(Bloomberg: by Anna Edney) The investigation by Bloomberg News into the generic-drug industry shows that FDA inspections at factories in West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.
In the face of such problems, the FDA approved a record 971 generic drugs in the fiscal year ending September 30, according to a report from the accounting firm PricewaterhouseCoopers. That was a 94 percent increase over fiscal year 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 year 2018 from fiscal 2017. Those inspections numbers also decreased in fiscal year 2017, falling 13 percent from the previous year, according to public records.
Surveillance inspections of just U.S. drug factories declined 11 percent, to 693 from fiscal year 2017 to fiscal year 2018, the data show. Such inspections have been falling since 2011, as the agency began focusing more on foreign manufacturers.
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. There is strong disagreement among agency veterans over what the recent declines in inspections means.
Industry proponents and the FDA say it decides which facilities to inspect using a risk score calculated by the agency. The also say the FDA can’t inspect its way to better-quality drugs, particularly with the limited resources it’s given, and that it’s up to drugmakers to police themselves.
West Virginia-based Mylan reports the FDA conducted 21 inspections at its almost 50 facilities around the world in 2018. The company sells more than 7,500 brand-name and generic drugs and over-the-counter treatments.
Today, 90 percent of the medications that Americans take are generics. They’re cheap because they rely on research done by brand-name pharmaceutical companies.