FDA may want to standardize Risk Evaluation and Mitigation Strategies, but that would not mean sponsors should expect each will be exactly the same.

A major problem with the REMS process is the belief that each REMS is designed and negotiated from scratch "like it is the first time it ever happened," Robert Clark, Pfizer vice president of worldwide regulatory strategy, said Dec. 9 during a panel discussion at the FDA-CMS Summit for Biopharma Executives. Clark and other industry members as well as trade organizations have asked for standardized REMS.

The agency already is looking at ways to standardize the REMS system so sponsors can learn from prior experience and speed up the process. CDER Director Janet Woodcock said the objective was a "plug-and-play" REMS.

But Office of New Drugs Director John Jenkins said plug-and-play does not necessarily mean one REMS program will exactly translate to another product.

"Plug-and-play doesn't mean that everything's the same, it means that it's compatible," Jenkins said. "So when you plug in the device into your computer, it doesn't mean that that's the same device you plugged in yesterday, or the same device you'll buy tomorrow brand new, it means that it's compatible, it's interoperable. I think that's the goal for what [Woodcock] is talking about."

The agency conducted a public hearing on REMS improvements in late July where Woodcock said the agency should move to a more unified system that can be utilized by various sponsors.

Pharmacist groups during the hearing also called for specific templates to better anticipate and implement the programs, which the agency supported (Also see "REMS And Benefits? FDA, Industry Debate Moving Beyond Safety Information" - Pink Sheet, 2 August, 2010.). Woodcock at that time also said she supported limiting the number of different types of REMS that could be implemented (Also see "REMS Templates Get Nod From FDA, With Nudge From Pharmacists" - Pink Sheet, 28 July, 2010.).

Clark said many REMS are not practical in terms of the record-keeping, training and work required, especially when a small number of patients use the drug. He guessed the cost of implementing the REMS was more than the company was making with one the drug that has restricted access.

Jenkins said he thought there were ways to use the existing pharmacy payment computer system as part of the REMS standardization effort. He said pharmacists already have access to patient insurance information that shows information like which drugs are covered by various insurance plans. Rather than employing a separate system to administer the dozens of existing REMS, as is done now, Jenkins argued that pharmacist payment system could be used to include risk management as well.

Woodcock also said she did not know when the framework for improved REMS could be completed.

Divorcing MedGuides From REMS

In the short-term, Jenkins said the agency wants to cut down on the number of REMS that only include Medication Guides. Since FDA had authority to require medication guides before approval of the FDA Amendments Act, which established the REMS program, Jenkins said the agency wants to establish uses for pre-FDAAA and post-FDAAA medication guides.

"The hope is that we can issue a guidance that will define when we will apply the existing regulatory framework for a medication guide and when we will apply the new FDAAA-related framework for the medication guide," he said.

Jenkins said assessments are showing that Medication Guides are not being distributed by pharmacists and creating a lot of infrastructure and bureaucracy that is burdensome.

"It's the gift that keeps on giving and we would like to find a way to get out of and only use Medication Guides as part of REMS when its part of other components of the REMS," he said.

When a question was asked whether requiring REMS with Medication Guides for all products made sense as a method to spur faster creation of the necessary infrastructure, Gerald Dal Pan, director of the Office of Surveillance and Epidemiology, said the new patient medication information under development could accomplish that premise without adding a lot of burden to the surveillance system.

The PMI would place all necessary information about a drug in one document that theoretically would be more understandable for patients that the existing literature that comes with prescriptions. Dal Pan said that document could provide Medication Guide-type information for all drugs.

-Derrick Gingery (d.gingery@elsevier.com)

FDA's Long-Term Vision For REMS Includes "Plug-And-Play" Standardization

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