PhRMA is pushing the FDA to expand drug manufacturers’ powers to correct misinformation about their products, including by allowing them to respond to opinions, value judgments or personal experiences and communications made offline.
The trade group made the comments in response to draft guidance the FDA released for consultation in July. The draft proposed two types of responses to misinformation: tailored responsive communications, referring to internet-based messages to address internet-based posts; and general medical product communications, referring to messages that implicitly or explicitly address misinformation using various channels including TV.
The FDA proposed prohibiting companies from posting tailored responsive communications in response to misinformation spread offline and in response to an individual’s posts about their own experience, opinion and value judgments. PhRMA wants the FDA to lift those restrictions.
Responding to the FDA consultation, the trade group said the distinction the draft makes between fact and opinion “is overly simplistic.” The guidance lacks clear definitions of “opinion,” “value statements” or “representations of individual experience,” PhRMA said, and the terms could cover posts that the trade group believes manufacturers should be able to counter using tailored responsive communications.
“Opinions, value statements and representations of individual experience can run the gamut from those that reflect a subjective belief with no implied objective truth or falsity to those that are defamatory to those that are non‐defamatory but still false or misleading,” the trade group said.
As PhRMA sees things, phrasing a statement as an opinion doesn’t prevent the message from being misleading.
PhRMA also targeted the FDA’s exclusion of offline messages from the scope of its tailored responsive communications. PhRMA branded the administration’s position “unduly restrictive,” arguing that “all misinformation is dangerous because it can create public health risks.” The trade group cited TV and streaming as communication formats with broad reach where misinformation can spread.
The rest of PhRMA’s wish list includes the removal of references to “enforcement policy” as the basis or framework for the FDA’s recommendations, the expansion of the scope of medical products covered and confirmation that drug manufacturers can respond to posts by compounding pharmacies and telehealth providers. Weight-loss drugs in particular have made posts by the pharmacies and providers a contentious area.
While PhRMA is asking the FDA to make multiple changes to the draft, it also wants the regulator to move quickly. The trade group noted that the FDA never finalized the earlier draft that it published in 2014. This time, PhRMA is urging the administration to finalize the text promptly after the comment period to avoid the uncertainty that can arise when a document remains in draft for an extended period of time.