Competition should always drive costs down—never quality. The FDA should withdraw this misguided guidance before it harms vulnerable infants and undermines the trust that makes our generic system work.
America’s generic drug market is one of our greatest health policy successes. Today, 91% of all prescriptions in the U.S. are filled with generics. That dominance saves patients and taxpayers hundreds of billions of dollars every year—and it also drives innovation. Drugmakers know their monopoly on a new treatment will be temporary—typically only enjoying about 12-14 years of effective market exclusivity—which pushes them to keep inventing rather than coasting on old pharmaceuticals.
This success rests on a simple but powerful principle: generics can compete on price, but never by sacrificing quality or safety. Patients and doctors trust generics because they are required to be clinically equivalent to their branded counterparts—matching on active ingredient, dosage, route of administration, therapeutic effect, and safety. The Hatch-Waxman Act of 1984 enshrined that principle, striking a balance that has made the U.S. generic market the strongest in the world—and the most affordable.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.
Generics Must Compete On Price, Not Safety
Sally C. Pipes
Competition should always drive costs down—never quality. The FDA should withdraw this misguided guidance before it harms vulnerable infants and undermines the trust that makes our generic system work.
America’s generic drug market is one of our greatest health policy successes. Today, 91% of all prescriptions in the U.S. are filled with generics. That dominance saves patients and taxpayers hundreds of billions of dollars every year—and it also drives innovation. Drugmakers know their monopoly on a new treatment will be temporary—typically only enjoying about 12-14 years of effective market exclusivity—which pushes them to keep inventing rather than coasting on old pharmaceuticals.
This success rests on a simple but powerful principle: generics can compete on price, but never by sacrificing quality or safety. Patients and doctors trust generics because they are required to be clinically equivalent to their branded counterparts—matching on active ingredient, dosage, route of administration, therapeutic effect, and safety. The Hatch-Waxman Act of 1984 enshrined that principle, striking a balance that has made the U.S. generic market the strongest in the world—and the most affordable.
Now, the FDA is putting that trust at risk.
Read the entire op-ed here.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.