The New York Times reports today that the leaders of Congress are crafting a compromise bill that will open the pathway for generic versions of biological drugs. Biological drugs, the fastest growing and most expensive segment of the pharmacetical market, were not even on the radar screen when Congress passed the Hatch-Waxman Act in 1984. That Act gave birth to the thriving generic drug industry.
Generic drugs are chemically identical to their branded counterparts, and no additional human testing is required to market them. The only prerequisite is patent expiration for the branded drug. The biotechnology industry claims that the complexities of biological drugs necessitates human testing of generic versions. The Times reports that
“Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original.”
Dr. Woodcock gave this testimony at a hearing held on March 26, 2006 before the House Oversight and Government Reform Committee. Stay tuned.