WAXMAN PLANS TO INTRODUCE BIPARTISAN BIOGENERICS BILL

Rep. Henry Waxman (D-Calif.) plans to introduce a bipartisan bill later this year that would establish a regulatory pathway for generic biologics.

When biologic patents expire, we ought to allow generics to enter the market to provide competition, he said recently at the annual meeting of the Generic Pharmaceutical Association (GPhA). But Waxman also noted that each biologic should be considered on a case-by-case basis.

Waxman and fellow generic drug advocate Sen. Orrin Hatch (R-Utah) recently sent a letter to acting FDA Commissioner Andrew von Eschenbach asking him to allow the approval of generic versions of insulin and human growth hormone.

In his speech before GPhA, Waxman also expressed concerns about how consumers are reacting to direct-to-consumer ads. The ads are causing consumers to ask doctors for the advertised drugs even if the drugs are not right for them, he said.

In addition, Waxman noted that the FDA had been "leaderless" for years, and concluded that the agency needs a permanent head who will make decisions based on "the best scientific evidence." As far as the current FDA is concerned, science "is just another political opinion," Waxman said. "We must make sure that the FDA itself does not become a roadblock to access to generic drugs."