The US Food and Drug Administration (FDA) walks a tightrope trying to keep Americans safe from harmful medications and dangerous medical devices while also trying to provide them with new, life-saving, and cost cutting treatment options. Many consumers criticize the administration for not doing enough to protect consumers, while others claim the agency is stifling advances in medicine.
The FDA has recently taken pivotal steps in addressing criticisms by drafting policies about conflicts of interest within the administration and it is looking for comments. The drafted policies outline when it’s acceptable for the administration to receive gifts, but more importantly, they also discuss how the FDA will evaluate conflicts of interest in advisory committee members. If the FDA finds an advisory committee member has a conflict of interest, they will be banned from voting.
In addition to addressing the pre-approval process, FDA Commissioner Robert Califf released an opinion article calling for a national evaluation system for medical devices. Califf said the system would “enable the FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations.”
Califf suggests building upon existing efforts from professional societies and agencies to help create a new system in hopes the FDA can establish a much more “efficient system that rewards innovation that leads to better health outcomes…that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.”
Under the current system, physicians are not required to report adverse events from medical devices, and this makes it difficult and usually time consuming to spot potentially defective devices. This was the case with the power morcellator used in laparoscopic hysterectomies. The device was used in thousands of surgeries before it was widely known to greatly increase the chance of spreading cancer throughout the body.
While the draft policies and statements from the FDA Commissioner boldly call for change, it will likely be some time before implementation of any policies can take place. However, these are encouraging first steps for critics.