Industry, the U.S. Food and Drug Administration (FDA), and patient groups agree that patient-reported outcomes (PROs) should be included in labeling for oncology products, but there is not consensus on how to do so.
The various stakeholders met in a panel discussion last year at the plenary session of the annual Accelerating Anticancer Agent Development and Validation Workshop in Bethesda, MD, where frustrations were aired and frank views were exchanged. A report of their discussion was published recently in JAMA Oncology.1
PRO-based claims are now included in the labeling of as many as 25% of new drug products in the United States, but only 1 of 43 oncology products approved by the FDA between 2006 and 2013 carry such claims.
The biggest stumbling block is the development of measurement instruments that meet FDA standards. The panel reported that “a cycle of negative feedback exists, in which the FDA asserts that industry puts little effort into developing rigorous PRO end points and industry asserts that it is not worth the effort because the FDA’s bar is too high.”
Industry Finds FDA Too Strict
Industry representatives on the panel said that it is too difficult to develop disease-specific measures of PROs that will find favor with the FDA, particularly when so many oncology products undergo accelerated review and are tested in relatively small numbers of patients.
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Industry also complained about inconsistency in implementation of PRO data among different divisions of the FDA and extended evidence reviews, which delay the development of new products.
In the end, industry representatives threw the ball back to the regulators’ court, saying it is up to the FDA to motivate pharmaceutical companies to measure and report PROs.