June 2008, Vol. 3, No. 12
By Kate Rawson
FDA’s proposed changes to the brand name review process aren’t immediately winning the support of drug sponsors, who fear that the new program would lead to longer, less predictable reviews.
FDA acknowledges the process may initially lead to longer review times, but believes that in the long run, it will result in faster, more predictable reviews for industry. And with FDA rejecting about 40% of proposed names, anything that makes the process smoother should be welcomed by drug companies.
There are definite positives and negatives to the proposed system. But sponsors that are considering whether to join the pilot should consider this: FDA currently rejects almost half of proposed brand names—a percentage that has only increased in recent years. Any change to the process that might turn those numbers around is worth careful consideration—even if it means some bumps in the road along the way.