The FDA’s recent proposal to allow drug companies to send doctors journal articles about off-label drug use has come under major fire over the last few months.
Back in April, The New York Times, in a news feature in its business section (F.D.A. Plan on Medical Articles Takes More Heat), highlighted the widespread opposition to the proposal. This opposition came from, among others, Public Citizen, New York State’s health commissioner, Representative Henry Waxman (who sent a letter to the FDA outlining his concerns), and the Blue Cross Blue Shield Association, a trade association of 39 major health insurance plans. Needless to say, the pharmaceutical industry supports the proposal.
The proposal includes a set of principles that drug companies are supposed to follow, such as only sending doctors articles that have been peer-reviewed. As Randall Stafford (Stanford University) points out, there are two particularly striking things about the proposal:
“First, manufacturers need no longer limit their promotion of off-label uses to drugs and indications for which they are working toward FDA evaluation; and second, there is no requirement for advance FDA review of the journal articles to be distributed.”
But given that off-label prescribing is widespread in the US, what could be the harm of simply allowing drug companies to promote more of it? That’s a question answered by Andy Gass (University of California Berkeley) and Jennifer Wilson (University of California San Francisco) in a recent editorial in the American Journal of Bioethics (Disclosure: Andy used to work at PLoS as our outreach coordinator).
The authors lay out four potential harms.
First, they say, the selection of articles distributed to physicians by industry is likely to be biased.
Second, “the requirement that information passed on by industry be limited to peer reviewed journal articles may do little, in practice, to ensure the scientific quality of the evidence contained therein.” Or, as Joseph Ross (Mt Sinai School of Medicine), author of a JAMA study on ghostwriting in trial reports on rofecoxib, told the New York Times: “What does it mean to be peer-reviewed… if the company has essentially conceived the article, composed the draft and written the paper?”
Third, say Gass and Wilson, a rapid proliferation of off-label prescriptions, which might plausibly follow from a rapid proliferation of off-label marketing to physicians, could make it more difficult to track drug safety.
Finally, they say, the omission of a requirement that companies pursue approval for the off-label uses they promote “eliminates any incentive for industry to invest in studies beyond those necessary to earn preliminary approval.” The effect of this policy change, they say, could be quite radical. “The FDA might be left out of the regulatory loop for many of the indications for which companies market drugs to physicians.”
Although the American Journal of Bioethics is a subscription based journal, Andy’s time at PLoS naturally made him an open access advocate—so he has retained copyright on the piece (using the Creative Commons Attribution License) and deposited a copy into the freely available eScholarship repository at UC Berkeley.