REMS Standardization Could Help Opioid Education Efforts

FDA is hoping to begin the transition to a more standardized REMS format in the coming weeks.

The agency wants to begin accepting REMS documents in structured product labeling (SPL) format this summer, Adam Kroetsch, an operations research analyst in FDA’s Office of Planning and Informatics, said June 7 during a meeting on a standardized REMS program sponsored by the Duke-Margolis Center for Health Policy.

The new format would be a significant step forward for efforts to bring Risk Evaluation and Mitigation Strategies into a common platform and better integrate the plans into the health care practice. However, it appears a number of steps remain before the new common REMS platform is widely adopted, even though stakeholders are not designing it from scratch.

FDA, as part of the 2012 prescription drug user fee reauthorization, agreed to research ways of better incorporating REMS into the health care system (Also see "REMS Integration Into Electronic Medical Records Mulled By FDA" - Pink Sheet, 23 Jul, 2015.).

Since being established in the 2007 FDA Amendments Act, REMS have created in some cases heavy burdens on industry and providers despite their ability to allow more risky products on the market.

The number of REMS approved have decreased in recent years, although those that are approved now tend to include the restrictive provisions called Elements to Assure Safe Use (Also see "FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures" - Pink Sheet, 12 May, 2014.).

But even though there are fewer REMS being created, FDA has been looking for ways to ease the paperwork, evaluation and other hassles.

One of the ideas is to submit REMS documents and data in SPL format so they could more easily be shared online and added to health care systems. It also joins REMS with the existing drug information infrastructure.

The agency just completed a pilot project using the REMS SPL format that included nine drug sponsors. It now is finishing materials and an implementation guide so it can eventually open the system for broader use.

Kroetsch said after his presentation that FDA’s goal is to begin accepting REMS documents and data elements in SPL format this summer.

The agency does not have any plans to convert the existing REMS plans to SPL format, however, which likely will leave FDA with programs in legacy as well as in SPL formats. But Kroetsch said FDA would encourage sponsors of existing REMS programs to voluntarily convert them.

Still, once the new system takes shape, using SPL format for REMS material likely will be considered a tacit requirement if not a specific one. And if the new format leads to new efficiencies, sponsors likely will quickly convert their legacy REMS to the new system.

SPL format allows the REMS documents to be coded with standard data elements that health IT systems can read. They can be shared throughout the health care system on Daily Med and eventually incorporated into hospital and other practice tools.

The SPL format pilot project began in 2015. That year FDA also launched a new REMS website, REMS@FDA, which includes up-to-date information on all existing REMS programs, but the agency also is looking for ways to make the entire system more patient-friendly (Also see "FDA REMS Reforms Lacking Patient Engagement So Far" - Pink Sheet, 16 Jun, 2015.).

Platform To Use Existing Standards

Moving REMS programs to SPL format is another advance toward the ultimate goal, which is a common REMS platform with standardized elements and tools.

A number of data and other standards will be needed to launch the common platform. FDA and industry are hoping to integrate standards industry already uses to minimize the need to create and adopt new ones.

“I think we’re blessed in trying to solve this REMS technical standard problem by having so many standards by very mature groups that are available to be used already,” Paul Sheehan of Celgene Corp. said during the conference.

Kroetsch also said that much of the common platform will evolve gradually.

“I don’t think there’s a hard date that I can give you that says this is the day we introduce the platform,” he said. “It’s going to be an ongoing process.”

FDA is hoping that using existing standards, as well as implementing a common platform, will make REMS much easier and cheaper to develop.

Advocates still will have to make a case for a financial return on investment with the common REMS platform, several speakers indicated during the meeting.

Existing systems would not require much reconfiguration; however there still have been questions about how such a project would be funded (Also see "FDA REMS Platform Will Make Safety Plans Easy – Maybe Too Easy?" - Pink Sheet, 7 Oct, 2015.).

One option could be tapping PDUFA VI revenue, but with negotiations concluded, it is unclear whether FDA and industry decided to dedicate additional funds to the project.

Unlike PDUFA V, the next commitment letter does not appear to have a number of changes included (Also see "PDUFA Negotiations End, Approval Process Ongoing" - Pink Sheet, 26 Feb, 2016.).

Opioid ‘Use Case’ In Development

FDA also continues to build so-called “use cases” for its REMS platform that illustrate how a common platform could solve specific problems.

Kroetsch mentioned one under development involving the long-acting and extended-release opioids REMS prescriber training component. He said FDA is considering how the platform could be used to verify prescribers had completed the necessary training.

Kroetsch also said the SPL system could help distribute REMS material, as well as provide information on where prescribers can obtain the necessary training.

“That’s possible through the SPL to populate that prescriber’s … electronic health record and alert them to the need to do that kind of training,” he said. “And then the REMS platform can be used to help the prescriber send evidence that they completed that training to the drug manufacturer and that evidence can then be forwarded on to the dispenser so that they know that the patient has been prescribed the drug by a prescriber who has received the education.”

Opioids regulation has become a hot-button topic in recent months. During Commissioner Robert Califf's confirmation process, the agency released a new plan to boost its fight against opioid abuse following criticism of its lack of action (Also see "FDA's Opioid Action Plan Could Clear Califf Nomination Roadblock" - Pink Sheet, 4 Feb, 2016.).

Among the plan’s provisions was to review the ER/LA opioids REMS, including the prescriber training component. An advisory committee voted in favor of making the training mandatory (Also see "Restrictive REMS Is Least Favored Path For Opioid Prescriber Education" - Pink Sheet, 9 May, 2016.).

FDA has looked at a number of ways to enhance providers’ understanding of REMS programs.

One suggestion was to offer continuing education credits to encourage providers to take the associated training courses (Also see "REMS Enhancements Could Include Provider Education Credits" - Pink Sheet, 23 Sep, 2014.).

An advisory committee also said official REMS letters and other material should include a special logo to help them gain providers’ attention (Also see "REMS Communications Need FDA Logo To Boost Doctors’ Attention, Advisors Say" - Pink Sheet, 23 Dec, 2013.).