FDA is proposing a new template for all product recalls, from medical devices to pet food, that seeks to have firms put recalls into the proper context. It also offers them some flexibility in wording the announcements made in response to safety reports.
The agency's Office of Regulatory Affairs presented FDA's Risk Communication Advisory Committee with a model of the proposed template, which the agency has been developing for several months.
An internal working group will take the committee's suggestions into consideration as it finalizes the form, said David Elder, director of ORA's Office of Enforcement, at the inaugural committee meeting, held Feb. 28-29 in Gaithersburg, Md.
FDA sought advice from the committee on the structure and content of the template, whether it will actually reduce risks to patients and whether standardization is appropriate across all FDA products.
"I heard a lot of support for the basic approach, for standardization," said committee chair Baruch Fischhoff, Ph.D., Carnegie Mellon University, "with a recognition that one size probably won't fit all."
While the risk communication experts liked ORA's draft template overall, many agreed that consumer alerts involving medical devices, particularly implanted products, pose a unique challenge.
New Template Offers Some Flexibility For Industry
Essentially, the new template would structure the way FDA presents information about product issues, in hopes of getting the message through to consumers and health care providers. "One of the goals of the proposal was to reverse the procedure of a one or two or three page narrative and put the information in a more useful way," Elder said.
He says the template will allow the agency to get information out faster.
The proposed template includes subsections for detailing the problem, who is at risk, how to identify the product, where it is distributed, what the symptoms are and who should be contacted.
For the purposes of the release, the action can be dubbed a recall, correction or market withdrawal.
The Heart Rhythm Society applauded FDA's efforts to create a precise and effective recall template, but noted, "This hasn't been done yet."
HRS recommends that FDA eliminate the term "recall" from all public communications about implantable cardiac devices and other implanted products. It says FDA should change "class I recall" to class I "advisory notice" or "safety alert," and change class II and III recalls for non life-threatening malfunctions or potential malfunctions to "safety notices" (1"The Gray Sheet" Oct. 2, 2006, p. 3).
HRS is concerned that the term "recall" confuses patients about whether or not they should have their device explanted.
Panel consultant Michael Wogalter, a psychology professor at North Carolina State University, shared his research on the topic with the panel. Wogalter found that people prefer to see the word recall for everything except for medically implanted devices.
"We're well aware that there is some information on implantable products that may need to be handled differently," responded Michael Verdi, senior recall coordinator at CDRH.
But he maintains the word recall is needed to alert patients and doctors to the situation. More nuanced product information can follow in the body of the document, Verdi adds.
FDA also says the press release should include useful information to put the risk into perspective. For example, the proposed template says, ICD or pacemaker notices could include: "This is a life-saving device. Malfunctions and failures are rare. Even if the device fails to work properly, it usually will not harm the patient."
"Certainly we don't want the risk downplayed," said Elder, "but we want to characterize it." He said his office is still seeking advice from industry on the template. "Step one is please advise us how we can do this, whether we're on the right track."
