Statement from Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association on the Mutual v. Bartlett Supreme Court Ruling

PRESS RELEASE

WASHINGTON, DC (June 24, 2013) — “Today’s Supreme Court ruling on the Mutual v. Bartlett case upholds a key principle: decisions about the safety and efficacy of prescription drugs should rest with scientific experts at the Food and Drug Administration (FDA).

When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients. The experts at FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions.

The FDA’s job is to evaluate drugs on the science and make decisions that balance safety and risk with the need for access to life-saving medicines. Millions of patients rely on drugs like sulindac, which has been on the market for more than 30 years. It was prescribed and dispensed more than 300 million times between 2007-2012 with a typical safety profile. Decisions with this much at stake belong in the hands of the scientific, public health and regulatory experts at the FDA.