Slammed by Patients, CDRH Launches Patient Input Effort
[Analysis by Jim Dickinson] Billed in a news release as a “pioneering event,” FDA recently held the first meeting of its CDRH-created Patient Engagement Advisory Committee (PEAC), an event which commissioner Scott Gottlieb hailed as “a significant step forward in the FDA’s efforts to broaden its engagement with patients and to deepen the involvement of patients in our regulatory activities.” It’s the first advisory committee composed “solely of patients, caregivers, and those who represent their needs,” Gottlieb said.
Authorized by Sec. 1137 of the FDA Safety and Innovation Act in 2012, the PEAC as described in Gottlieb’s statement was founded by CDRH three years later as part of its “commitment to keep patients at the center of their work” notwithstanding recent patient-centered angst over that Center’s performance in a number of controversies over injuries and deaths from medical devices they allege should never have been approved. One such injured patient, former CDRH advisory committee consumer representative Paula Cofer, called the announcement “a joke because the FDA has refused to act on virtually all of our concerns over the years about LASIK.”
CDRH has had a troubled history with several of its patient constituencies, stirring angry complaints from patients claiming serious injuries from a raft of regulated devices, including the Essure permanent birth control coil, power morcellators, dental amalgam and LASIK devices for vision correction.
The broadly sourced criticisms became so volatile last year that a petition to fire CDRH director Jeffrey Shuren drew hundreds of signatures, the first such action against any FDA leader (it got nowhere, signifying a characteristic lack of patient empowerment that Gottlieb’s new initiative may coincidentally help to overcome).
In a recent lawsuit against a LASIK ophthalmologist, the injured plaintiff was stymied by an inability to demonstrate that the defendant knew or should have known about the LASIK procedure’s hazards, as proved by post-surgical patient experiences. CDRH possessed much of that information but did not share it with the ophthalmology community in the form of a public safety alert. CDRH’s policy has been to defend its original decisions in approving the LASIK devices, thus obstructing patients’ complaints and this lawsuit.
Perhaps obliquely signaling a recent top-level reorientation of CDRH’s approach, Gottlieb’s announcement gave much credit to the Center for “working with a diverse group of outside partners to encourage the inclusion of patient perspectives across the total medical device life cycle, from the design and ideation of the medical device to the clinical trial process and through the postmarket evaluation.” FDA spokesperson Stephanie Coccomo told us it’s too early to speculate on the CDRH’s initiative spreading to other Centers, “we believe the first meeting was very successful and is worthy of modeling.”
CDER director Janet Woodcock is enthusiastic about the value patient engagement has brought to her Center through the 20 Voice of the Patient multimedia meetings it has had so far on specific diseases since the first one in 2013. The series sprang from a commitment the agency made under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) that aims to more systematically gather patients’ perspectives on their condition and available therapies to treat their condition. Woodcock told us the meetings “have been very successful and had an impact on the regulators at least!”
For example, in its report of a meeting with psoriasis patients and caregivers last year, the agency said it “is grateful to the patients and caregivers who so thoughtfully, generously, and indeed courageously shared their personal stories of living with psoriasis. Through this meeting, FDA learned more about what matters most to patients and caregivers regarding symptoms, impacts, and aspects of psoriasis treatments. The participants’ sense of community and their desire to advocate for current and future generations at risk for psoriasis were strikingly clear. FDA shares the patient community’s desire and commitment to furthering the development of new safe and effective drug therapies to treat psoriasis.”
Regulated industry has long recognized the value of patient input in the development of new drugs and devices, such as this one, a collaboration involving an implantable artificial kidney by Home Dialyzors United, Vanderbilt University and University of California San Francisco.
Like other FDA initiatives over the years, this one could end up gathering dust on a shelf, despite Woodcock’s enthusiasm.
And as health writer Bob Roehr observes after years reporting on similar efforts, such meetings/initiatives can potentially be useful, but they can also end up being window dressing. None of them, he says, “commit money to educating and training members of the public and patients to participate in the research and regulatory processes, be it truly informed consent, participation in local IRBs, or serving on advisory committees such as those at the NIH and FDA, including those that review drug applications. HHS spends huge amounts of money to educate and train scientists and clinicians, and to get them to fill out the proper compliance forms, etc. But to the best of my knowledge, there has been no budgetary line item devoted to improving the capacity of the public/patients to participate in these activities as equal partners rather than as subjects who are acted upon.”
FDA’S Caccomo calls that a mischaracterization of the CDRH initiative’s purpose: “The PEAC is a forum for the voice of patients. It will be asked to advise on complex issues related to medical devices and their impact on patients. The goal of PEAC is to better understand and integrate patient perspectives into our oversight, to improve communications with patients about benefits, risks, and clinical outcomes related to medical devices, and to identify new approaches, unforeseen risks or barriers, and unintended consequences from the use of medical devices.” She added that FDA did “conduct training for the committee members before this PEAC meeting which included material on regulatory as well as clinical trials processes. We will continue to provide topic-related training at all subsequent PEAC meetings.”
Asked to provide the PEAC’s budget, Caccomo replied that is not releasable without submission of a Freedom of Information Act request, something that can take months to fulfill.
The nine members of the new advisory committee are:
Paul Conway (chair) – president of the American Association of Kidney Patients.
Katherine Seelman, PhD – (consumer representative) – retired from the University of Pittsburgh as Professor Emerita in 2016.
Cynthia Chauhan, MSW – served as a patient advocate for over 17 years. Served as an FDA patient representative for the National Mammography Quality Assurance Advisory Committee.
Amye Leong, MBA – president and CEO of Health Motivations. Extensive patient advocacy history, communications specialist, health policy advisor, author.
Monica Willis-Parker, MD – director, Minority Engagement Core, Emory Alzheimer’s Disease Research Center.
Frederick Downs, Jr., MBA – decorated Vietnam veteran, who retired from the Veterans Administration as the senior executive service chief procurement and logistics officer.
Bennet Dunlap, MS – health communicator and advocate for people with diabetes, with experience in social media and marketing programs.
Deborah Cornwall, MBA – patient advocacy expert. She is a longtime leadership volunteer for the American Cancer Society and the Cancer Action Network.
Suzanne Schrandt, JD – director of patient engagement at the Arthritis Foundation.