Back when Vertex won FDA approval for its blockbuster hep C drug telaprevir, there was a good deal of hooting on Twitter when the commercial name--Incivek--hit the wires. One high-profile writer made a quip later about an Eskimo name. But looking over a new report on naming new drugs, the biotech company may have been more than happy that it had a trademark on a name acceptable to regulatory authorities.
According to Thomson Reuters, the FDA has become increasingly hard to deal with when it comes to approving a new drug name. Vexed by previous safety issues with drug names that looked too much alike for pharmacists puzzling out a doctor's scrawl on a prescription, the agency's rejection of suggested trademarks for new drugs has climbed from 30 percent to 36 percent in recent years. Add in the EMA to the process, and biopharma companies are looking at a rejection rate of close to 50 percent. And then there's the issue of juggling approvals at the patent office--marking a three-step hurdle.
Because no one wants to get caught at the regulatory finish line with a new drug and no commercial name, the naming process now typically starts at the end of Phase I, according to the experts who talked to Thomson Reuters. And once they get 200 to 300 (!) possible monikers, they start the winnowing out process, aiming for 5 to 10 trademarkable names that can be filed and approved 12 to 24 months ahead of the approval timeline.
As with everything about the FDA, the best cure for a naming headache is plenty of face-to-face dialogue with regulators along the way. And now there's a pilot program under way that is designed to come up with a set of best practices on the subject. You can see the report here. And we'll be talking about the ins and outs of working with regulators at our upcoming executive breakfast on developing a regulatory strategy at BIO 2011 on June 29. I hope to see you there. - John Carroll (email | Twitter)