Concerns about quality control and data integrity have focused on numerous companies in India and China, where more and more drugs and active ingredients used in medicine for the U.S. are being made. But the interviews and documents suggest that those concerns aren’t limited to overseas factories. And the issues surrounding them are twofold: a drop-off in inspections in many places and, in some cases, the softening of penalties when problems are found.
Failures of quality control have also become a matter of dispute between generic-drug companies. Last month, the Delaware Supreme Court permitted the German company Fresenius SE to back out of its $4.3 billion takeover of Lake Forest, Illinois-based Akorn Inc. after Fresenius learned of a longstanding pattern of such problems in Akorn’s drug development and manufacturing systems.
The High Cost of Cheap Pills
A yearlong investigation by Bloomberg News into the generic-drug industry shows FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective. This is the first of four parts.
In a taped deposition for the case, a pharmaceutical consultant testifying for Akorn said its issues are commonplace. “It is not unique to any one company,” said George Toscano, a data integrity expert at consulting firm NSF International who has done hundreds of drug-manufacturing audits. “It’s something that the entire industry is struggling with.”
In the face of such problems, the FDA approved a record 971 generic drugs in the fiscal year ending Sept. 30, according to a report from the accounting firm PricewaterhouseCoopers. That was a 94 percent increase over fiscal 2014, when 500 were approved.
Yet the number of so-called surveillance inspections done globally by the FDA—meant to ensure existing drug-making plants meet U.S. standards—dropped 11 percent, to 1,471, in fiscal 2018 from fiscal 2017. Those inspection numbers also decreased in fiscal 2017, which included Gottlieb’s first few months in office, falling 13 percent from the prior year. The figures were obtained through a public-records request.
Surveillance inspections of just U.S. drug factories declined 11 percent, to 693, from fiscal 2017 to fiscal 2018, the lowest going back for at least a decade, the data show. Such inspections have been falling since 2011, as the agency began focusing more on foreign manufacturers.
Meanwhile, from fiscal 2017 to fiscal 2018, surveillance inspections of foreign factories fell 10 percent, to 778. This was the second year-over-year decline, after surveillance inspections of foreign factories dropped 9 percent from fiscal 2016 to fiscal 2017, reversing a trend of rising inspections over most of the previous decade. One marked exception to the recent drops: India, where inspections jumped 18 percent in fiscal 2018.
While inspections alone don’t ensure the safety of America’s drug supply, they are one of the few concrete measures available to assess FDA’s oversight. Even among agency veterans, there is strong disagreement over what the recent declines in inspections means.