl with a teddy bear and certificate of participation in a COVID-19 vaccine trial with language encouraging children to take part in it.

The PMCPA said “it reflected poorly on the industry” and that, in combination with other problematic tweets and a linked article, resulted in the pharma company bringing “discredit upon and reducing confident in the pharmaceutical company.”

And the PMCPA noted that Clause 1.24 of the 2021 Code states that companies are responsible under the Code for the acts and omissions of their third parties which come within the scope of the Code, even if they act contrary to the instructions which they have been given.