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FDA Considers Changes in Off-Label Promotion to Doctors

18 Feb 08

The FDA has proposed guidelines that would allow drug makers to distribute reprints of articles from peer-reviewed journals that discuss off-label (i.e., unapproved) uses for medicines.

Global Insight Perspective
Significance	The publication of the proposed guidelines on the FDA's website on Friday (15 February) has sparked a furious debate about the potential for abuse of the relaxed promotion guidelines and the FDA's role in checking information.
Implications	The new guidelines, if approved in their current form, could reduce litigation risks for pharmaceutical companies while also reducing the work load for the FDA.
Outlook	Opposition to the proposed guidelines from certain parts of Congress is expected to be significant. Global Insight expects some formalisation of off-label promotion guidelines; however, it is very unlikely that the FDA will be allowed to get out of its information-review responsibilities so easily.

FDA Issues Controversial Proposal

The U.S. FDA published proposed guidelines on its website on Friday (15 December) that would allow pharma companies to promote drugs for off-label uses to doctors by using reprints of peer-reviewed journal articles. According to the proposal, the FDA would allow use of reprints as long as they are accurate, not misleading and come from peer-reviewed publications. All reprints should also carry a disclaimer saying that they have not been reviewed by the FDA.

Under a law which Congress chose not to renew in 2006, companies were required to submit reprints for FDA review and approval before distributing them to doctors. If the new guidelines are approved, the FDA would no longer have to review reprints before they are presented to doctors. As such the agency would not play a role in verifying the accuracy of information contained in the reprints. The implicit understanding of the agency and industry will be that if the articles were published in the peer-reviewed journals in the first place their accuracy must have been verified by the publication already.

Outlook and Implications

The proposed guidelines are not likely to be approved in their current form, according to Global Insight's estimates. Democratic Representative Henry Waxman of California has already voiced concerns about the proposed guidelines and other Congress members are expected to follow suit. There are several reasons for this. First off, fresh from approving a substantial budget increase for the FDA under PDUFA IV, Congress will not want to see the agency's responsibilities and workload diminished. Secondly, had the Democrat-dominated Congress wanted to see off-label promotion of drugs to doctors allowed, it would have renewed the 2006 law.

There is also a lot at stake. Drugs used off-label accounted for 21% of drug use overall, according to a 2006 report in the Archives of Internal Medicine. The proportion is higher in some therapeutic groups. For example, as much as 46% of cardiac therapy prescriptions and 31% of psychiatric prescriptions were for off-label uses, according to the same study. Prescription drugs used off-label are not eligible for reimbursement, with rare exceptions, and the product liability litigation risks for manufacturers are higher.

The practice at the moment is that, in the absence of a law, some pharma companies continue to provide marketing materials promoting the off-label use of drugs to doctors. They do so at their own risk. The Justice Department can go after them—and has done so recently—with the result being hefty settlements over off-label promotion. The FDA's proposed guidelines could provide a defence to such companies in future, both in product liability cases and Justice Department prosecutions. On the other hand, introducing some requirements—such as the use of reprints from peer-reviewed journals only—could bring some regulation to the sector and deter certain companies from engaging in more aggressive off-label promotion practices for prescription drugs.

However, there is another side to the coin—and this is the side that Congress is more likely to see. There have been reports in recent months suggesting that peer-reviewed journals are more likely to publish positive results than negative ones (see United States: 17 January 2008: Unpublished Studies Revelation Casts Doubt over Antidepressants' Efficacy). This finding would suggest that peer-reviewed journals cannot necessarily be expected to police the accuracy of clinical data and that this role is better left to the FDA—especially with regard to the promotion of off-label use of prescription drugs. All this considered, although there is a need for new guidelines the FDA is unlikely to be allowed to pass on its information review responsibilities to others quite so easily.

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