Testing and approving new drugs and medical devices calls for companies to meet set benchmarks established by the regulatory body’s process, but this process can lack a human element. The Food and Drug Administration is trying to overcome that shortcoming with a new committee that will try to understand what patients need and want, and provide feedback to the agency. This Patient Engagement Advisory Committee aims to give patients a voice in the new diagnostics and treatments that are being developed for them.
Patients have always had a say in the care that they receive, but the way medical decisions are made is changing. Physicians no longer have a monopoly on healthcare information. Patients come to their medical appointments armed with their own research, gleaned from Internet searches. That’s leading physicians to change how they interact with their patients. Medicine is evolving into a more patient-centered model in which patients are active participants in all of the decisions and priority setting related to their health, the FDA explains in a blog post.
“The FDA believes that patients can and should bring their own experiences to bear in helping the Agency define meaningful benefits or unreasonable risks for certain new devices,” the agency said.
This patient engagement committee will give the FDA advice and feedback about medical devices, the regulation of these products, and their use by patients. The FDA says that the overall goal is to improve communication about the risks and the benefits of making patient perspectives a bigger part of the regulatory process. The FDA will still use clinical trial data to make its decisions about approving new drugs and device, but patient information will become part of the overall evidence that is part of the decision. They does caution, however, that if the FDA determines that a device poses an “unreasonable or significant risk of illness or injury,” the agency would not approve that device.
The exact nature of this new committee’s interaction with regulators still needs to be worked out, but it’s been a long time coming. The patient voice is a needed one in regulatory matters and the patient engagement committee is a step that helps ensure that this voice is heard.
To learn more about how your company can create a patient-centric approach, join us at Digital Pharma East, taking place October 24-27, 2016 in Philadelphia, PA. This year’s event brings together more than 800 pharmaceutical, biotech and medical device innovators who are implementing company-wide digital ecosystems to embed digital health across all channels to enhance customer experience. To learn more about this event please download the brochure or visit the website. Click here to register and be sure to mention Priority Code C649BLOG.