Abstract
BACKGROUND: After a new drug or medical device is approved by the US Food and Drug Administration (FDA), physician-patient communication about benefits and risks is critical, including whether the product was approved through an expedited pathway based on limited evidence. In addition, physician reporting of drug- and device-related adverse events in real-world use is necessary to have a complete safety profile. We studied physician-reported communication and safety-reporting practices related to drugs and devices. METHODS: We surveyed a random national sample of American Board of Internal Medicine-certified internists, cardiologists, and oncologists between October 2021 and September 2022 about the sources of information used to prescribe a drug or medical device, details of communication with patients, and reporting of adverse events. RESULTS: Among 509 respondents (39% response rate), 387 (76%) reported that FDA approval influenced their decision "a lot" to prescribe a new drug or recommend use of a medical device. Half (122; 50%) of the 244 physicians randomized to receive a question about their own communication of trial endpoints reported "usually" telling patients when products were approved based on surrogate measures and 126 (52%) "usually" reported telling patients if a postapproval trial was required to evaluate safety and effectiveness. Two-thirds (165) said they were likely to report drug- or device-related adverse events to FDA. CONCLUSIONS: Physician self-reporting of communication with patients about drugs and devices suggests that half include characteristics of the pivotal trials such as use of clinically meaningful endpoints or continued requirement for evidence generation. IMPLICATIONS: More consistent discussions with patients about the quality of evidence supporting new drugs and devices and increased reporting of adverse events could ensure optimal use of these products in clinical practice. HIGHLIGHTS: Among 509 board-certified internists, cardiologists, and oncologists, half reported telling patients when drugs or medical devices were approved based on surrogate measures and when there was an FDA-mandated postapproval trial to further evaluate safety and effectiveness.As drugs and medical devices are increasingly approved by the FDA through expedited pathways based on data with lingering uncertainties, discussion with patients about issues such as the nature of the endpoints assessed and existence of postapproval testing requirements can help inform patient decision making.