Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing.
On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information into biotechnology firms’ submissions for approval of medical devices. The Regulatory Affairs Profession Societies website reports:
“US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) have unveiled a proposed framework for the collection and use of patient preference information (PPI) in medical device development.”
Why did the FDA have a change of heart? They begin their draft guidance as follows:
The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients with devices. The Agency understands that patients and caregivers who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights and perspectives on the benefits and risks of devices under PMA, HDE, or de novo review. FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices. This kind of input can be important to consider during regulatory decision-making for certain devices. For this reason, FDA’s guidance document “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”…explains that reviewers may consider certain data measuring patient perspectives during the premarket review process for premarket approval applications (PMAs) and de novo classification requests, when such information is available.
This shift means that device makers will need to be able to reliably collect and quantify patient preferences across products.
2 Comments