Statement by Ralph G. Neas, President and CEO, GPhA, Regarding 21st Century Cures Discussion Draft

January 27, 2015

"The Generic Pharmaceutical Association (GPhA) is deeply disappointed in today's 21st Century Cures discussion draft. While we appreciate that it is a draft, in its current form, the bill would upset the important balance between creating competition and encouraging innovation in the pharmaceutical marketplace, putting savings at risk and limiting access to affordable medicines for millions of American patients.

“The Generic Pharmaceutical Association (GPhA) is deeply disappointed in today’s 21st Century Cures discussion draft. While we appreciate that it is a draft, in its current form, the bill would upset the important balance between creating competition and encouraging innovation in the pharmaceutical marketplace, putting savings at risk and limiting access to affordable medicines for millions of American patients.

This balance has been vital to encouraging breakthroughs in medicine since the enactment of the 1984 Hatch-Waxman law. Yet, the Dormant Therapies provision of the bill would potentially grant brand drug companies an unprecedented increase in exclusivity for a curiously broad category of new drugs, delaying the competition from generic drugs and biosimilars that promotes beneficial innovations in treatments.

There are positive proposals in the draft released today that could improve health outcomes, and GPhA supports the goal of speeding the development of new cures. However, the overdependence on market exclusivity as an incentive for innovation threatens to turn back the clock more than 30 years—reversing the scientific advances and market access that have led to high rates of generic utilization and corresponding savings.

GPhA looks forward to working with Chairman Fred Upton to explore a more sensible, holistic approach to systemwide changes that encourage the development of new medicines. For example, the draft could address the misuse of FDA safety programs by some brand drug companies that thwarts competition from more affordable generic drugs. Together, we can identify a way forward that incentivizes innovation appropriately, doing more for the entire healthcare system than just providing a windfall of billions of dollars to brand manufacturers at the expense of patients and taxpayers.”

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.