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.

If The Candidates Were Drug Names...

If the presidential candidates were pharmaceutical products, what would they be called?

That was the question posed by American Public Media’s Weekend America, and here’s what Jim Singer, president of the brand naming firm Namebase (developer of Fruitopia, the Kia Rondo and Lilly's Prozac) came up with for the four leading presidential candidates:

Barack Obama, Singer said, stands for "change and hope," so his drug name would be Hopium. (Given Obama's past drug dabbling, we think that's a pretty smart pick.) Weekend America even came up with the snazzy logo above.

As a woman, Hillary Clinton needs to "constantly prove that she's tough," especially on an issue like terrorism, Singer said. So for Clinton, he chose two names that incorporate the morpheme "tuff": Tuffarelle and Tuffagra.

John McCain's position on the troop escalation in Iraq inspired his drug name: Escalatra.

And finally, given that Mike Huckabee is an evangelical Christian, his drug name would be Zelotra, or Zelotene, Singer said.

While the Weekend America piece was a fun exercise, drug marketers know that picking a brand name is no laughing matter--especially given the fact that FDA is rejecting more proposed propietary names these days than in the past. Luckily, the reauthorization of the user fee agreement last year includes fixes that will make the whole process a lot more predictable.

Singer offered some insights into how Namebase comes up with brand names for their clients: "We sit around a table and think up good-sounding words, and then we take them apart and try to sell them to the clients afterwards with a lot of science behind it. But really we're just kind of babbling in there, and when a good one comes out, we write it down."

Hmm. Given the description of that super-scientific exercise, what can you come up with? Send us your suggestions.

Get on the Brand Wagon

The new rules of drug safety mean that sponsors will have a lot to think about when they submit an NDA to the Food & Drug Administration. But while there’s a lot of new policy coming, companies shouldn’t overlook changes to the way they make one of their most basic decisions—what to call a newly approved product.

The brand name is a small part of the overall NDA. But it’s quite unsettling when FDA denies a sponsor its preferred option for a new drug name—sometimes wiping out years of brand name recognition. (Sanofi-Aventis’ obesity drug rimonabant—Zimulti, née Acomplia—is a good recent example.) And there’s always the odd case of a product that’s approved without an agreed-upon trade name—a disaster for any marketing department.

The Onion, of course, was way out in front of this

The process by which companies obtain FDA approval of a proprietary name has been pretty straightforward. Drug companies submit up to two names for review, and the agency tests for potential medication errors, as well as false and misleading claims. Sponsors can usually expect to hear back from FDA within 90 days of the user fee date—but there are always examples of reviews that take much longer.

But all that’s about to change.

Under a pilot program proposed in the Prescription Drug User Fee Act reauthorization package, the responsibility for testing brand names would shift from FDA to the drug sponsor. In exchange, FDA would commit to completing its review within a set time period. In essence, that would make the system more predictable for drug sponsors—albeit a bit more expensive. The RPM Report has covered this topic extensively; for more complete coverage, read this story and this story.

Want to learn more? The RPM Report is co-sponsoring an audio conference on this very topic with the Food & Drug Law Institute next week. Experts from FDA and industry will be on hand to answer all your questions about the changes to—and challenges of—getting a drug name vetted by the agency.

Our expert panel includes Debbie Henderson, FDA’s director of executive programs at the Center for Drug Evaluation & Research; Jerry Phillips, director of the Drug Safety Institute and the former head of FDA’s Division of Medication Errors & Technical Support; and Bob Lee, assistant general patent counsel at Eli Lilly.

The audio conference, “Naming Drugs: The Pharmaceutical Brand Name Challenge,” will be held on Wednesday, July 18 from 1 pm-2:30 pm. Registration information can be found on FDLI’s website at http://www.fdli.org/conf/413.