Waxman To FDA: Watch Those Journal Articles

The chairman of the House Oversight and Government Reform committee is concerned that a new FDA draft guidance about distributing journal articles will open the door to promote “potentially dangerous uses” of drugs and devices without prior FDA review and approval. The forthcoming guidance, which you can see here, represents FDA thinking on the publication and dissemination of studies on unapproved new uses of approved drugs and devices.

The topic gained attention several years ago as a commercial free speech issue, and in the guidance, the FDA writes that “the public health may be advanced by healthcare professional’s receipt of medical journal articles and medical or scientific reference publications on unapproved or new uses of approved or cleared medical products that are truthful and not misleading…If a manufacturer follows the recommendations found in…the guidance and there is no unlawful promotion of the product, the FDA does not intend to use the distribution of medical and scientific information as evidence of an intent by the manufacturer that the product be used for an unapproved use.”

But Waxman is concerned the agency is opening what he calls an “ill-advised guidance” and a big loophole for drug and device makers. The plan would allow companies to “short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he writes in a letter to FDA commish Andy von Eschenbach. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices, and puts the public at risk for ineffective and dangerous uses of drugs.”

The draft guidance, in Waxman’s view, would allow companies to distribute articles on unapproved uses as long as they are published in peer-reviewed journals (not including supplements paid for by a manufacturer); not false or misleading; not abridged or summarized by the manufacturer; accompanied by approved labeling for product;distributed separately from promotional materials; and accompanied by a number of disclaimers and disclosures.

“The draft guidance poses multiple risks. First, it appears to be based on the premise that peer-reviewed reports provide accurate, validated information and that even if individual articles are biased, the published literature as a whole can provide balance. Regrettably, recent experience shows that this is not always the case,” Waxman writes. “Whistleblower lawsuit settlements reveal that the use of publications to promote off-label uses is a concerted strategy>Published studies of SSRIs in children were also distorted to make their products appear better than they are.”

“Second, the draft guidance may create a disincentive’for drug and device manufacturers to seek approval for unapproved uses. It is certainly more profitable to be able to promote a use without undergoing rigorous FDA review, but it will be at the cost of exposing patients to more unsafe and ineffective uses of medicines and devices,” he continues. “The new guidance would allow companies to sidestep the FDA review process, and could transform the stream of high-profile problems listed in the addendum into a torrent.”

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