LAWMAKERS ANTICIPATE BIOGENERIC BILL APPROVAL THIS YEAR

The authors of the legislation that paved the way for improved market access for generic drug firms are confident that legislation to facilitate biogeneric entry is likely to move forward before the end of 2007.

Sen. Orrin Hatch (R-Utah) told attendees at the Generic Pharmaceutical Association's annual conference last week that many members of Congress have expressed interest in S.623, the "Access to Life-Saving Medicine Act," adding that it can passed.

Rep. Henry Waxman (D-Calif.) said he believes the generic industry is in a better position due to the shift in political climate that gave Democrats control of Congress. He said newly introduced legislation, such as the biogeneric and reverse-payment bills, address "some of the many roadblocks brand companies have put in the way of generic firms."

Biologic drugs were not covered under the original provisions of the Hatch-Waxman act, the congressman pointed out, adding that, as a result, the FDA has no comprehensible method for approving these drugs. Until the agency has the authority to approve them, consumers, employers and others will have to pay extraordinary costs for these drugs, he said.

Waxman was critical of brand drug companies' efforts to "spread misinformation about biogenerics. Seeing this legislation enacted will be one of my highest priorities in Congress," he said.

A major concern for Waxman is the wide-ranging power and influence he said the PhRMA and the Biotechnology Industry Organization (BIO) have throughout the business community.

He said PhRMA and BIO have access to a lot of members, many of whom are in the medical and insurance industries.

( http://www.fdanews.com/did/6_45/ )