A proposed FDA pilot program that would shift the burden for safety review of proprietary drug names from the agency to industry needs to account for key differences between OTC and Rx products and lacks participation incentives, pharmaceutical researchers say.

FDA is developing a voluntary pilot program to reduce medication errors related to look-alike or sound-alike drug names and to "error-prone label and packaging design." In the pilot, drug companies would thoroughly evaluate the safety and appropriateness of proposed product names before submitting their requested names to FDA, which would then review firms' research and judge the names.

The proposed pilot would review research for Rx-to-OTC switch product names submitted in initial new drug applications and products with biologic license applications or abbreviated new drug applications. It would not review proprietary names for OTC monograph products, which the FDA does not approve prior to marketing.

The pilot will make the agency's review process "more efficient," because firms will use "best practices" outlined by FDA to evaluate and "avoid names that are misleading or ... likely to lead to medication errors," FDA says in a draft concept paper for the pilot (see chart: " ¹ Buckle Up For Brand Take Off: FDA's Checklist For Pilot Participants ").

A more efficient review for FDA does not mean the agency will expedite its decision about a name that goes through the pilot, Jerry Phillips, president and CEO of the Drug Safety Institute and former associate director of FDA's Office of Drug Safety, said in an interview.

Rather, he noted, the agency will stick to the 90-day review deadline for NDA and BLA name submissions as laid out in the Prescription Drug User Fee Act IV. The agency says it also will try to review names submitted as part of an ANDA or IND within 180 days, according to the concept paper.

Address OTC Issues

A firm seeking an Rx-to-OTC switch that wants to participate in the pilot may not be selected. FDA plans to review 25 to 50 proposed proprietary name submissions under the two-year pilot, which will begin by the end of fiscal 2009. This breaks down to one or two submissions reviewed by FDA per month, according to the concept paper.

The proposed pilot is a work in progress and industry leaders at a public meeting June 6 suggested several changes to address the unique features of OTC drugs approved through the switch process.

Some industry representatives suggested FDA scratch proposed simulation scenarios that test practitioners' response to a proposed name by asking them to use the name in simulated real-world conditions.

For example, panel members said scenarios that test whether the name inappropriately promotes a product or could mislead consumers may be unnecessary for nonprescription products because companies already conduct extensive consumer comprehension tests to ensure consumers can safely self-select a product based on the name and label.

In addition, a simulation study that compares a product name to others when handwritten may not be as necessary for OTC products as it is for Rx drugs, which are often identified on health care providers' handwritten prescriptions, Ruth Day, head of Duke University's Medical Cognition Laboratory, suggested at the meeting.

However, because practitioners often write orders for nonprescription drugs that nurses fill for inpatients, the simulation study may be necessary, noted Michael Gaunt, a medication safety analyst with the Institute for Safe Medication Practices.

Panel members also suggested FDA include consumers in the simulation tests because they will buy most of the OTC products.

From a promotional perspective, FDA should give OTC product names "more latitude" than it might give prescription products, Phillips said.

Under the proposed pilot, firms must test whether a name "contains misleading implications" by asking consumers what they think of the name.

However, Phillips said FDA should allow OTC product names to be more promotional and have more positive associations or connotations than Rx names because the OTC sales environment is more competitive and consumers are the main users.

Panelists said that for OTC products, FDA also may need to rethink a stance stated in the draft concept paper, that "there is no acceptable background rate for a preventable adverse drug event resulting from a medication error due to name confusion."

"Setting a zero-error rate may be a worthy goal, but it is not going to be what you find," said Eric Brass, a professor of medicine at David Geffen School of Medicine at UCLA. He explained at the meeting that "in the OTC area ... there is no behavior you can imagine that won't occur."

Costs Pose Barrier

Another participation barrier for firms may be costs. While firms do not pay to participate in the pilot funded by PDUFA IV user fees, the program's requirements "will likely lead to greater costs for sponsors in terms of time and money," said John Breen, research director for rxmark, the research division of Interbrand Wood Healthcare.

He explained that "the study design currently proposed for the name/promotional reviews as outlined in the concept paper involves implementing multiple research methodologies that will require a larger pool of study participants to meet minimum statistical thresholds in comparison to current industry best practices."

Another "major" challenge with the proposed pilot is "that despite putting a proposed trademark through this more in-depth and costly evaluation, a company still may not be able to predict a favorable outcome, in terms of ultimate approval of the name," Breen said.

"As a result, there may be little incentive for companies to participate in the pilot program, as it does not necessarily increase the likelihood for success."

Even though the pilot doesn't guarantee approval, it may lead to a higher FDA acceptance rate of names, Phillips observed.

He explained that pilot participants will better understand how FDA evaluates names and will submit "more robust data" about their proposed name. This could lower the agency's rejection rate, which currently hovers between 35 percent and 40 percent, he said.

Another "key incentive for companies to participate is that they should have the opportunity to help shape the direction of the program, should it be ratified as a standard practice in the future," Breen said.

"If the FDA truly views the pilot program as an opportunity to collaborate with industry in an effort to understand the role of the trademark in the overall medication error paradigm, then forward-thinking sponsors may look to participate in order to have a voice in this ongoing discussion," he added.

- Elizabeth Crawford (e.crawford@elsevier.com)

FDA’s Proposed Name Review Pilot Offers Little Reason To Participate

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