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For decades, the Food and Drug Administration quietly allowed substandard foreign factories to continue transporting to the United States, even after government agencies officially banned them due to dangerous manufacturing failures.
Propublica exposed a lesser-known practice in June. The FDA said the decision to exempt certain drugs from the import ban was made to avoid drug shortages, and the guardrail was installed to ensure that the products are safe, including requiring banned factories to perform additional testing of the drug before they are sent to Americans.
However, the agency itself has regularly tested the drug, actively monitored reports submitted by doctors and other doctors, and introduced consumers who have experienced foul odors, unusual tastes or residues, or sudden health issues. The FDA warns that the outcomes mentioned in the complaint may be unrelated to the drug or may be unexpected side effects. But drug safety experts say it’s impossible to know if people were harmed, how many and how many, without further research.
The FDA has kept the exemptions hidden for the public for the majority and has never published a comprehensive list of permitted US from banned factories. Propublica is publishing its list today.
This list provides the names of the drug or ingredient that ProPublica has identified as being exempt from the import ban since 2013, as well as the manufacturer’s name. The product name is written when it appears in the FDA import alert list. Most of the factories on this list are no longer banned, so their medicines come to the country through regular channels. The FDA lifts the ban when the facility makes all necessary modifications.
Some factories are still prohibited, but are allowed to send exempt drugs to the United States.
Drugs exempted since 2013
ProPublica has identified more than 150 exempted products from factories, primarily in India. One factory in China and one factory in Hungary were also exempted. Some factories produce the ingredients of the drug, then sent to the manufacturer that produces pills, capsules, tablets, or injections.
To compile a list of exempt drugs and ingredients, reporters pulled historical records from the internet and used Redica Systems. RedicaSystems is a quality and regulatory information company with a vast collection of institutional documents.
When completing the analysis, Propublica counted all drugs and ingredients exempted from each prohibited factory. Sometimes the same product was exempt from multiple factories and added to the total of each factories. In only a handful, the FDA exempted several formulations, including tablets, capsules, or injectables of the same drug. Propublica counted these different forms as distinct drugs.
On this list, Propublica only contained each drug once in each manufacturer.
The giant Indian drugmaker could not fix the safety breach. The FDA has been off the hook again and again.
There may be many manufacturers of generic drugs, and it is difficult to know based on the information provided on the drug from which the drug was made or the bottle of medicine provided by whom. The bottle may list the names of the reattacker or distributors, not the drugmaker itself. Pharmacists and possibly health care providers can provide additional information about the source of the medication that was prescribed.
This list is up to date as of August 4th. The FDA may add or remove exempt drugs at any time.
Company Answers
Propublica has contacted all drug makers listed here. Most of them didn’t respond.
Apotex did not respond to requests for comment. After the inspection that led to an import ban, the company told the FDA it would launch corrective action and trigger third-party consultants and others. Factory is no longer banned.
Divi’s lab did not respond to requests for comment. In response to the FDA at the time, the company said it had hired third-party consultants and other experts to resolve FDA concerns. The company also said it has taken corrective action at the facility. Factory is no longer banned.
Emcure Pharmaceuticals did not respond to requests for comment. In response to the FDA at the time, the company said it would modify procedures, provide training and engage consultants, among other things. Factory is still prohibited, but there are no exemptions anymore.
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 concerns. The factory is still prohibited, but is not exempted.
GPT Pharmaceuticals did not respond to requests for comment. In response to the FDA, the company said it defended the quality of its products and attracted consultants to audit its business. Factory is no longer banned.
In a statement to ProPublica, Pfizer, which owns Hospira, submitted a comprehensive response to the FDA, suspending production at the site and sold the facility to another company in 2019. Factory is no longer banned.
Intas Pharmaceuticals, a US subsidiary, said in a statement that the company has invested in multi-million dollar upgrades and new recruits and launched a company-wide program focusing on quality. The exempt drug was sent to the US in a “stage-based way,” the company said, with third-party monitoring and safety testing. Intas also said that some exempt drugs will not be shipped to the US as the FDA has found other suppliers. The company does not provide details. “Intas is on track to complete restoration of all manufacturing sites,” the company said. The two Intas factories are still banned and still exempted.
The IPCA Institute did not respond to requests for comment. At the time, the IPCA said it was working to solve the problem at several factories. “The company is committed to the highest quality philosophy in manufacturing, operations, systems, integrity and CGMP culture,” IPCA said, referring to the industry’s popular phrase, “currently good manufacturing practices.” Factory is no longer banned.
Jubilant Generics did not respond to requests for comment. At the time, the company said it would “interact with agents to resolve import alerts at the earliest time and ensure CGMP compliance.” 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 was planning to resolve FDA concerns. “We are committed to maintaining maximum quality and compliance and maintaining CGMP and quality standards at all Shilpa facilities.” The factory is still banned and one of its medicines is still exempt.
Sri Krishna Pharmaceuticals did not respond to requests for comment. At the time, the company told the FDA it used consultants to audit its operations and help meet manufacturing requirements. Factory is still prohibited, but no longer has exemptions.
In a statement to Propublica, Sun Pharma said that compliance with quality standards is “a top priority for the Sun and focuses on tolerance in quality and compliance to ensure an uninterrupted supply of medicines to customers and patients around the world. The factory is still banned and exempted.
Teva Pharmaceuticals did not respond to requests for comment. In a statement at the time, the company said it was working to avoid drug shortages “while focusing on resolving regulatory concerns, as patients are always top priority.” Factory is still prohibited, but no longer has exemptions.
Wockhardt did not respond to requests for comment. According to Reuters, during a conference call with reporters at the time of the import ban, Wockhardt said the company is “making all sorts of efforts to satisfy” the FDA’s excellent manufacturing standards at its factories. The factory is still banned, but in July Wokhart announced it would no longer make generics for the US market.
Zhejiang Hisun Pharmaceutical did not respond to requests for comment. According to a Bloomberg report, Heesun took quality seriously at the time and said he was following the requirements. Factory is no longer banned.
In a statement to ProPublica, Mylan/Viatris said it worked quickly to resolve FDA concerns. “Patient safety remains a major and unwavering focus,” the company said. The factory is still banned and exempted.
A lawyer for Madhu Instruments told Propublica in an email that the company has fixed all issues identified by the FDA and is fully cooperating. Factory is still prohibited, but there are no exemptions anymore.
Brandon Roberts and Irena Fan provided the data report.
