by Amanda Conschafter, blog editor
When the American Medical Association gathers this weekend in Dallas, the House of Delegates will consider a resolution with real-world implications for how much – and what sort – of information physicians can access about the medications they prescribe. The resolution centers on information about medications’ off-label uses, for which therapies do not hold an FDA-approved indication but have nevertheless proven effective. With precise and inclusive language, the resolution could redefine restrictions on communications between drug manufacturers and healthcare providers, broadening physicians’ insight about the best therapies for their patients.
Off-label prescribing represents an estimated 10-20 percent of prescriptions, with higher use in fields such as oncology, pediatrics and the treatment of rare diseases. Though the FDA does not regulate off-label prescribing, it does restrict pharmaceutical companies’ communications about their medications’ off-label uses.
In regulating what’s known as “detailing,” the FDA seeks to ensure that physicians’ information about medications remains truthful and evidence-based. But FDA restrictions can have the ironic effect of limiting information from the source with, arguably, the most comprehensive data – the creators of the medications themselves. In addition to details from medications’ development and clinical trials, pharmaceutical companies can shed light on therapies’ real-world effectiveness and success for specific patient sub-populations.
AMA’s resolution addresses these restrictions by establishing criteria for industry-supplied information outside of a medication’s FDA approved labeling. The resolution requires that such information be “truthful” and “non-misleading.” But the AMA also recommends that information include only data that’s “independently derived.” The term leaves for interpretation whether industry-sponsored research, even with the benefit of full disclosure, could contribute to physicians’ knowledge about a therapy.
As detailed in the Institute for Patient Access’ “Informed Prescribing to Further Patient Access” policy brief, physicians’ knowledge about the therapies they prescribe stems from a range of resources: medical journals, research presentations, insurance payers, government, medical societies and pharmaceutical industry. Physicians then must weigh the biases and motivations of each data source. But patients may fare best when their physicians have the benefit of broad, complete information about available therapies.