US generic drug firms seek biologics trade

11 February 1998 23:20  [Source: ICIS news]

WASHINGTON (CNI)--Three trade associations representing the generic drugs industry Wednesday appealed to the US Senate not to bar generic versions of biological products.

In a letter to Senate Labor and Human Resources Committee Chairman James Jeffords, Republican-Vermont, the trade groups warn that a technical bill working its way through the Senate may inadvertently impede development of generic biological products.

House Concurrent Resolution 196, which both the House and Senate are likely to consider this year, includes several corrections of technical and drafting mistakes that were made in the Food and Drug Modernization Act that Congress passed last year.

According to the generic trade groups, CR 196 also includes a provision prohibiting the Food and Drug Administration (FDA) from approving generic versions of biological products.

The Generic Pharmaceutical Industry Association, National Association of Pharmaceutical Manufacturers, and the National Pharmaceutical Alliance contend that the biological provision in CR 196 is a substantive policy decision that should not be addressed as an incidental matter in a corrections bill.

The generics trade associations want to prevent Congress from closing the door on generic biologics without full consideration of the consequences.

The FDA does not allow generic competition for biologics and certain biotechnology-derived drug products. However, the agency is considering whether it should revise the policy.

Generic manufacturers told Jeffords they are afraid Congress may accidentally block a door that FDA may be about to open.

But trade groups representing brand-name pharmaceutical manufacturers - including The Pharmaceutical Research and Manufacturers of American and the Biotechnology Industry Organization - support CR 196 and oppose the establishment of a new class of generic biologicals.

By: Steve Usdin
+1 713 525 2653

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