Friday, June 06, 2008

FDA Brand Name Review: Finding Predictability in the Process

When it comes to FDA regulation, the top priority of any drug sponsor is finding predictability in the system. Sponsors want to know that if they follow a specified regulatory process, it will result in a predictable (and hopefully positive) outcome.

But that’s precisely what some pharmaceutical companies think is lacking in FDA’s proposed redesign of the brand name approval process.

Right now, the process by which FDA approves proprietary trade names is pretty inefficient: about 40% of brand names proposed by sponsors are rejected by the agency for safety or promotional reasons. (We wrote about this increased rejection rate in a previous story in The RPM Report.)

FDA is hoping to improve things by transferring the responsibility of testing proposed names to drug sponsors, starting with a pilot program negotiated under the last reauthorization of the Prescription Drug User Fee Act. Much like the NDA review process, sponsors would test their preferred names themselves and submit that information to FDA for approval.

The agency held a two-day meeting on the pilot on June 5-6 to gather feedback on a concept paper outlining how the new program might work. One major concern was echoed repeatedly throughout the two-day meeting: that the redesign of the brand name approval program will slow down the process and lead to higher rejection rates.

Novartis VP Trademarks & Copyrights Steven Hartman, one of several industry representatives on the meeting panels, made this point repeatedly. As proposed by FDA, the revised process outlined in the concept paper would require sponsors to do a lot of extra work, he noted. What confidence does a company have that if it finds a name to be acceptably safe, that FDA won’t simply disagree with that conclusion?

Not much, acknowledged Carol Holquist, the director of FDA’s Division of Medication Error Prevention & Technical Support.

“I can’t say that any data that you submit will be rubber-stamped based on your analysis,” she told Hartman. “We would have to evaluate it, just as we would any clinical trials data. We would never be able to officially endorse [a name], and say if you followed the concept paper to the hilt, that we will automatically accept the results verbatim.”

That wasn’t exactly the response Hartman was looking for. “Unless we move toward a scenario in which the agency is willing to place some significant weight on the outcomes that a sponsor submits,” he said, “predictability will decrease.”

Holquist disagreed, arguing that over the long term, the revised approval process will allow FDA to become “more transparent about the reasons why we’re saying no.” If we learn from those reasons,” she said, “the predictability may increase.”

The idea that the revised program “may” increase predictability isn’t likely to offer any immediate comfort to drug sponsors. Luckily for industry, FDA appears quite open to making changes to the program. And given the number of drug company representatives invited to participate in the two-day meeting, industry will have many seats at the table.

image 'Old Faithful' from flickr user James Neeley used under a creative commons license.

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