FDA Generic Drug Inspections, Enforcement Down: Bloomberg News
A year-long Bloomberg News inspection finds that FDA generic drug manufacturer inspections and enforcement actions have declined, even as approvals of generic drugs have increased in an effort to drive down drug prices through increased competition. The news service says that while concerns about quality control and data integrity have focused on companies in India and China, its interviews and document reviews “suggest that these concerns aren’t limited to overseas factories. And the issues surrounding them are two-fold: a drop-off in inspections in many places and, in some cases, the softening of penalties when problems are found.”
The report looks at a 2016 inspection of Mylan’s Morgantown, WV, manufacturing facility in which inspectors found bins full of shredded documents, including quality control records, in parts of the factory where every piece of paper is supposed to be saved.
“The list of alleged infractions became so long that a fourth inspector was added,” Bloomberg reports. “A Warning Letter, FDA’s strongest rebuke, was drafted. It would mean the agency could refuse to consider any Mylan applications for a new drug made at that plant until the company fixed things. But the Warning Letter was never sent. Eight months later in 7/2017, higher-ups at FDA apparently decided to take it easy on Mylan…. FDA ultimately left it in the company’s hands, and the drugmaker promised to address what the agency calls a ‘data integrity’ issue. FDA didn’t say specifically why it chose not to warn the company.” Mylan told Bloomberg it demonstrated to the agency that the testing in question “occurred in the development environment and was not associated with commercial product.”
The report also discusses the court battle between Fresenius and Akorn over quality control failures at Akorn, during which a consultant for Akorn testified that quality control issues are not unique to any one company but are something “that the entire industry is struggling with.”
Bloomberg says that while FDA approved a record 971 generic drugs in the fiscal year that ended last 9/30, a 94% increase over FY 2014, the number of surveillance inspections globally dropped 11% from FY 2017 to FY 2018. And they had already dropped 13% from FY 2016 to FY 2017.
“Surveillance inspections of just U.S. drug factories declined 11%, to 693, from FY 2017 to FY 2018, the lowest going back for at least a decade,” the report says. Such inspections have been falling since 2011, as the agency focused more on foreign manufacturers. However, from FY 2017 to FY 2018, surveillance inspections of foreign factories fell 10% to 778. This was the second year-over-year decline, after surveillance inspections of foreign factories dropped 9% from FY 2016 to FY 2017, reversing a trend of rising inspections over most of the previous decade.” The report says one marked exception to the drop in inspections was India, where they increased 18% in FY 2018.
FDA commissioner Scott Gottlieb and others told the news service that the numbers reflect a smarter, more surgical approach to inspections. “It’s not the number of inspections we do, it’s whether we’re targeting effectively,” he said.
Bloomberg airs concerns raised by former FDA commissioner Margaret Hamburg and members of Congress.
“I think our oversight is better than it’s ever been,” said CDER director Janet Woodcock. “That’s my professional judgment of manufacturing worldwide. We know where they are, we know who they are, we know what they’re making, we know when we’ve been there, we know who else has been there. Could we improve? Yes, but I wouldn’t look at absolute stark numbers and say that should be a greater or lesser cause for concern.” She pointed to the agreement with European Union counterparts as one reason that surveillance inspections by FDA staff could be going down. But, Bloomberg notes, the agreement took effect only in 11/2017, after the surveillance numbers started falling, and it doesn’t cover India or China.
“Democratic and Republican lawmakers alike worry FDA may be backsliding on quality control just as it’s approving more generics,” the report concludes.