Statement on the FDA's 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.

Today, we want 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.

Consumers must have confidence in the safety and quality of generic medicines. Generic drugs provide affordable access to critical treatments. They are just as safe and effective as their brand counterparts and we stand behind the regulatory efforts that go into ensuring the safety and quality of all generic drugs. Our rigorous standards and inspections apply equally to generic and brand drugs – whether the medicines are being manufactured in Shandong, India, or Indiana. 

We welcome discourse about our process through public comment and a constructive dialogue with all partners and stakeholders, including the press. We welcome the scrutiny of our programs. We welcome the accountability inspired by a free press. This dialogue is part of how we advance our public health mission. We also welcome here, the opportunity to lay out our case for our high confidence in our generic program.    

To address recent questions raised about the scope and effectiveness of our oversight of generic manufacturing, we've asked our teams of experts in pharmacovigilance, pharmaceutical quality, compliance, and enforcement to look into a few specific, critical observations that were made.

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