Waxman wants biologic drugs kept out of trade talks

A group of House Democrats urged President Obama on Thursday not to offer up U.S. policy on biologic drugs for inclusion in a trade agreement.

The healthcare reform law created an approval pathway for generic versions of biologic drugs, which are more complex than traditional pharmaceuticals. It gave brand-name biologics 12 years of protection from generic competitors.

Rep. Henry Waxman (D-Calif.) pushed hard for a shorter period. He and six other House Democrats said Thursday that the U.S. should not offer up its 12-year policy as negotiations over the Trans-Pacific Partnership (TPP). The U.S. is preparing to propose language on intellectual property for the agreement, and Waxman said biologics shouldn't be included.

In a letter to Obama, Waxman noted that the White House has proposed reducing the market protection to seven years.

"Were the TPP to ultimately contain a 12 year biologics exclusivity provision, it would impede the ability of Congress to achieve the Administration's proposed 7 year change without running afoul of U.S. trade obligations," the letter states. "We see no reason for the United States to agree to such a provision, much less propose it."