New website streamlines REMS data

FDA has launched REMS@FDA, a new version of its Risk Evaluation and Mitigation Strategies (REMS) website that standardizes data on drugs and biologics, and provides other, more detailed information for pharmacists and other healthcare providers.

FDA transformed the site after identifying it as a priority project under the Prescription Drug User Fee Act (PDUFA).

“There was not much consistency in how the documents are presented, and they have a lot of regulatory terminology that can be confusing,” said Adam Kroetsch, MSPPM, operations research analyst for FDA’s Center for Drug Evaluation and Research (CDER), during an FDA webinar earlier this week. “The variation [in each drug’s REMS] makes it difficult for stakeholders to adapt when new REMS come online.”

See also: OIG examines overal effectiveness of FDA's REMS program

Searchable and sortable

On the new site, health-systems pharmacists, researchers, the public, and others have access to a searchable and sortable table of current REMS programs. In addition, pages on specific REMS products provide much more detailed information, said Amy Ramanadham, PharmD, MS, director of CDER’s Office of Communication, Division of Drug Information (DDI). 

“There are links to all the approved REMS, and the first two columns are sortable. We took great care to enhance the quality of data,” Ramanadham said. Website users can search for REMS by drug name, element, communication plan, shared system, application number, and other factors that will help them obtain the results they need more quickly.

New features

When users visit a REMS-specific page, a link to the product’s label and medication guide is now included, if available, along with links to relevant regulations. Under each specific REMS, physicians and pharmacists can click on the “What do participants need to do?” links, which will orient those “who want to quickly understand what the REMS program does,” Kroetsch said.

When pharmacists and other users choose to download data on specific REMS, they will find that the information is now presented in a more comprehensive format. Instead of finding only one large PDF file available for download, users will find that material pertaining to each REMS has been split up, enabling them to download just the information they need.

Users can also access historic information about each REMS, including FDA approval letters and primary source documents “to identify how the REMS has changed over time,” Kroetsch said.