FDA Should Act on Follow-On Biologics, Waxman Says

Although Rep. Henry Waxman (D-Calif.) continues to support the Hatch-Waxman Act, he acknowledged recently that the law is not a complete solution to the problems generic drugmakers face in trying to bring new products to market, particularly generic biologic products.

"The early days [before Hatch-Waxman] were an interesting time because pharmaceutical companies had the ability to develop lots of drugs, but didn't have the ability to get generics on the market," Waxman said at the Generic Pharmaceutical Association's annual meeting in Boca Raton, Fla. "It was a great move forward when we established that legislation. I take great pride in it, and in the success it's had in promoting competition, which has allowed us to lower prices. Since Hatch-Waxman, the generics' share of the market has grown significantly, [but] the law fell short of a full solution to the problem."

One of the outstanding issues, Waxman said, is the issue of follow-on biologics, which still don't have a formal approval pathway. Waxman acknowledged that when he co-authored Hatch-Waxman in 1984, he didn't anticipate the problem.

"Once [brand] patents have expired, consumers should have access to affordable medicines," Waxman said. "Permanent monopolies by brands are not wise," he continued. "The time has come to approve a system for approving biogenerics, [but] we must get the science right, because if the science isn't sound, the brand industry will destroy the image of [these generic products] in the eyes of consumers and physicians."