FDA to Discuss Combination Product Cross-Labeling

The FDA is seeking advice on whether it should consider reviewing -- and possibly approving or clearing -- a new product labeled for use in conjunction with an already approved product of a different type.

To that end, the FDA will hold a meeting May 10, in cooperation with the Drug Information Association, to discuss such issues. The meeting is being held to solicit stakeholders' views and perspectives about the legal and public health issues that arise when sponsors seek to develop or market a device, drug or biological product that would be labeled for use with an already approved product of a different type for instances in which the approved product's labeling would not be changed.

Often, two companies will work together to bring each product to market with mutually conforming labeling, sharing the responsibility to resolve scientific or legal issues that may arise as a result of the products coming from two independent companies. The sponsor of the approved product ordinarily must submit a supplement to its marketing application to amend the currently approved labeling to include directions for using the two products together.

However, there are instances when two companies do not work together. The sponsor of the approved product may end up refusing to submit a supplement to allow a new product to be created. In such cases, requiring that the two products have mutually conforming labeling could end up preventing the development of new products.

The FDA is concerned that valuable products may not be developed, manufactured or distributed because of sponsor concerns about mutually conforming labeling. A copy of the meeting's program and registration information is available online at http://www.diahome.org/Content/Events/05028.pdf (http://www.diahome.org/Content/Events/05028.pdf).