For over ten years, the administration for nutrition and medicines has quietly allowed substandard foreign plant to continue delivery of medicines to the US even after the agency officially banned it from the dangerous failure.
PROPUBLICA exposed the little -known practice in June. The FDA said the decisions on the release of certain drugs from the ban on imports were made to retreat drug deficiency, and that the fences were created to ensure the safety of products, such as the need for prohibited factories to make additional drug tests before they were sent to the Americans.
But the agency itself did not regularly check the drugs or actively monitor the reports submitted by doctors, and others who described drugs with an unpleasant odor, pathological taste or residues, or consumers who felt sudden or unexplained health problems. The FDA warns that the results described in the complaints may not have drug associations or may be unexpected side effects. But drug safety experts say that without further study it is impossible to find out whether people have suffered or how much.
The FDA has retained exceptions to a large extent hidden from the public and has never released a comprehensive drug list admitted to the United States from prohibited factories. Propublica issues this list today.
The list presents the names of drugs and ingredients that propublica identified how released from the ban on imports from 2013, and the names of the manufacturers that made them. The names of the products are written as they appeared on the FDA import announcement list. Most factories are no longer prohibited in this list, so their drugs enter the country on ordinary channels. FDA raises bans after objects make all the necessary fixes.
Some of the factories are still prohibited -and may still be sent to the United States, which stand out in yellow.
Overall, PROPUBLICA has identified more than 150 released products, mostly from factories in India. One plant in China and one plant in Hungary also received exceptions. Several factories make drug ingredients, which are then sent to manufacturers that produce pills, capsules, tablets or injections.
To make a list of released drugs and ingredients, journalists pulled historical records from the Internet and used Systems RedicaQuality and regulatory intelligence campaign with a wide collection of agency documents.
Completing its analysis, Propublica counted all the medicines and ingredients that were released from each prohibited factory. Sometimes the same product was released from several factories and was added to the total number of factories. In several cases, the FDA released several drugs – such as a tablet, capsule or injection – the same drug. PROPUBLICA considered these different forms as different drugs.
To do this, the PROPBLICA list included only every drug once for each manufacturer.
General drugs can have a lot of manufacturers, and it can be difficult to find out on the basis of information provided on the bottle with medicines where drugs were made or who. Sometimes the bottles list the names of repackers or distributors, not drug manufacturer. Pharmacists and possibly medical workers can provide additional information about the source of the prescribed medicines.
This list is relevant as of August 4. FDA can add or remove the released medicine at any time.
Company’s answers
PROPUBLICA addressed all the narcotics listed here. Most did not respond.
Apotex did not respond to comment requests. Following the inspections that led to the ban on imports, the company said the FDA that, among other things, to launch corrective actions and attract a third consultant. The factories are no longer prohibited.
Divi laboratories did not respond to comment requests. In response to FDA at a time said the company He hired other consultants and other experts to solve FDA problems. The company also stated that it had taken corrective actions at the facility. The plant is no longer forbidden.
Emcure Pharmaceuticals did not respond to comment requests. In response to the FDA at the time, the company said it would revise the procedures, provide training and attract consultants, among other things. The plant is still forbidden, but no longer exceptions.
Glenmark Pharmaceuticals did not respond to comment requests. At the time of the ban, the company said it would be engaged in the FDA to solve problems. The plant is still forbidden, but no longer receives exceptions.
GPT Pharmaceuticals did not respond to comment requests. In response to the FDA, the company defended the quality of its products and stated that it had led to a consultant to check the operation. The plant is no longer forbidden.
In a statement by Propublica, Pfizer, owned by Hospira, said he presented a comprehensive response to the FDA, stopped at the production on the site and then sold the facility of another company in 2019. “We strive to manage our production sites by the highest quality standards,” Pfizer said. The plant is no longer forbidden.
Intas Pharmaceuticals whose subsidiary is Healthcare AgreementThe statement said the company has invested millions of dollars in modernization and new hiring, and launched the program across the quality -oriented company. The released drugs were sent to the United States by “gradual”,-said the campaign with the supervision and testing of security. Intas also stated that some released drugs have never been sent to the US because the FDA found other suppliers. The company would not provide details. “Intas goes on the way to the complete restoration of all production sites,” the company said. Two intas factories are still prohibited and still get exceptions.
IPCA laboratories did not respond to comment requests. At the time, IPCA said he was working on solving problems at several factories. “The company strives for its highest quality philosophy in the production, operations, systems, integrity and culture of CGMP,” the IPCA said, citing “modern good production practices”, the usual phrase in the field. The factories are no longer prohibited.
The jubilee generics did not respond to the requests for comment. At the time said the company This “would interact with the agency to resolve import warning and ensure CGMP.” The plant is no longer forbidden.
Shilpa Medicare did not respond to comment requests. In Media’s statement At the time, the company said it plans to solve the problems of the FDA. “We support the quality and maintain maximum importance and strive for maintaining CGMP standards and quality in all SHILPA facilities.” The plant is still forbidden, and one of its medicines is still released.
Sri Krishna Pharmaceuticals did not respond to comment requests. The company at the time said FDA that she was using an audit consultant and assistance in meeting production requirements. The plant is still forbidden, but no longer receives exceptions.
In his statement propublica, the Sun Pharma, which meets the quality standards, “is a top priority for Sun, and we maintain tireless attention to the quality and preservation to provide continuous supplies for our customers and patients worldwide. We continue to actively work with the US FDA and remain committed to reaching the full staging of any FDA.” The plant is still forbidden and still gets exceptions.
Teva Pharmaceuticals did not respond to comment requests. Said the company In the statement At a time when he worked to avoid a shortage of drugs, “while we focus on solving normative problems, as patients are always the highest priority.” The factory is still forbidden, but no longer works.
Wockhardt did not respond to comment requests. During the conference with journalists during the ban on imports, reports ReutersWockhardt chairman said the company is “making every effort to meet” FDA good production standards at the plant. The factories are still prohibited, but in July, Wockhardt announced that he would no longer make generics for the US market.
Zhejiang Hisun Pharmaceutical did not respond to comment requests. According to the report in BloombergGisun said at the time that he perceives the quality seriously and fulfills the requirements. The plant is no longer forbidden.
Mylan/Viatris said in a propublica statement that he immediately worked on solving FDA problems. “Patients’ security remains our core and unwavering attention” said the company. The plant is still forbidden and still gets exceptions.
The Madhu Instruments Lawyer told Propublica in an email that the company has fixed all the problems identified by the FDA and cooperates fully. The plant is still forbidden but no longer release.
Brandon Roberts and Irena Khvang included in the data report.
