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 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.