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Sept. 22 — A new patient committee will advise the FDA on medical device issues, the agency announced.
The Food and Drug Administration's Patient Engagement Advisory Committee will provide advice to the commissioner on a range of complex issues relating to medical devices, the regulation of devices and their use by patients, an agency blog said Sept. 18.
The panel will meet to discuss topics such as agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, patient reported outcomes and device-related quality of life or health status issues, a Sept. 21 Federal Register notice (80 Fed. Reg. 57,007; FDA-2015-N-3166) said.
Comments on the notice announcing the panel's creation, and suggestions on potential committee meeting topics, are due Nov. 20.
The committee's creation drew mixed reaction from patient, consumer and device industry trade groups.
Marc Boutin, the chief executive officer of the National Health Council, a patient advocacy group for people with chronic conditions, told Bloomberg BNA Sept. 22 that the group welcomed the committee's creation.
The panel is “a huge step in the right direction,” Boutin said. The council has been advocating the FDA to create such a panel for nine years, according to Boutin.
Currently, device development is focused on the clinical outcome, Boutin told Bloomberg BNA. He said the medical field is one of the few areas where manufacturers don’t gather information on what's important to the end user before starting to design a treatment product. “We only now get patient preference information at the end of the development cycle, and sometimes even after the product is approved,” Boutin said.
With the panel, Boutin said, patients will be able to communicate directly with the FDA about what they want out of the devices they use.
Janet Trunzo, the senior executive vice president for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed), a device industry group, said in a Sept. 22 statement provided to Bloomberg BNA that it is still reviewing the specifics of the FDA’s committee proposal. However, she added, “AdvaMed supports the agency’s efforts to encourage greater participation from the patient community in the development and availability of medical technology. We will be submitting comments on the potential topics to be addressed by this new panel by the designated deadline.”
However, Public Citizen, a consumer advocacy organization, offered a cautious appraisal of the panel.
“Public Citizen doesn’t oppose the idea of more patient engagement, as a general principal,” Sarah Sorscher, an attorney with the organization's health research group, said in a Sept. 22 e-mail. “Unfortunately, too often efforts that are characterized as ‘patient-centered' are in fact funded and guided by drug and device manufacturers.”
Sorscher told Bloomberg BNA that the concept of patient choice is also sometimes used as a tool “to pressure the FDA to abandon its role as gatekeeper and let the market decide whether a drug or device is used.” Such pressure exposes patients to misinformation and risk from poorly-tested products and it “remains to be seen whether the patient engagement advisory committee will have these problems,” she said.
Similarly, Diana Zuckerman, the president of the National Center for Health Research, a nonprofit group that encourages new and more effective programs and medical treatments, told Bloomberg BNA Sept. 22 that while the FDA needs to do a better job of including patients’ perspectives, segregating patients into their own committee “is probably not the best way to do that.”
According to the blog post, the committee will give the FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process.
Nina Hunter, a regulatory scientist in the FDA's Center for Devices and Radiological Health (CDRH), and Robert Califf, the agency's deputy commissioner for medical products and tobacco, authored the blog post. President Barack Obama nominated Califf to be the agency's commissioner Sept. 15. Stephen Ostroff is currently the FDA's acting commissioner.
Some questions that the panel may discuss include where and how best to engage patients across the device development and assessment life cycle as well as how the FDA and sponsors should communicate patient preference information to patients, the blog said.
In addition, the FDA's blog said, the panel complements other agency efforts to bring the patient into the medical device regulatory process. For example, the FDA recently published draft guidance on how outside parties should submit patient preference information to the agency's device regulators.
That draft guidance drew criticism from Public Citizen, which called for it to be withdrawn. However, AdvaMed generally welcomed the document in its comments. Comments on the draft guidance were due Aug. 17.
In three separate but related Federal Register notices, the FDA requested nominations for members of the Patient Engagement Advisory Committee from the general public (80 Fed. Reg. 57,003; FDA-2015-N-3224), consumer groups (80 Fed. Reg. 57,002; FDA-2015-N-3224) and device industry groups (80 Fed. Reg. 57,004; FDA-2015-N-3173).
The committee will consist “of a core of nine voting members, including the chair,” the notice on the panel's creation said. Committee members will be selected by the FDA commissioner or his or her designee, the same notice said.
Furthermore, the notice said, one spot on the full committee will be reserved for a voting representative of a consumer organization. The commissioner will also have the authority to select from a group of individuals nominated by device industry groups to serve as temporary nonvoting members of the committee, the notice said. The number of temporary nonvoting members selected for a particular meeting will depend on the meeting topic, according to the notice.
Consumer groups interested in nominating a voting consumer representative and industry groups interested in nominating nonvoting committee members must inform the FDA of their interest by Oct. 21. Nominations from consumer and industry groups are also due Oct. 21.
Nominations for the other voting committee members are due Nov. 20.
To contact the reporter on this story: Michael D. Williamson in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at email@example.com
The blog post on the committee is at http://blogs.fda.gov/fdavoice/index.php/2015/09/fda-announces-first-ever-patient-engagement-advisory-committee/.
The notice announcing the committee's creation is at http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23521.pdf.
The notice seeking general nominations is at http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23524.pdf.
The notice seeking nominations for a consumer representative from consumer groups is at http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23523.pdf.
The notice seeking nominations from industry groups is at http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23522.pdf.
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