Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 08 August 2013 | By Alexander Gaffney, RAC,
The latest trend at the US Food and Drug Administration (FDA) seems to be involving patients in as many of the agency's decision- and policy-making processes as possible. From drugs to devices and specific regulation to general consultation, patients seem to be raising their voices in more and more settings that used to be the general purview of regulators and industry. But with that involvement has come a need to explain to patients exactly how that process works, a need FDA has been trying to fill in a variety of ways.
FDA's efforts with respect to patient involvement have been ongoing since the early 1990s, when AIDS patient advocacy groups demanded a proverbial "seat at the table" from which to represent the views and needs of desperate patients.
From then, patients eventually became a staple of FDA's advisory committee meetings, generally filling at least one seat on the committee itself and regularly making presentations either for or against a product or policy.
But since 2012, patient involvement has been slated to increase in ways never before seen at FDA. Most notable was the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA). Section X of the act directed FDA to set up a "Patient-Focused Drug Development Initiative." That initiative is intended to seek out the opinions of patients afflicted with 20 different types of serious diseases for which there are no or few treatment options.
The key differentiator of the initiative: Instead of FDA formulating what meaningful endpoints of treatment should or would be beneficial to patients, the agency is directly asking those patients what they think and what is most meaningful to them.
FDA has already held four of the patient-centered drug development meetings, focused on HIV, lung cancer, narcolepsy and chronic fatigue syndrome.
In addition, the agency recently announced that it wants to involve patients in the medical device regulatory process, writing in a Federal Register notice that a "Patient Preference Initiative" has been launched within the agency and will be introduced to the public at a two-day September 2013 meeting.
But with patient involvement slated to increase, the agency has discovered a common problem: Patients don't understand FDA's regulatory processes well enough to provide adequate insight.
To combat this, in April 2013 FDA launched its Patient Network, a patient-specific website that it said was 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.
In a subsequent interview with James Valentine, then program analyst at FDA and one of the FDA staff who worked on the project, Valentine told Focus that FDA's main goal was "to provide a resource for any patient or patient advocate that is at all interested in FDA-regulated medical products or issues to have a home for getting educated about these products, how they're regulated and how they can be a part of that regulatory process."
"We know that some patients will only come to the site to get some information, but we hope that other patients will actually become advocates for their patient community and that it will allow them to provide FDA with their unique patient perspective, allowing us to make better-informed decisions with that perspective," Valentine continued. "We really wanted to centralize what was otherwise disparate information that is important to patients and patient advocates in a central location and make that information usable and also written in such a way that the patient audience could comprehend it."
"We figured that they are the best people to tell us what they need from FDA," he added.
And in addition to web-based education, FDA has also started to hold meetings. In May 2013, for example, FDA held its first Patient Network program meeting, entitled "Input into FDA Benefit-Risk decision-making: Opportunities and Challenges." The agency said it hoped the meeting would allow patients to "learn more about the regulatory process related to the medical product life cycle, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to collecting and incorporating meaningful input that well represents broad patient perspectives into regulatory decisions."
Now the agency has announced another similar meeting.
In an 8 August 2013 Federal Register notice, the agency announced it will hold a second "annual meeting" of the Patient Network entitled, "Demystifying Food and Drug Administration: An Exploration of Drug Development Hosted by the Food and Drug Administration Office of Health and Constituent Affairs."
As with the first meeting, FDA said it plans to educate attendees on regulatory topics, and specifically "provide a primer on drug product development and explore patient involvement in drug development."
"The meeting will serve as a forum for FDA's patient stakeholders and the general public […] to learn about FDA's role in, and various regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in drug development and regulatory decision making," FDA explains in the notice. "We believe that enhancing patients' understanding of the drug development process will provide a better foundation for their participation in regulatory decision making, and clarify where patient input can be most meaningful in the drug development life cycle," the agency added.
The meeting is "intended to build upon the objectives of the inaugural Patient Network Annual Meeting" that was held in May 2013, FDA wrote.
The upcoming meeting will be held on 10 September 2013 at the Washington Marriott in Washington, DC. It will also be available online via an FDA webcast.
Patient Network Meeting Announcement
Regulatory Focus newsletters
All the biggest regulatory news and happenings.