For greater than a dozen years, the Meals and Drug Administration quietly allowed substandard overseas factories to proceed transport drugs to the USA even after the company formally banned them from doing so due to harmful manufacturing failures.
ProPublica exposed the little-known practice in June. The FDA mentioned the selections to exempt sure drugs from import bans have been made to fend off drug shortages and that guardrails have been in place to make sure the merchandise have been secure, comparable to requiring the banned factories to do further testing on the medication earlier than they have been despatched to Individuals.
However the company itself didn’t usually check the medication or proactively monitor studies filed by medical doctors and others that described medication with a foul odor, irregular style or residue, or customers who had skilled sudden or unexplained well being issues. The FDA cautions the outcomes described within the complaints could don’t have any connection to the medication or may very well be surprising uncomfortable side effects. However drug security specialists say that with out additional examine, it’s unimaginable to know whether or not individuals have been harmed or what number of.
The FDA stored the exemptions largely hidden from the general public and has by no means launched a complete listing of the medication allowed into the USA from banned factories. ProPublica is publishing that listing right now.
The listing supplies the names of the medication or components that ProPublica has recognized as having been exempted from an import ban since 2013 and the names of the producers that made them. The product names are written as they appeared on the FDA’s import alert listing. A lot of the factories on this listing are not banned, so their medication are coming into the nation by regular channels. The FDA lifts bans after amenities make all the required fixes.
Among the factories are nonetheless banned — and are nonetheless allowed to ship exempted medication to the U.S. These are highlighted in yellow.
All informed, ProPublica recognized greater than 150 exempted merchandise, largely from factories in India. One manufacturing facility in China and one manufacturing facility in Hungary additionally acquired exemptions. A number of of the factories make components for medication, that are then despatched to the producers that produce drugs, capsules, tablets or injectables.
To compile the listing of exempted medication and components, reporters pulled historic information from the web and used Redica Systems, a high quality and regulatory intelligence firm with an unlimited assortment of company paperwork.
In finalizing its evaluation, ProPublica counted all of the medication and components that have been exempted from every banned manufacturing facility. Generally, the identical product was exempted from a number of factories and was added to every manufacturing facility’s complete. In a handful of circumstances, the FDA exempted a number of formulations — comparable to a pill, capsule or injectable — of the identical drug. ProPublica counted these totally different types as distinct medication.
For this listing, ProPublica solely included every drug as soon as for every producer.
Generic medication can have many producers, and it may be tough to know primarily based on data supplied on drugs bottles the place medication have been made or by whom. Generally bottles listing the names of repackagers or distributors reasonably than the drugmaker itself. Pharmacists and probably well being care suppliers can present extra details about the supply of prescribed drugs.
This listing is present as of Aug. 4. The FDA can add or take away exempted medication at any time.
Firm Responses
ProPublica reached out to all of the drugmakers listed right here. Most didn’t reply.
Apotex didn’t reply to requests for remark. After the inspections that led to the import bans, the corporate informed the FDA that it could launch corrective actions and produce on a third-party guide, amongst different issues. The factories are not banned.
Divi’s Laboratories didn’t reply to requests for remark. In its response to the FDA on the time, the company said it employed third-party consultants and different specialists to resolve the FDA’s issues. The corporate additionally mentioned it had taken corrective actions on the facility. The manufacturing facility is not banned.
Emcure Prescribed drugs didn’t reply to requests for remark. In its response to the FDA on the time, the corporate mentioned it could revise procedures, present coaching and interact consultants, amongst different issues. The manufacturing facility remains to be banned however not has exemptions.
Glenmark Prescribed drugs didn’t reply to requests for remark. On the time of the ban, the corporate mentioned it could have interaction with the FDA to resolve the issues. The manufacturing facility remains to be banned however is not receiving any exemptions.
GPT Prescribed drugs didn’t reply to requests for remark. In its response to the FDA, the corporate defended the standard of its merchandise and mentioned it had introduced on a guide to audit the operation. The manufacturing facility is not banned.
In an announcement to ProPublica, Pfizer, which owns Hospira, mentioned it submitted a complete response to the FDA, paused manufacturing on the website after which offered the ability to a different firm in 2019. “We’re dedicated to working our manufacturing websites on the highest high quality requirements,” Pfizer mentioned. The manufacturing facility is not banned.
Intas Prescribed drugs, whose U.S. subsidiary is Accord Healthcare, mentioned in an announcement that the corporate has invested hundreds of thousands of {dollars} in upgrades and new hires and launched a companywide program targeted on high quality. Exempted medication have been despatched to the USA in a “phased method,” the corporate mentioned, with third-party oversight and security testing. Intas additionally mentioned that some exempted medication have been by no means shipped to the USA as a result of the FDA discovered different suppliers. The corporate wouldn’t present particulars. “Intas is nicely on its method in the direction of full remediation of all manufacturing websites,” the corporate mentioned. The 2 Intas factories are nonetheless banned and nonetheless receiving exemptions.
Ipca Laboratories didn’t reply to requests for remark. On the time, Ipca mentioned it was working to resolve the problems at a number of factories. “The corporate is dedicated to its philosophy of highest high quality in manufacturing, operations, programs, integrity and cGMP tradition,” Ipca mentioned, referring to “present good manufacturing practices,” a standard phrase within the trade. The factories are not banned.
Jubilant Generics didn’t reply to requests for remark. On the time, the company said it could “have interaction with the company to resolve the import alert on the earliest and guarantee cGMP compliance.” The manufacturing facility is not banned.
Shilpa Medicare didn’t reply to requests for remark. In a media statement on the time, the corporate mentioned it deliberate to resolve the FDA’s issues. “We uphold high quality and compliance with utmost significance and are dedicated to sustaining cGMP and high quality requirements throughout all Shilpa amenities.” The manufacturing facility remains to be banned and considered one of its drugs remains to be exempt.
Sri Krishna Prescribed drugs didn’t reply to requests for remark. The corporate on the time informed the FDA that it was utilizing a guide to audit operations and help in assembly manufacturing necessities. The manufacturing facility remains to be banned however is not receiving exemptions.
In an announcement to ProPublica, Solar Pharma mentioned that adherence to high quality requirements “is a high precedence for Solar, and we keep a relentless deal with high quality and compliance to make sure the uninterrupted provide of medicines to our clients and sufferers worldwide. We proceed to work proactively with the US FDA and stay dedicated to attain full decision of any FDA regulatory points at our amenities.” The manufacturing facility remains to be banned and nonetheless receiving exemptions.
Teva Prescribed drugs didn’t reply to requests for remark. The corporate mentioned in a statement on the time that it was working to keep away from drug shortages “whereas we deal with resolving regulatory issues, as sufferers are all the time highest precedence.” The manufacturing facility remains to be banned however not receiving exemptions.
Wockhardt didn’t reply to requests for remark. In a convention name with reporters on the time of the import ban, in response to Reuters, the Wockhardt chairman mentioned the corporate was “making all types of effort to fulfill” FDA good manufacturing requirements on the manufacturing facility. The factories are nonetheless banned, however in July, Wockhardt introduced that it could not make generics for the U.S. market.
Zhejiang Hisun Pharmaceutical didn’t reply to requests for remark. Based on a report in Bloomberg, Hisun mentioned on the time that it takes high quality significantly and has complied with necessities. The manufacturing facility is not banned.
Mylan/Viatris mentioned in an announcement to ProPublica that it instantly labored to resolve the FDA’s issues. “Affected person security stays our main and unwavering focus,” the company said. The manufacturing facility remains to be banned and nonetheless receiving exemptions.
A lawyer for Madhu Devices informed ProPublica in an e mail that the corporate has fastened all the issues recognized by the FDA and is cooperating absolutely. The manufacturing facility remains to be banned however not has an exemption.
Brandon Roberts and Irena Hwang contributed knowledge reporting.
