REMS Communications Need FDA Logo To Boost Doctors’ Attention, Advisors Say

Risk Communication Advisory Committee suggests that adding the agency imprimatur to REMS materials may help distinguish it from promotional mail and ensure providers read the communications.

FDA could add a more visual symbol of its approval of REMS materials and communications in order to entice more providers to read them, members of the agency’s Risk Communication Advisory Committee suggested Dec. 17.

FDA is looking to improve Risk Evaluation and Mitigation Strategies’ impact among providers, including better efforts to ensure that “Dear Healthcare Provider” letters and other information about new or changed REMS emerge from the growing pile of paper and email physicians receive.

The agency should lend the power of its brand to REMS communications, such as including its logo on the letters or other material to improve their effectiveness, panelists said.

FDA approves all REMS materials before they are disseminated, but only the product sponsor is on the letterhead. Agency officials are worried many of those letters go unread because they are thought to be product promotion.

“It’s very clear that the FDA has much higher credibility than any pharmaceutical company,” said Vicki Freimuth, University of Georgia. “If there would be a way that the letter could appear – even if it doesn’t actually get sent out by FDA – that it appears to be from FDA … I think that would be a great asset.”

Brand, Sub-brand Or Asterisk?

But while FDA’s logo likely would increase the credibility and attention that a REMS letter would receive, it also potentially could hurt the agency’s reputation. Nananda Col, of Shared Decision Making Resources, said FDA built its reputation by distancing itself from industry. She wondered if the agency’s credibility could be affected by placing its logo next to a drug company or product logo in REMS letters.

The agency could create a sub-logo – one that would not be the iconic “FDA” logo, but specifically for REMS. It could be separate, but still easily identifiable as agency-approved, members suggested.

Gavin Huntley-Fenner, CEO and Senior Advisor of Huntley-Fenner Advisors, said FDA’s sub-brand would emphasize “that FDA has approved the message and that this is not a simple marketing communication, but also protect the core FDA brand.”

Acting advisory committee Chair William Hallman, Rutgers University, said the agency also could require a symbol be attached to the product name so it would be made clear across all product materials that it has a REMS.

“What I’m envisioning is something akin to an asterisk that could be attached to the name of the drug,” he said. “Some sort of symbol that would indicate whenever the name of a drug appeared that there was some indication that there was a REMS associated with it.”

The concept of a graphic signifier for risk information has been proposed by both FDA and industry.

FDA had floated the idea of requiring an inverted black triangle next to the name of new products as part of its labeling redesign that created the “Highlights” section, but opted instead for making the dates of product approval and label updates more prominent (Also see "Labeling “Highlights” To Depend On Data In Relation To Clinical Setting" - Pink Sheet, 23 Jan, 2006.).

In a separate proposal, the Pharmaceutical Research and Manufacturers of America suggested that basic risks about drug products could be included in online search results through an icon that would link to the full prescribing information (Also see "PhRMA's Web Search Solution: Add Icon Or Generic Risk Statement In Results" - Pink Sheet, 9 Nov, 2009.).

Should There Be An App For That?

Icons of a different kind were also on the committee’s mind as smart phone apps and email seem poised to become a more popular method to disseminate information about REMS, given that printed letters no longer command as much attention as before.

David Berube, North Carolina State University, said the agency could design a smartphone/tablet app that providers could use to access pertinent REMS and other risk information.

The app could allow a constant flow of information and easy links to other REMS documents and updates. Berube said the information would be more easily accessible and on a platform that more providers are embracing. Use also could be tracked more reliably to determine whether providers are viewing REMS material.

“It would be an open public resource,” Berube said. “The application could include incentivizing features where every time you go to use the smartphone or tablet application the registry could be tracked ... You also could build into the application program a direct link to your assessment matrix. It’s just a good way to look at a complicated problem in the 21^st century.”

Paul Harwood, of Twitter Inc., suggested email as a way of getting information to a provider’s computer, tablet or smartphone. Messages also could be tracked to determine whether they were opened, which would allow an effectiveness comparison to printed mail.

Harwood also said social media could play a role, although he did not mention his employer directly as an example. He said LinkedIn can allow easy dissemination of documents through its professional groups and others may be advantageous because they allow easy message sharing.

“Some of them where [there is] sharing and sending on the message again, you would be able to give your stamp of approval to a message that originated from the company and share it on,” Harwood said.

Email may be gaining ground as a mode of communicating REMS information, although hard copy mail still dominates.

An FDA review of 30 REMS programs found all of the sponsors sent hard copy letters to providers, while only eight sent the information electronically, such as via email or fax. Nearly all of them posted the information on a website dedicated to the risk management program and all but one of the REMS programs used more than one dissemination method (see chart).

REMS Communication Dissemination Methods
An FDA review of a sample of REMS programs found that most did not send information to providers electronically.
Communication Technique	Programs using it
Hard copy mailed to individual providers	100%
Posted on REMS-dedicated website	97%
Field representatives or medical science liaisons	40%
Mailing to professional societies	33%
Electronic mailing (email or fax) to individual providers	27%
Professional meetings or conferences	20%
Medical journals	17%
MedWatch	17%
Medical information department	13%
Call center	13%
REMS training	13%
Note: Thirty of the 66 REMS programs for individual drugs were included in the review. Source: FDA

Simplification vs. Innovation

Kate Oswell, an FDA health communication analyst, said sponsors recently tried sending emails with REMS information first and if a provider did not open the message, they follow up with a printed copy. Oswell works in the FDA Center for Drug Evaluation and Research’s Office of Medication Error Prevention and Risk Management’s Division of Risk Management.

Industry also may be able to help FDA improve REMS communications quality, if mandated by FDA. Rajiv Rimal, of George Washington University, said an agency requirement that sponsors ensure a certain percentage of providers read REMS communications could spark innovation in the space.

“I would imagine that they would come up with many more creative ideas on how to do so than what is typically a very large organization like the FDA, which is not known to be very nimble,” he said. “I think the sponsors probably could be.”

Industry may not enthusiastically embrace such an idea. PhRMA already has said FDA should lead efforts to assess REMS’ burden on health care (Also see "Whose Burden Is It Anyway? REMS’ Health Care Impact Belongs To FDA, PhRMA Says" - Pink Sheet, 12 Aug, 2013.).

Industry has called for REMS to be simplified in part because of the extensive assessment requirements attached. Standardizing REMS for better integration into the health care system also was one of the goals included in the 2012 prescription drug user fee reauthorization (Also see "REMS Communications Could Get Refreshed After Advisory Panel Meeting" - Pink Sheet, 4 Dec, 2013.).

FDA wants to create a plan to assess REMS components and no longer rely on surveys following a Department of Health and Human Services Office of Inspector General report (Also see "FDA Plans To Improve REMS Effectiveness With Guidance On Goals And Metrics" - Pink Sheet, 18 Feb, 2013.).

FDA also is considering a pilot project that will look at how FDA can encourage providers to include information about a medication’s benefits when counseling a patient (see related story, (Also see "FDA “Reminds” Doctors To Talk About Drug Benefits" - Pink Sheet, 23 Dec, 2013.)).

A Standardization Step

Improving REMS communication updates also should feed into efforts to better standardize them and ease their burden on sponsors and providers.

During a two-day meeting on the subject in July 2013, using the structured product labeling format was suggested as a way to ensure REMS language is consistent across programs (Also see "How To Speak REMS: Structured Product Labeling Seen As Route To Standardization" - Pink Sheet, 12 Aug, 2013.).

Gary Slatko, director of the CDER Office of Medication Error Prevention and Risk Management, said during the advisory committee meeting that guidance looking to better standardize how program roles and objectives are determined is in development.

Slatko said a report based on stakeholder feedback on how best to standardize REMS also is in development and likely will be issued in 2014.

Among the problems with determining the effectiveness of a REMS has been finding metrics (Also see "REMS Need Metrics For Assessing Success, Burden On Health Care System" - Pink Sheet, 30 Jan, 2012.).