BETHESDA, MD 13 January 2014—The most frequently used communication tool in risk evaluation and mitigation strategy (REMS) programs for pharmaceuticals apparently reaches a "relatively low" percentage of the intended recipients, an FDA analyst reported on December 17.
According to Julia Ju, a social scientist at FDA, as few as 13% of recipients of a "Dear Healthcare Professional" letter concerning a REMS can recall receiving the material. The median is 28%, with a recall rate of 82% at the high end of the range. Of the intended recipients who recall receiving such a letter, Ju said, about 72% report reading all or most of it.
These overall results came from company-sponsored surveys conducted as part of 16 REMS program assessments that FDA reviewed from October 1, 2012, to September 30, 2013, Ju told members of FDA’s Risk Communication Advisory Committee. Fourteen other program assessments did not have information about receipt of the "Dear Healthcare Professional" letter that was part of the REMS.
In general, Ju said, the response rate to each program-specific survey was 5–10%, a range she called typical for this type of uncompensated work.
As for the recall rate for receipt of a letter, "I think that is really human behavior," she said.
"Then that," retorted committee member Roxane Cohen Silver, a professor of psychology and social behavior at the University of California, Irvine, "is really not the ideal way to communicate."
Peter J. Kaboli, an internist who is a member of FDA’s Drug Safety and Risk Management Advisory Committee and was at the communication committee’s December 17 meeting as a consultant, asked whether FDA can eliminate paper letters in favor of e-mails for companies’ REMS-related communications.
Kaboli practices internal medicine at the Veterans Affairs medical center in Iowa City, Iowa.
He hinted that unsolicited incoming mail at his office tends to go quickly to the recycling bin.
FDA personnel at the meeting admitted that the agency does not know who actually opens the REMS-related letters addressed to health care professionals.
Nananda Col, a physician who specializes in risk modeling and decision support, asked whether companies could alter the envelope holding a "Dear Healthcare Professional" letter. The addition of a logo indicating that FDA supports the content of the enclosed letter perhaps could get more of the intended recipients to pay attention, she suggested.
To do that, FDA personnel responded, the agency would have to revise a regulation.
The regulation dates from 1975 and specifies the language manufacturers may print on an envelope and even the typeface and color of the statement "IMPORTANT DRUG WARNING."
But acting chair William K. Hallman, whose expertise is social psychology, urged FDA to think "way, way out of the box."
Hallman, a professor at Rutgers, the State University of New Jersey, in New Brunswick, asked whether FDA has the authority to require a REMS logo on all material sent to prescribers about drugs with a REMS program. The special logo would serve as a cue to prescribers, he said.
Sending letters to health care providers is not the only way for a pharmaceutical company to conduct REMS-required communication with those professionals.
The Food and Drug Administration Amendments Act of 2007 mentions as possible components of a communication plan "sending letters" and also "disseminating information." Regarding the latter, information could be disseminated about the elements of the REMS to encourage implementation by health care providers; or information could be disseminated to health care providers through professional societies about any serious risk of the medication and any protocol to ensure the medication’s safe use.
There are no federal regulations providing further details of a REMS-required communication plan.
But FDA in 2009 issued draft guidance regarding the format and content of companies’ proposals of REMS programs.
The draft guidance’s example of a communication plan mentions sending letters by mass mailing and posting copies of that material at the product’s REMS program website.
Of the 30 REMS program assessments that FDA reviewed from October 2012 through September 2013, 29 had a REMS-dedicated website, Ju reported.
She did not report the extent to which health care providers accessed those websites.
Marketing professor Parthasarathy Krishnamurthy, from the University of Houston, suggested FDA look to information technology.
He raised the idea of better integrating REMS communications into electronic medical records.