The FDA Let Substandard Factories Ship These Medications to the U.S. for 12 years

For more than a dozen years, the Food and Drug Administration quietly allowed substandard foreign factories to continue shipping medications to the United States even after the agency officially banned them from doing so because of dangerous manufacturing failures.

ProPublica exposed the little-known practice in June. The FDA said the decisions to exempt certain medications from import bans were made to fend off drug shortages and that guardrails were in place to ensure the products were safe, such as requiring the banned factories to do extra testing on the drugs before they were sent to Americans.

But the agency itself didn’t regularly test the drugs or proactively monitor reports filed by doctors and others that described drugs with a foul odor, abnormal taste or residue, or consumers who had experienced sudden or unexplained health problems. The FDA cautions the outcomes described in the complaints may have no connection to the drugs or could be unexpected side effects. But drug safety experts say that without further study, it’s impossible to know whether people were harmed or how many.

The FDA kept the exemptions largely hidden from the public and has never released a comprehensive list of the drugs allowed into the United States from banned factories. ProPublica is publishing that list today.