PhRMA Wants MedGuides Developed The Pre-FDAAA Way, Not Through REMS

Using 1998 authority would reduce the burden on sponsors, physicians and patients, industry group says.

To improve the REMS process, the Pharmaceutical Research and Manufacturers of America will call on FDA to revert back to its pre-FDAAA authority to implement medication guides.

FDA's initial authority to require a medication guide to mitigate risk came in through a final rule in 1998 (Also see ""MedGuides" Required Only In Classes Where Patient Info Already Requested" - Pink Sheet, 7 Dec, 1998.), but now also resides within the FDA Amendments Act of 2007 as part of the Risk Evaluation and Mitigation Strategy program.

PhRMA said writing medication guides outside the REMS process would reduce paperwork and third-party surveys that come with implementation through the REMS process.

Jeffrey Francer, PhRMA Assistant General Counsel, said the medication guide would remain part of the product label development process under the group's plan.

"What we're trying to do is to mitigate some of the burdens especially on patients in addition to the FDA and companies that are now using, I think, the somewhat awkward REMS framework for implementing an authority that FDA has had since 1998," Francer said.

PhRMA will make the recommendation July 27 and 28 during an FDA public meeting on REMS. The agency plans to use comments from the meeting to help formulate more guidance on REMS for drugs.

The industry group latched on to the idea after hearing FDA was open to it. John Jenkins, director of the FDA Office of New Drugs, last month told a session of the Drug Information Association annual meeting the agency was looking for a creative way to interpret that part of FDAAA.

Jenkins said the administrative burden is large, not only on sponsors, but also pharmacies and society (Also see "FDA Seeks To Write MedGuides Outside REMS Process" - Pink Sheet, 21 Jun, 2010.).

Medication guides are by far the most popular REMS. As of June 30, 86 of the 129 REMS approved by FDA included only a medication guide.

"Typically when FDA has been inserting medication guides into the REMS framework, FDA asks for an evaluation with respect to how the medication guides are working," Francer said. "In addition they have to have pretty defined effectiveness goals and additional approval documentation. So this is a number of additional requirements for something - medication guides - that quite frankly aren't new."

Francer said no legislative changes would be needed to implement medication guides outside the framework set by FDAAA.

"Our reading of the law is that FDAAA allows them to use REMS but doesn't mandate that they use REMS for medication guides," he said.

REMS Need More Justification, PhRMA Says

PhRMA also wants FDA to better explain benefits and risks and why it is requiring a REMS for a specific drug its in REMS action letters. The agency also should give its reasoning for choosing certain REMS aspects over others and what they do to mitigate risks and outline why other risk management tools are not sufficient, the group said.

In addition, FDA should explain in the action letter how it came to the conclusion a REMS was necessary and what burdens it thought the REMS could place on patients and health care professionals, PhRMA said.

Francer said physicians have been confused by how FDA chooses specific risk mitigation strategies.

"I think what they're seeing ... is that they have seen some inconsistency regarding specific elements and different types of risks," he said.

Prescription Drug User Fee Act negotiations, now ongoing, also could serve as a vehicle for REMS program adjustments.

Industry and patient groups asked for REMS improvements during the initial public meeting for the 2012 PDUFA renewal, including initiating development planning earlier to avoid review decision delays (Also see "Earlier Attention To REMS Could Keep Drug Approvals On Schedule, Industry Says At FDA Meeting" - Pink Sheet, 12 Apr, 2010.).

-Derrick Gingery ([email protected])