FDA Defends its Efforts to Ensure Generic Drug Quality

Regulatory NewsRegulatory News | 22 February 2019 |  By 

The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs.

FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wrongfully asserted that certain generic drugs are of a lesser quality than brand name drugs.

“We believe these interpretations are seriously flawed and do not account for the full picture of our global vigilance over generic drug manufacturing,” Gottlieb and Woodcock said.

The statements, while not explicitly targeting any single news article, appear directed at a recent Bloomberg investigation (other parts here and here) and Kaiser Health News story explaining how data integrity and other manufacturing issues have led to recalls and quality concerns, particularly in India and China, but also in the US. However, the articles also note the difficulties proving that certain medicines were ineffective because of manufacturing issues.

And in response to particulars in the press reports, FDA said it “has no concerns regarding the safety or efficacy of any generic atorvastatin at this time, including the Mylan product which was cited.”

Bloomberg, meanwhile, points out that global surveillance inspections by FDA dropped 11% in fiscal 2018 from fiscal 2017, while surveillance inspections of foreign factories fell 10% over the same time period. But an FDA spokesperson countered to Focus that surveillance inspections do not include pre-approval inspections so they do not tell the full story. And if one looks at the pre-approval and the surveillance inspections, then the numbers are increasing.

“While the numbers of inspections have varied over the past few years, compliance actions, including warning letters, have increased,” Gottlieb and Woodcock added. “In fact, in FY 2018, CDER issued nearly five times as many warning letters to human drug manufacturers as it did in FY 2015.”

And at least part of the reason inspections appear to be going down is that the agency can now rely on its European counterparts to conduct certain inspections.

But the increase in warning letters and compliance actions does not reflect a growing problem in drug quality, FDA adds.

“On the contrary, 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,” Gottlieb and Woodcock wrote.

They also explain how FDA labs tested 323 products from around the world – including more than 100 from India – to determine if foreign manufacturers had a higher incidence of product failure.

“All 323 samples met US market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications,” they said. “Overall, our inspections find that most companies are in compliance with good manufacturing practices and other regulations.”



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