Included in FDA's upcoming look at improving Risk Evaluation and Mitigation Strategies may be an adjustment to Medication Guides to include drug benefits alongside risks.

Industry members and trade groups said during a July 27-28 public meeting on the REMS process that the lack of benefit information was not allowing balanced communication and could sway patients away from taking essential medications.

Yet the prospect of simply adding additional statements to the MedGuide did not overly impress agency officials. They raised logistical issues, like avoiding promotion and dealing with off-label use that could complicate efforts.

Carmen Bozic, Biogen Idec senior vice president and global head of drug safety and risk management, said drug benefits should be included in the Medication Guide as well as other elements of the REMS.

"If there's an enrollment form for your program where the prescribers and patients have to attest to understanding the risks of the drug, they should attest to understanding the benefits as well," Bozic said.

Preventing MedGuides From Becoming Ads

John Jenkins, director of the Office of New Drugs, said any benefits presentation ultimately could lead to claims it was a drug advertisement. He also wondered how the agency would address off-label drug uses if benefits become part of the MedGuide.

"Would it be basically a summary of clinical trial experience that's in the label?" Jenkins asked. "How would you make that patient-friendly and get around what I'm sure would be our concerns that this would be promotional?"

Sponsors have negotiated indication information into some patient package inserts, essentially getting them to state what the drug does, said Glenn Naphy, managing director of Springboard Associates. That format could serve as a template for adding benefit information to a Medication Guide, he said.

Bozic was unsure how off-label benefits should be handled, but said all she envisioned were a few lines indicating why the drug could help a patient. She said clinical trial consent forms already have similar benefit information included.

"I think there is a way to do it in a very simple way to add in amongst the lengthy list of risks a couple of bullets," Bozic said. "I'm not saying it should be 75 percent of the enrollment form, but a few additional points that explain ... the benefits that they might anticipate receiving with this drug."

Jeffrey Francer, assistant general counsel of the Pharmaceutical Research and Manufacturers of America, said the off-label benefit responsibility should be left to health care providers.

"I think all we're asking for is inclusion of a patient-friendly version of the FDA-approved indication," Francer said.

Francer also called for FDA to stop implementing Medication Guides through the REMS process to eliminate some sponsor burdens (¹ Also see "PhRMA Wants MedGuides Developed The Pre-FDAAA Way, Not Through REMS" - Pink Sheet, 26 July, 2010.). Currently, all MedGuides are automatically handled as a REMS.

Standard MedGuide, REMS Processes Coming

The Medication Guide discussion came in the midst of debate about how to better standardize REMS programs.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, opened the REMS meeting saying the agency would begin looking at ways to standardize the REMS system this fall.

Pharmacist groups asked FDA to decide on REMS templates so they could better anticipate how the programs could be integrated into their systems (² Also see "REMS Templates Get Nod From FDA, With Nudge From Pharmacists" - Pink Sheet, 28 July, 2010.).

Woodcock said because drug sponsors propose REMS programs, there is not enough standardization. "I strongly feel this is where we need to go," she said, "into a more single system ... that can be utilized by various sponsors to initiate REMS."

Woodcock also said Medication Guides are not an optimal way of conveying information and that the agency would move forward with creating a patient information leaflet.

Stakeholders critiqued a prototype for a single document for patient information last year, after an advisory committee recommended a single document be dispensed. But Deborah Henderson, director of CDER's Office of Executive Programs, said other solutions were possible (³ Also see "Single Patient Drug Leaflet Logical, Complicated To Achieve - Woodcock" - Pink Sheet, 5 October, 2009.).

Consolidation of patient information into one document is not as important as ensuring patients can understand what is in that document, said William Vaughan, a health policy analyst with Consumers Union.

"It really should not be considered a burden to provide an accurate label and package insert-type document - certainly not a burden that justifies complaints," Vaughan said in written testimony.

"The real issue with [Medication Guides] and other informational papers that come with prescriptions is that they remain too complicated for many laypersons and often appear ineffective," he said.

- Derrick Gingery ( ⁴ d.gingery@elsevier.com )

REMS And Benefits? FDA, Industry Debate Moving Beyond Safety Information

More from Archive

More from Pink Sheet