Little did the FDA know that allowing drugmakers to hand out medical-journal articles to doctors would be so controversial. After talking about the idea for years--since 2007, at least--the agency rolled out some guidelines last June that would govern the practice. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.
In a letter released Wednesday, Public Citizen called on Health and Human Services chief Sylvia Burwell to abandon the idea completely. Letting reps distribute studies that contradict the FDA's own official label warnings? That's granting pharma companies a license to promote their meds as safer than the agency's experts have deemed them to be.
The letter caps an official public-comment period the FDA opened when it unveiled the proposed guidelines. Public Citizen got copies of those comments--some 1,771 of them, the group says--via an open records request, and then made them publicly available.
As the organization's top dog, Sidney Wolfe, points out, 99% of those comments opposed the proposal. The 11 comments supporting the idea came from pharma companies and one academic researcher, the group said in a statement.
Among Public Citizen's own beefs: The proposal would allow companies to hand out journal articles without any prior review by the FDA. The articles would have to be from peer-reviewed journals, but many of those publications cover pharma-sponsored studies, Public Citizen points out.
The FDA hasn't acted on those comments, and doesn't have a set timeline for deciding whether to revise its proposed rules for article distribution, keep them as is, or punt them altogether. For now, the agency says it's sifting through the feedback it has received. "Secretary Burwell appreciates hearing from stakeholders," a spokesperson told Reuters. "The FDA is currently reviewing and considering all comments received from the dockets on the draft guidance."
Drugmakers have argued that new data changes the picture on recently launched products. Under a law passed in 1997, drugmakers could distribute journal articles that support uses that weren't approved by the FDA, but that law expired in 2007. That's when the agency proposed its own rules.
Since then, the argument has heated up. On the one hand, drugmakers have paid billions in fines and civil penalties for pushing their drugs for unapproved uses, and for depicting their meds as safer and more effective than they might actually be. On the other, appeals courts have issued some rulings that suggest the First Amendment protects sales reps--individually, at least--who talk about off-label uses for drugs. And in a whistleblower suit in California--part of which centered on distribution of journal articles--PhRMA argued that the sales reps in question were exercising their free speech rights. The Justice Department, however, wasn't convinced.
Last year, several FDA officials--including chief counsel Elizabeth Dickinson and Center for Drug Evaluation and Research chief Janet Woodcock--made some comments about the agency's reviewing policies in light of those free speech rulings.
PhRMA, the industry's Washington-based lobby group, has backed the idea of distributing info about off-label use--obviously enough. It's supporting the FDA's guidelines now. What the agency will do next about the proposal is anybody's guess.
- see the release from Public Citizen
- read the Reuters news