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

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.

The list provides the names of the drugs or ingredients that ProPublica has identified as having been exempted from an import ban since 2013 and the names of the manufacturers that made them. The product names are written as they appeared on the FDA’s import alert list. Most of the factories on this list are no longer banned, so their drugs are coming into the country through normal channels. The FDA lifts bans after facilities make all the necessary fixes.

Some of the factories are still banned — and are still allowed to send exempted drugs to the U.S. Those are highlighted in yellow.

All told, ProPublica identified more than 150 exempted products, mostly from factories in India. One factory in China and one factory in Hungary also received exemptions. Several of the factories make ingredients for drugs, which are then sent to the manufacturers that produce pills, capsules, tablets or injectables.

To compile the list of exempted drugs and ingredients, reporters pulled historical records from the internet and used Redica Systems, a quality and regulatory intelligence company with a vast collection of agency documents.

In finalizing its analysis, ProPublica counted all the drugs and ingredients that were exempted from each banned factory. Sometimes, the same product was exempted from multiple factories and was added to each factory’s total. In a handful of cases, the FDA exempted several formulations — such as a tablet, capsule or injectable — of the same drug. ProPublica counted those different forms as distinct drugs.

For this list, ProPublica only included each drug once for each manufacturer.

Generic drugs can have many manufacturers, and it can be difficult to know based on information provided on medicine bottles where drugs were made or by whom. Sometimes bottles list the names of repackagers or distributors rather than the drugmaker itself. Pharmacists and possibly health care providers can provide additional information about the source of prescribed medications.

This list is current as of Aug. 4. The FDA can add or remove exempted drugs at any time.

Company Responses

ProPublica reached out to all the drugmakers listed here. Most did not respond.

Apotex did not respond to requests for comment. After the inspections that led to the import bans, the company told the FDA that it would launch corrective actions and bring on a third-party consultant, among other things. The factories are no longer banned.

Divi’s Laboratories did not respond to requests for comment. In its response to the FDA at the time, the company said it hired third-party consultants and other experts to resolve the FDA’s concerns. The company also said it had taken corrective actions at the facility. The factory is no longer banned.

Emcure Pharmaceuticals did not respond to requests for comment. In its response to the FDA at the time, the company said it would revise procedures, provide training and engage consultants, among other things. The factory is still banned but no longer has exemptions.

Glenmark Pharmaceuticals did not respond to requests for comment. At the time of the ban, the company said it would engage with the FDA to resolve the concerns. The factory is still banned but is no longer receiving any exemptions.

GPT Pharmaceuticals did not respond to requests for comment. In its response to the FDA, the company defended the quality of its products and said it had brought on a consultant to audit the operation. The factory is no longer banned.

In a statement to ProPublica, Pfizer, which owns Hospira, said it submitted a comprehensive response to the FDA, paused production at the site and then sold the facility to another company in 2019. “We are committed to operating our manufacturing sites at the highest quality standards,” Pfizer said. The factory is no longer banned.

Intas Pharmaceuticals, whose U.S. subsidiary is Accord Healthcare, said in a statement that the company has invested millions of dollars in upgrades and new hires and launched a companywide program focused on quality. Exempted drugs were sent to the United States in a “phased manner,” the company said, with third-party oversight and safety testing. Intas also said that some exempted drugs were never shipped to the United States because the FDA found other suppliers. The company would not provide details. “Intas is well on its way towards full remediation of all manufacturing sites,” the company said. The two Intas factories are still banned and still receiving exemptions.

Ipca Laboratories did not respond to requests for comment. At the time, Ipca said it was working to resolve the issues at several factories. “The company is committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture,” Ipca said, referring to “current good manufacturing practices,” a common phrase in the industry. The factories are no longer banned.

Jubilant Generics did not respond to requests for comment. At the time, the company said it would “engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.” The factory is no longer banned.

Shilpa Medicare did not respond to requests for comment. In a media statement at the time, the company said it planned to resolve the FDA’s concerns. “We uphold quality and compliance with utmost importance and are committed to maintaining cGMP and quality standards across all Shilpa facilities.” The factory is still banned and one of its medications is still exempt.

Sri Krishna Pharmaceuticals did not respond to requests for comment. The company at the time told the FDA that it was using a consultant to audit operations and assist in meeting manufacturing requirements. The factory is still banned but is no longer receiving exemptions.

In a statement to ProPublica, Sun Pharma said that adherence to quality standards “is a top priority for Sun, and we maintain a relentless focus on quality and compliance to ensure the uninterrupted supply of medicines to our customers and patients worldwide. We continue to work proactively with the US FDA and remain committed to achieve full resolution of any FDA regulatory issues at our facilities.” The factory is still banned and still receiving exemptions.

Teva Pharmaceuticals did not respond to requests for comment. The company said in a statement at the time that it was working to avoid drug shortages “while we focus on resolving regulatory concerns, as patients are always highest priority.” The factory is still banned but no longer receiving exemptions.

Wockhardt did not respond to requests for comment. In a conference call with reporters at the time of the import ban, according to Reuters, the Wockhardt chairman said the company was “making all kinds of effort to satisfy” FDA good manufacturing standards at the factory. The factories are still banned, but in July, Wockhardt announced that it would no longer make generics for the U.S. market.

Zhejiang Hisun Pharmaceutical did not respond to requests for comment. According to a report in Bloomberg, Hisun said at the time that it takes quality seriously and has complied with requirements. The factory is no longer banned.

Mylan/Viatris said in a statement to ProPublica that it immediately worked to resolve the FDA’s concerns. “Patient safety remains our primary and unwavering focus,” the company said. The factory is still banned and still receiving exemptions.

A lawyer for Madhu Instruments told ProPublica in an email that the company has fixed all the problems identified by the FDA and is cooperating fully. The factory is still banned but no longer has an exemption.