Biotech's new orphan deal
Also proposed: Market exclusivity for all 'biotechnology' drugs
By Kris Herbst
Contributing Editor

WASHINGTON - The biotechnology trade associations have drafted a "compromise" orphan drug bill that would reduce market exclusivity for orphan drugs to five years in exchange for termination of efforts in Congress to put a ceiling on orphan revenues.

The proposal also would create a new category of protection for all "biotechnology" drugs, providing four years of market exclusivity for any drug approved under the proposal's definition of a biotech drug, regardless of the size of the patient population.

According to an internal Industrial Biotechnology Association memo obtained by BioCentury, the boards of directors of the IBA and the Association of Biotechnology Companies are considering the proposed legislation drafted by an ABC/IBA orphan drug working group and amended by the ABC/IBA Issues Committee.

'Sales trigger'

"Each of the provisions discussed below is supported by a majority of the companies participating in the orphan drug working group and a larger majority of the companies participating on the Issues Committee," said the May 10 memo. "However, notwithstanding ten hours of meetings to discuss various approaches to amending the orphan drug law, it was not possible for the industry to come to a complete consensus. There was a virtual consensus, however, on the need to make a proposal to counter the Metzenbaum/Kassebaum/Waxman sales trigger approach."