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# Gottlieb, Woodcock Reassure on Generic Drug Quality
- URL: https://www.fdaweb.com/gottlieb-woodcock-reassure-on-generic-drug-quality/
- Published: 2019-02-22T12:00:00.000Z
- Updated: 2026-09-15T01:06:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143450

FDA commissioner **Scott Gottlieb** and CDER director **Janet Woodcock** are defending the agency’s oversight of the generic drug industry to quash any doubt that generics are of lesser quality than branded drugs. In a 2/22 [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631838.htm?utm%5Fcampaign=022219%5FStatement%5FFDA%20statement%20on%20generic%20drug%20quality&utm%5Fmedium=email&utm%5Fsource=Eloqua), the FDA leaders take exception to recent media reports suggesting FDA has failed to conduct adequate post-marketing surveillance of generics.

On international inspections, Gottlieb and Woodcock note that the agency has been inspecting numerous drug manufacturing operations in China and India, while working closely with international regulatory partners in Europe to avoid duplication of inspections. “For instance, while surveillance inspections declined slightly in China from 2017-18, inspections in India have increased substantially,” they say. “Among other things, the number of inspections in any given country reflects our risk-based prioritization of our inspections and improvements in our targeting; our increasing ability to leverage inspectional work done by trusted partners, especially in Europe; and a higher number of pre-approval inspections.”

The officials outline several factors used to prioritize and schedule drug manufacturing inspections at higher risk facilities for quality-related surveillance. Factors include a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, and processing complexity, among others. “When you look at the full force of our inspectional resources, the FDA is maintaining global vigilance by concentrating inspections on higher risk facilities,” they say.

While inspection numbers have varied over the past few years, compliance actions, including Warning Letters, have increased steadily over the past four years, according to Gottlieb and Woodcock. In fact, they say, in FY 2018, CDER issued nearly five times as many Warning Letters to human drug manufacturers as it did in FY 2015 — 19 in FY 2015 vs. 94 in FY 2018.

The officials say that despite an increase in Warning Letters issued, “we don’t believe this reflects a growing problem in drug quality. On the contrary, the FDA’s improvements to targeting inspections and in evaluating recommendations for enforcement action mean more attention is being given to higher risk facilities than ever before. By better focusing our inspectional resources on higher risk facilities, we can identify potential quality problems that have the most impact on consumers. Then, we can take appropriate action to address our public health concerns.”

Overall, Gottlieb and Woodcock say agency inspection data show that most companies are in compliance with GMPs and other regulations. “While one publicly visible measure of FDA action, it’s important to understand that Warning Letters are not the FDA’s only course of action with a manufacturer following an inspection,” they write. “The FDA can also have regulatory meetings with companies; issue an untitled letter; conduct a follow-up inspection; and take other regulatory and compliance measures depending on the situation – and we often do much of this behind the scenes in the interest of patient safety, while also working to prevent potential drug shortages, for example.”