PHARMACY

AAM to Congress: Reject 2019 Hatch-Waxman bill

BY Sandra Levy

The Association for Accessible Medicines voiced strong opposition to the Hatch-Waxman Integrity Act in a letter urging Congress to reject “this misguided legislation.”

In a letter to Sens. Lamar Alexander, R-Tenn, and Patty Murray, D-Wash., as well as Reps. Frank Pallone, D-N.J. and Greg Walden, R-Ore., AAM president and CEO Chip Davis said, “AAM strongly opposes the Hatch-Waxman Integrity Act of 2019 (S. 344/H.R. 990). The Hatch-Waxman Integrity Act, if enacted, would make it harder for generic and biosimilar drugs to bring price competition to patients seeking relief from skyrocketing brand name prescription drug prices. The legislation would weaken the quality of the patent system, limit the Constitutional rights of generic and biosimilar manufacturers, and provide special treatment to brand name pharmaceutical companies allowing them to charge patients higher drug prices for longer.”

Davis continued, “Instead of considering such legislation that would decrease patient access to generic and biosimilar medicines, we strongly encourage Congress to advance policies that increase patient access to more affordable, FDA approved generics and biosimilars and take meaningful action to lower prescription drug costs. AAM would be happy to work with you to advance legislation to eliminate pharmaceutical gamesmanship of the patent system and to preserve true innovation.”

Davis went on to state that innovative drug companies are strongly incentivized to develop new therapies. “This is a critical piece of both the Drug Price Competition and Patent Term Restoration Act, commonly called Hatch-Waxman (P.L. 98-417) and the Biologics Price Competition and Innovation Act, or BPCIA (P.L. 115-52). In exchange for developing new and life-saving therapies, brand pharmaceutical companies are compensated in the form of generous patent rights and additional exclusivities.”

“But these incentives are only a piece of these landmark laws. Balancing the need for innovation, Hatch-Waxman and BPCIA also seek to ensure that patients will have access to more affordable versions of these medicines as soon as patents and exclusivities expire. When government-granted monopolies expire, competition — driven by the entrance of generic and biosimilar versions of these medicines — brings down the price of expensive brand-name drugs and ensures greater patient access to them. That balance, however, is in jeopardy. The Hatch-Waxman Integrity Act would imperil it even further,” Davis said.

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