Patients are, as regulators and industry frequently remind each other, at the heart of every regulatory process and decision. But it can sometimes be difficult to find patients in the regulatory process itself. Now, thanks to a new website just launched by the US Food and Drug Administration (FDA), that paradigm stands to change in a major way.
Power (of Understanding) to the Patients
The new website, FDA's Patient Network, was launched on 23 April 2013, and seems geared toward opening up the regulatory approval process to patients. In an accompanying blog post on the FDA Voice page, FDA Commissioner Margaret Hamburg said the site is intended to "increase patient's interest and participation in the agency's work and in the policies and decisions that affect them."
A large part of that goal seems simply to put regulatory terminology and processes into plain and easy-to-understand terms. Even at first glance, the Patient Network website is a far cry from the cluttered and often difficult-to-navigate labyrinth of webpages that make up www.fda.gov. Instead, visitors are presented with several categories that the agency believes are more in line with what a patient might be interested in: Becoming informed about drug and device regulatory processes, how to get in touch with FDA regulators and attend FDA meetings, how to "take action" by enrolling in clinical trials or checking out new drug approvals, and how to keep in contact with FDA through patient network updates.
Other parts of the website hone in on FDA's apparent intent to involve patients more in the regulatory process. In one page of the website, FDA invites patients to become a "patient representative," which it says will serve on advisory committees, act as a consultant for regulatory review divisions at FDA and be present at FDA's meetings and workshops on regulatory and disease issues.
'New Channels of Communication'
Hamburg said she hopes the website will also serve to open "new channels of communication with the public, such as live chats with senior agency officials"-something that Focus could find no record of the agency having done before. The first chat is already scheduled, in fact, and will take place on 21 May 2013 between patients and FDA's Office of Health and Constituent Affairs.
"We heard you, and we agree," says James Valentine, project manager for the FDA the Patient Network, in a video posted on the agency's website. "Patients should have a bigger voice. The more we interact with each other, the more FDA can help improve peoples' lives."
And that involvement comes at a time when FDA is already reaching out to patients more than ever. Under Section X of the FDA Safety and Innovation Act, the agency has recently launched a new "Patient Focused Drug Development Program" that selected approximately 20 neglected disease areas for a renewed focus on developing regulatory tools to support product development.
"The human drug and biologic review process could benefit from a more systematic and expansive approach to obtaining input from patients who experience a particular disease or condition," FDA noted in a September 2012 Federal Register posting announcing the program.
And if FDA's new website is any indication, that approach is indeed becoming expansive and more systematic.
FDA Patient Network Website
FDA Voice Post
FDA Consumer Update