FDA Sees Hike in Combination Product Applications

The US Food and Drug Administration (Rockville, MD, www.fda.gov) saw a 10% boost in the number of applications for combination products this year, according to the Dec. 28 edition of Drug Industry Daily (DID).

FDA identifies a combination product as “a product comprised of two or more regulated components, i.e., drug–device, biologic–device, drug–biologic, or drug–device–biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.” A drug also is considered a combination product if it is packaged with another drug or meant to be used with another drug,

“As industry has told us for some time, this is an area that they’re increasingly looking to in terms of increasing their product portfolios,” Mark Kramer, director of the Office of Combination Products (OCP) told DID. “And I think the numbers are bearing it out.” Kramer expects the number of submissions for combination products to increase again in 2006. “We get more and more inquiries all the time,” he said. “I believe it is a trend that is here to stay.”

DID

noted that the while there is a spike in the amount of combination drug approvals, the general drug pipeline is still quite low compared with 10 years ago. "FDA approved 53 new drugs in 1996, but may approve roughly 17 this year.”