As we are in an era of “patient-centered” medical care, the focus of health care now enables patients to make choices regarding their physicians, hospitals, and treatment options. The transparency of medical costs allow patients to “shop-around” for their healthcare preferences, and gone are the days of simply letting health care providers guide medical decisions. In a recent article on the FDA’s website, they have fostered this idea and announced their first ever Patient Engagement Advisory Committee (PEAC). This committee is part of the FDA’s Patient Preference Initiative, which was launched in 2013, and marks an additional way to incorporate patients’ views on benefits and risks with those of the FDA’s scientists, engineers, and medical professionals. The PEAC will provide the FDA with advice on patient-related topics relating to medical devices, their use in patients, and the regulation of these devices. The FDA hopes to integrate patient perspectives into the regulatory process, specifically as these relate to patients’ tolerance for risks and their perspectives on benefits. The PEAC plans to accomplish this by “discussing and providing advice and recommendation in ways such as: Identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy”.
Through studies to evaluate patient preferences in medical devices, the FDA can ensure the safety and effectiveness of medical devices based off of scientific evidence, and gauge consumer input as well. The goal is to utilize clinical and nonclinical testing to help better identify the most meaningful benefits or unreasonable risks of these research therapies. This data is to be to be incorporated into the FDA’s assessment of the benefit-risk profile of certain devices.
Title 21 Part 812.30 in the Code of Regulations speaks to the risks to subjects and if they are not outweighed by the anticipated benefits, then approval of the device will not occur. This raises an interesting point on the impact of scientific-based evidence of risks and benefits versus the popular opinion gained from the PEAC. While consumer insight may provide the FDA with more information, it poses the question of how will these opinions be weighed against the factual results from research studies. How much should public opinion influence the benefit-risk analysis and potential approval of devices?
The FDA has indicated that when the data meets the requisite standards, the FDA device reviewers may consider patient preference data in the overall evaluation of certain devices. In those instances where the device is approved, device labeling could include a description of the range of patient preferences reflecting the data collected. This additional data provided to patients and healthcare practitioners may enable them to make better informed decisions, and thus propagate the evolution of “patient-centered” medical care.
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