Posted by Michael Wonder on 22 Feb 2019
Statement from FDA Commissioner and Director of FDA’s Center for Drug Evaluation and Research on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
22 February 2019 - 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 discernible, but equally vital. Analysing and addressing potential risks is a complex effort based on data and grounded in science. These activities are at the centre 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.
