The UK's Prescription Medicines Code of Practice Authority (PMCPA), which arbitrates drug industry self-regulation there, last week issued “informal guidance” on digital communications, and while it's more than FDA has offered, it's not much to go on.
, which takes the form of a Q&A, is mainly an interpretation of the industry's Code of Practice applied to social media and the internet. Most of it boils down to this, more or less: No, you can't do that.
As in any other medium, UK companies can communicate only information deemed non-promotional about their products or disease states to the public, and only in response to a direct inquiry. So much for Twitter.
“If a company wanted to promote a medicine via Twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code,” said the Q&A, noting that companies would also have to ensure that recipients had opted into receiving the info. “Given these restrictions and the character limit on Twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code.”
Company-run discussion forums are similarly prohibitively tricky, since the company would be responsible for ensuring that all content, including that generated by users, was compliant. Sponsoring disease awareness sites through third parties via “unrestricted grants” would most likely be frowned upon, said the guidance, and making corrections to Wikipedia pages, beyond referring readers to regulatory documents, would be fraught with danger.
Search engine optimization on company and product names is fine, the guidance said, but linking product and company sites to more general terms, such as disease states, is a no-no.
However, the guidance does suggest that companies could and should post more basic product info, including a summary of product characteristics and PI, public assessment report, medicine guides, disease information, specific medicine information, registration and other studies – on their websites, providing that “the primary purpose of the reference information is to be a library resource for the public.”
administers “at arm's length” the self-regulatory policies of PhRMA's UK counterpart, the Association of the British Pharmaceutical Industry, and liaises with EU and UK regulatory agencies.