The FDA is performing fewer inspections on generic drug plants, which raises concerns over the safety and quality of generic medications on the market, according to an investigative report from Bloomberg.
Bloomberg spent a year investigating the FDA's regulation of the generic drug industry. Reporters examined more than 10 years of inspection data, along with thousands of pages of pretrial depositions. They also interviewed more than two dozen sources, including past and current FDA inspectors, agency officials, lawmakers and industry experts.
Five report findings:
1. The FDA approved a record 971 generics in fiscal year 2018, marking a 94 percent increase from fiscal year 2014, when 500 drugs were approved.
2. However, Bloomberg found FDA inspections of U.S. drug facilities have been decreasing since 2011, when the agency shifted more resources overseas. In 2018, the number of FDA inspections in the U.S. dropped 11 percent from the year prior.
3. International inspections have also been falling since 2016, which is important to note since drug companies in India and China account for nearly half of all new generic drugs. About 80 percent of active ingredients used to make drugs for Americans also come from outside the country.
4. When FDA inspectors do identify issues, the agency has sometimes been slow to respond, the report claims. In several cases, FDA inspectors discovered violations and started crafting enforcement letters before "higher-ups at the FDA … overrode the concerns of those on the ground," according to Bloomberg.
5. In a Jan. 30 tweet, FDA Commissioner Scott Gottlieb, MD, shared inspection data from fiscal years 2013-17, which "actually shows an increase in total domestic and foreign generic inspections," he said. In the Bloomberg report, Dr. Gottlieb noted the agency uses a formula that assesses risk factors, such as when a factory was last inspected, to decide which drug facilities to inspect.
"It's not the number of inspections we do, it's whether we're targeting effectively," he told Bloomberg.