Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad

Press Announcements > Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad

At the FDA, protecting patient and consumer health is our highest priority. Assessing and mitigating risks is at the heart of everything we do across our vast portfolio. Sometimes the actions we take are visible, like warning letters or recalls. At other times, our actions to protect consumers are less discernable, but equally vital. Analyzing and addressing potential risks is a complex effort based on data and grounded in science. These activities are at the center of our consumer protection mission and underpin our efforts to ensure the quality and safety of medical products.

Recently, there have been reports in the press calling into question the quality of our nation’s drug supply and specifically, asserting that certain generic drugs are of a lesser quality than brand drugs. Some of these reports claim to be based on data analysis. We believe these interpretations are seriously flawed and do not account for the full picture of our global vigilance over generic drug manufacturing.

FDA wants to explain some of the fundamental steps we take to protect the quality and effectiveness of generic medicines that consumers and patients rely on every day and address what we believe are shortcomings in the analyses that have been performed by some news outlets. We recognize that our statement, in part directly responding to a news report, is not customary; we nonetheless feel obligated to provide a substantive response given the public health issues at stake.

Read on in the  Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad.