Guest Editorial

Off-label use: Honesty is the only policy

By Mark Packer, MD, FACS, CPI

Off-label use, i.e., the prescription of FDA-approved drugs and devices in a manner not specified in the labeling directions, is the basis of many accepted practices, including some that are standard of care. These include prescribing a topical antibiotic as prophylaxis for endophthalmitis after cataract surgery or using one as an intracameral injection. The decision to use an approved drug or device off-label lies within the purview of the practice of medicine, and “a physician may help avoid professional liability when prescribing approved drugs for off-label uses if he or she puts the patient’s interests first and can point to sound scientific and clinical data that support the off-label use in question.”¹

But the FDA has held manufacturers to a different standard regarding off-label promotion. The agency states in its Guidance for Industry, Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices, “Under the FD&C Act, an approved new drug that is accompanied by ... printed, or graphic matter that suggests an unapproved use may be an unapproved new drug with respect to that use. Furthermore, an approved prescription drug ... intended for an unapproved use [whether referenced in labeling or not] would be considered misbranded ... the drug does not meet the regulatory exemptions from the requirement that its labeling bear ‘adequate directions for use.’ ... a medical device ... intended for an unapproved use is considered adulterated and misbranded.”²

However, judicial trends indicate that change is afoot, based on First Amendment protection of speech. As reported by Jeffrey K. Shapiro, JD, Hyman, Phelps & McNamara in Washington, D.C., “The Department of Justice’s recent criminal prosecution of Vascular Solutions Inc. [VSI] ended in a spectacular loss for the government. ... the jury unanimously acquitted VSI and its chief executive officer of ... misbranding products due to ‘off-label’ promotion.”³ Of note, the judge’s directions to the jury specified doctors may use medical devices approved “for one use for a different use that has not been cleared or approved by the FDA.” This is not illegal, it is not a crime for a device company “to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”⁴ A blog on the Hyman website notes, “This … is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act.”⁵

Representatives of the medical industry often are important sources of new information for physicians; the First Amendment protects their engaging in “solely truthful and not misleading” speech. When new scientific data become available that are relevant to off-label use, I expect industry reps to be familiar with them.⁶ Open dialogue between clinicians and industry paves the path of progress. OM

REFERENCES

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	Dr. Packer is president of Mark Packer MD Consulting. Financial disclosures: Dr. Packer is a consultant to Alcon (Novartis AG), Bausch & Lomb (Valeant Pharmaceuticals International), International Biomedical Devices and Lensar (Alphaeon).