Maurie Markman, MD
Controversy over the FDA’s role in regulating off-label marketing practices of pharmaceutical companies continues to reverberate in the medical community. In a recent editorial, leading bioethicists cited a 2012 US Court of Appeals ruling that struck down the FDA’s ability to control the speech of a pharmaceutical company representative as long as the language was “truthful and nonmisleading.”1
Although there certainly should be restraints on inaccurate or inappropriate promotion of medications, the question of whether pharmaceutical representatives should be required to adhere to the approved product label when discussing the use of antineoplastic agents is much more complex and nuanced. Is it truly in the public’s interest for a pharmaceutical company representative to be barred from discussing with physicians data from peer-reviewed literature that may help clinicians improve the administration of a drug?
Experience Contradicts Label
Consider, for example, the experience of the oncology community with pegylated liposomal doxorubicin in the management of recurrent and platinum-resistant ovarian cancer.2 The FDA approved this drug for this clinical indication based on data from an initial phase II trial and a subsequently conducted randomized phase III trial. In these studies, the initial drug dose delivered and approved was 50 mg/m2
every 28 days.
Instead of protecting the public, rules that deny pharmaceutical company representatives the ability to provide information that might improve the management of care for a patient with cancer because the material is not contained in the label represents a failure to promote public health through an open discussion of the benefits and risks of medical products.
Labels May Be Too Narrow
Another illustration of the sometimes strikingly narrow clinical indications for oncology drugs and the impact on a meaningful dialogue between representatives of the pharmaceutical industry and practicing clinicians concerns the initial regulatory approval of several PARP inhibitors for patients with previously treated epithelial ovarian cancer. Two novel agents, olaparib and rucaparib, gained regulatory approval for commercial sale based on phase II trial data demonstrating high objective response rates with relatively long times to subsequent disease progression.3
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