- Those latching on to the story to decry FDA’s involvement in the gathering better take note.
- Wash.Post article casts FDA-drug maker interactions in a sinister light. But it doesn’t provide much context.
- FDA is greatly constrained in how it can hold meetings, and especially in its ability to pay for them.
The Washington Post has a story today about an alleged “pay to play” scheme where FDA supposedly collaborated with branded drug makers to shape regulatory policy at private meetings that the drug makers had paid to attend.
The article casts the interactions in a sinister light. But it doesn’t provide much context. Without knowing much about the particular meeting that the Washington Post profiles (it seems the Washington Post didn’t know much about the meetings either, or at least didn’t take space to inform readers about specific content and goals) let me offer some perspective.
According to the Post, the meetings were of an ad hoc scientific panel, convened by a group of academicians and drug makers, to shape “the federal government’s policy for testing the safety and effectiveness of painkillers.”
The article says that the meetings were “funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration,” according to e-mails that the newspaper obtained. Based on my own perusal of some relevant web sites, it seems that the meetings concerned FDA’s ongoing discussions about how to tighten restrictions on narcotics and create a framework for the review of a new class of drugs that have less abuse potential than existing medicines.
Meetings of this nature are not unusual. They span multiple political administrations and FDA Commissioners. They happened during the Bush and Clinton Administrations and continue today.
The fact remains that somebody has to pay for a scientific meeting. It usually ends up being the participants with the deepest pockets that get hit up.
In a nutshell, FDA can’t easily convene experts to engage in discussions on broad scientific issues and regulatory principles. FDA is greatly constrained in how it can hold meetings, and especially in its ability to pay for them.
So it’s not uncommon to see agency scientists attend meetings convened by private organizations. This is especially true when it comes to public-private collaborations (similar to the meeting in question by the Washington Post) where regulated companies will work with academic groups to put together seminars, working groups, and other kinds of clinical forums. In this case, the group was organized by two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington
Consumer groups are crying foul today based on the Washington Post reporting. But it’s probably the case that every major step FDA has taken over the last decade to tighten its safety requirements around drugs (steps applauded by these same groups) was shaped, in some fashion, by FDA’s dialogue with outside clinical forums that looked like the one profiled by today’s Washington Post. Most (if not all) of these gatherings were at least partially funded by companies who had a stake in the outcome.
In many cases, these kinds of gatherings have tight governance that puts academic leaders or professional societies in charge of content. They are sometimes open to the public, or invite public advocates to participate in discussions.
Those latching on to the story to decry FDA’s involvement in the gathering better take note. Much of the agency’s ability to interact with the broader scientific community, inform its work, and shed some transparency around its deliberations stems from its willingness in recent years to engage in these sorts of gatherings.
The FDA can (and often does) demand certain measures of governance around gatherings where it joins. Often times, it asks for an obligation to make meetings open or report findings and conclusions. Moreover, for the last few years, FDA has been unusually candid about its regulatory work to shape guidance for the review of a new class of narcotics. It’s hard to believe anything fashioned in this meeting was not communicated widely.
To indict the practice of FDA participating in these sorts of public-private seminars could make the entire regulatory process far more insular, and a lot less transparent.