Two well -known US senators require nutrition and medicines to provide immediate accounting for foreign genetic drug producers that allow you to dew the ban intended to maintain dangerous medicines from the United States.
Leading Special Senate Committee Members referred to recent Investigation PROPUBLICA This exposed how the FDA quietly awarded special passes to the problematic manufacturers so that they can continue the delivery of medicines to Americans even after the agency banned their factories out of serious quality problems.
“These liberations undermine US policy policy, threaten drug safety and are at risk of Americans’ health,” the senators wrote in a two -party letter to Commissioner Marty Makari.
Chairman of the Committee Rick Scott, R-Fla., And Member of the Kirsten Gilibrand, DN.Y., described “Immediate problems” regarding the overseeing foreign manufacturers of the FDA drug and whether the drugs coming to the United States were safe.
PROPUBLICA has found that the agency has provided release from importing more than 20 foreign factories since 2013, including Plant Sun Pharma in India Where quality disorders have repeatedly risked contamination of sterile injection. Overall, when propublica found that the FDA has allowed more than 150 medicines or their ingredients from the prohibited factories, including antibiotics, drugs and chemotherapy.
The FDA noted that the release was used to prevent the lack of medicines. Practice, however, was largely stored by doctors, pharmacists, consumers and legislators. Despite the 2012 Law, which requires FDA to describe all the ways it was dealing with a drug deficiency, the agency does not mention the practice of Congress until 2024 – and even then, only then, In one footnotes With a 25-page report.
Scott said he was afraid for patients’ safety.
“We have seen that the FDA impose prohibitions on imports on foreign production facilities for violation of the basic quality and security standards, only for later editions … which allow drugs from the same objects that are still imported simply because they are on the lack of lack,” he said in a propublica. “This means that the FDA can allow potentially dangerous, poor drugs to American houses, and our elderly are especially at risk. This is unacceptable.”
Sun Pharma said she supports a “tireless emphasis on quality” and works with FDA to address regulatory issues. The FDA did not immediately respond to a comment request. Earlier, the agency stated that companies receiving exceptions from import ban were to conduct additional drug quality tests with other supervision to “help guarantee consumer security”.
Makari is new in the FDA: he took the helm of the agency earlier this year after he was appointed President Donald Trump and called for “radical transparency” when making the agency’s decision.
In a letter from Scott and Gilibrand there is a heel of the drug Senate, where the former FDA inspector, who spent many years in India and China, has repeatedly found “shortcuts and fraud” at poor factories and feared poor medicine to be supplied to the US mask.
“What we found was horrible,” said Peter Baker, who reported a number of failures abroad from 2012 to 2018.
Baker said his findings and the results of other inspectors were undermined by exceptions from importing imports.
For many years, inspectors have discovered dirty water, vials of medicines that were “black” from contamination and raw materials, soiled by unknown “foreign material” at foreign factories, state records show. Drug testing documents were destroyed, and in one case the workers poured acid on some that were packed into the garbage bag.
Propublica found decisions to overcome these findings and release drugs from importing imports, were made by a small, secret group of agencies insiders, which reported a long -standing drug security management Janet Woodk.
In an interview, WoodCock said propublica that the FDA believes that the drugs were released. “We felt that it was not necessary to do it in a public business,” she said.
The trees retired in 2024 after almost four decades at the agency.
In their letter to Makari, the senators asked the FDA to explain how it determines the drug deficiency and provide market share data for all drugs released from the import ban since 2020. They also asked for a complete list of these medicines.
FDA has never published such a list. PROPUBLICA has published one In August after a long investigation. Reporters used artificial intelligence and wrote a code that used keyword search and coordination to pull out the released drug names and production places from hundreds of old reports that were provided by the FDA and are no longer on the agency’s website. The reports revealed factories prohibited from drug delivery to the United States and sometimes referred to the release practically without explanation.
PROPUBLICA found that the FDA did not regularly check the released medicines to make sure they were safe or used their massive complaints related to drugs to actively monitor whether they are not suspended by patients.
“I am deeply concerned about the FDA scheme that allows foreign drug genetic manufacturers to export drugs to America, even if their facilities are below our standards,” Gilibrand said. “This is a threat to our elderly and our national security.”
Several home members also caused concern.
“The FDA should never have allowed corporations with dangerous foreign factories to import risky drugs and ingredients,” the representative of Chris Delusio, D-PA said. “We need a stronger and better home pharmaceutical production, and we need a government that refuses to mention the bones for our health.”
Senators asked the FDA to provide additional exceptions by mid -October. The Committee plans to hold a second hearing.
