A: EVIDENCE SHOWS THAT MORE GENERIC COMPETITION leads to lower costs. One FDA analysis found that when there are three or more generics on the market, prices fall by more than half relative to having only one generic available. Thoughtful consideration of how to remove unnecessary regulatory barriers, as Commissioner Gottlieb has proposed, is an important step toward a more competitive generic marketplace.
But it is vital that any steps taken by the FDA to speed generic entry maintain the important patient safety safeguards that have made FDA approval the world’s “gold standard” for safety and efficacy. Poor first-cycle generic approval rates are one of the biggest barriers to speedier generic entry.
Tom is president, advocacy, law & public policy division for the Biotechnology Innovation Organization (BIO)