Hobby Lobby is just the most recent example of the First Amendment on the move. As we’ve seen before, the First Amendment is a favorite deregulatory tool of the conservative majority in the US Supreme Court.
So if we take that as a given, what are the implications for the FDA? How do they ensure that (only) high-quality data are disseminated to physicians and the public? (This sounds like a mission statement for research-based blogging)
The rules restricting off-label promotion of drugs are in the cross-hairs, and the FDA has reacted by backing off in recent guidance documents. The FDA has given up on actual rules, but is just issuing safe harbor guidance. Here are the practices the FDA prefers (but doesn’t mandate):
In the recent guidance documents, the FDA recommended that scientific articles used for off-label promotion be scientifically sound, come from peer-reviewed journals, and be distributed in unabridged form with the approved labeling and a comprehensive bibliography. Clinical practice guidelines used for marketing should be based on a systematic review of the evidence and “be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups.” The FDA also recognized the growing importance of social media, describing the situations in which a company is responsible for comments on Facebook and patient-advocacy websites focusing on specific diseases and treatments. In early June, the FDA expanded this guidance process to include communications about new risk data for existing drugs. The FDA is concerned that companies might use incomplete new information to weaken the impact of warnings on the approved drug label. (my Perspective from this week’s NEJM)
Clinical trials transparency is an available tool that raises no First Amendment issues. Europe is moving towards much more transparent disclosure of the Clinical Study Reports on approved drugs and access to anonymized patient-level data so independent research groups can re-evaluate the data with different methodologies and statistical tools.
The goal will be to drive out the bad information with high-quality data, created by the companies themselves, but currently hidden from researchers and the public.
The full article & and audio interview are ungated at NEJM.
@koutterson
