{"id":12093,"date":"2020-04-17T14:18:10","date_gmt":"2020-04-17T18:18:10","guid":{"rendered":"http:\/\/airpurifierspecialist.com\/store\/?p=12093"},"modified":"2020-05-21T11:18:12","modified_gmt":"2020-05-21T15:18:12","slug":"exclusive-bayers-chloroquine-donation-to-u-s-raises-concern-about-fda-standards-in-pandemic","status":"publish","type":"post","link":"https:\/\/airpurifierspecialist.com\/store\/exclusive-bayers-chloroquine-donation-to-u-s-raises-concern-about-fda-standards-in-pandemic\/","title":{"rendered":"Exclusive: Bayer’s chloroquine donation to U.S. raises concern about FDA standards in pandemic"},"content":{"rendered":"
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(Reuters) – On March 21, two days after President Donald Trump first touted chloroquine drugs as a \u201cgamechanger\u201d in the fight against COVID-19, administration officials privately described what they felt was a \u201cwin\u201d in the president\u2019s efforts to build an emergency stockpile of the drugs: a hefty donation of pills from Bayer AG. BayGn.DE <\/p>\n

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FILE PHOTO: A bridge is decorated with the logo of a Bayer AG, a German pharmaceutical and chemical maker in Wuppertal, Germany August 9, 2019. REUTERS\/Wolfgang Rattay<\/span><\/p>\n<\/figcaption><\/div>\n<\/div>\n

In an exchange of enthusiastic emails among federal health officials reviewed by Reuters, Keagan Lenihan, chief of staff of the U.S. Food and Drug Administration (FDA), cautioned that \u201c3-4 days\u201d of testing would be needed. <\/p>\n

\u201cPotentially serious issues with product so let\u2019s be careful when we take that win,\u201d she wrote. <\/p>\n

Bayer has since donated three million tablets of the drug, called Resochin, to the U.S. national stockpile for treatment of COVID-19, the disease caused by the coronavirus. After a brief period of testing, its use in the United States was approved on an emergency basis. <\/p>\n

But three U.S. government sources familiar with the matter told Reuters that there is reason to be concerned about the quality of Resochin and its makers, located in India and Pakistan. <\/p>\n

Although some rules can be waived in an emergency, the FDA dropped its quality-control standards too far as it scoured the world for scarce supplies of chloroquine drugs, according to the sources, who spoke on condition of anonymity. <\/p>\n

The plants that make Resochin ingredients and finished doses in India and Pakistan have never been registered with, or inspected by, the FDA, according to the three government sources, as well as FDA documents compiled in the private online database FDAzilla.com. Some chloroquine drugs were already approved by the FDA before the pandemic as antimalarial medications, a process that required plant inspections. Resochin was not approved. <\/p>\n

Pakistani regulators, who inspected Bayer\u2019s Resochin plant in Karachi in 2015, found a \u201cgross failure\u201d in manufacturing processes there, according to documents from the Drugs Regulatory Authority of Pakistan, reviewed by Reuters. And though the FDA has never screened the Indore, India, plant that supplies ingredients for Resochin, the U.S. agency has inspected other Indian plants run by the same Indian supplier and found serious deficiencies, including falsification of records, inspection documents spanning 2014 through 2019 show. <\/p>\n

Responding to questions from Reuters about Resochin, FDA spokesman Michael Felberbaum said that the agency \u201csampled and tested the donated drugs to evaluate acceptability for importation\u201d and they met appropriate standards. <\/p>\n

Asked about Lenihan\u2019s March 21 email, the FDA spokesman said the agency \u201cdoes not comment on alleged, leaked emails.\u201d <\/p>\n

In a statement to Reuters, Bayer said that the FDA had tested Resochin \u201cand found it to be of appropriate quality for release to the (stockpile) for emergency use. We are proud to make this donation to the U.S. government in the fight against COVID-19.\u201d <\/p>\n

Resochin is part of a class of medications containing one of two active ingredients – chloroquine or hydroxychloroquine – that the Trump administration has praised as a potentially lifesaving treatment. But the effectiveness of chloroquine drugs against coronavirus has not been proven. Though in use for years in the United States as a treatment for malaria and autoimmune conditions such as lupus, the medicines can have serious side effects, including heart arrhythmias. <\/p>\n

The three U.S. sources who spoke with Reuters, as well as an independent expert, said spot-testing is not always sufficient to ensure a drug\u2019s safety and effectiveness, and plant inspections normally done by the FDA are crucial to ensuring overall quality. <\/p>\n

\u201cIf you\u2019re talking about millions of doses, you can\u2019t test every product,\u201d said Stephen Payne, who for years chaired a practice group specializing in the FDA and health care at a global law firm. \u201cYou have no idea what you don\u2019t know.\u201d <\/p>\n

A PHOTO OPPORTUNITY <\/h3>\n

Trump first endorsed chloroquine drugs to treat COVID-19 from the White House podium on March 19, citing \u201cvery, very encouraging early results\u201d and downplaying any risks. \u201cIf things don\u2019t go as planned, it\u2019s not going to kill anyone,\u201d he said. <\/p>\n

The statements came as the administration was being hammered for its slow response to the growing coronavirus crisis, which to date has infected more than 637,000 people in the United States, killing almost 31,000. His comments set high public expectations for the drugs, which are now being snapped up all over the globe. <\/p>\n

In emails two days later, federal health officials greeted the Bayer donation of chloroquine phosphate, or Resochin, with eagerness. <\/p>\n

Cicely Waters, director of external affairs for the U.S. Department of Health and Human Services (HHS), saw a media opportunity. A shipment of two million tablets was due to arrive at John F. Kennedy International Airport in New York City. <\/p>\n

\u201cI would like to get photos of the product coming off of the FedEx plane so we can be prepared to support the story with visuals if this turns out the way we hope,\u201d wrote Waters. <\/p>\n

Lenihan of the FDA told the group of health officials that \u201cif it is the product we think it is and it is not toxic we will release it to ASPR\u201d – the Assistant Secretary for Preparedness and Response, a division within HHS. <\/p>\n

Reached by email, Lenihan referred Reuters back to the FDA press office. Waters did not respond to an email seeking comment. <\/p>\n

One of the participants in the March 21 email discussion appeared to raise the issue of which agency should get credit for the deal. Joseph Hamel, ASPR\u2019s manager of strategic innovation and emerging technology, asked in an email to the group: \u201cHow do you want to handle? FDA win? ASPR win? Happy either way, please let us know.\u201d <\/p>\n

Hamel did not return an email seeking comment. <\/p>\n

Asked about the email exchanges, an HHS spokesman echoed the FDA\u2019s statement, saying the agency would not comment on \u201calleged, leaked emails.\u201d <\/p>\n

\u2018GROSS FAILURE\u2019 <\/h3>\n

The pills and ingredients welcomed by the administration had origins that should have raised red flags and prompted greater scrutiny, said the three sources who spoke to Reuters. <\/p>\n

In 2015, Bayer\u2019s plant in Pakistan, Bayer Pakistan Private Ltd, was cited by that country\u2019s regulators for making Resochin that was lower in potency than labeled, according to inspection documents reviewed by Reuters. <\/p>\n

A whistleblower complaint led to the discovery of more than 21 million Resochin tablets that were too weak, more than 12% under the specified weight of 400 milligrams, according to the Pakistani regulatory records. <\/p>\n

Officials blamed the problem on a \u201cgross failure\u201d of manufacturing operations, citing improperly calibrated machines, poorly trained workers and insufficient staffing. Weak medications can fail to treat the illness for which they\u2019re prescribed and harm patients. <\/p>\n

The investigation was ultimately resolved with Bayer\u2019s agreement to destroy the 21 million doses. <\/p>\n

Regarding the 2015 incident, the company told Reuters: \u201cAll batches produced with lower content due to an error in production were never released, the corresponding batches destroyed.\u201d <\/p>\n

According to FDA records reviewed by Reuters, the active ingredients for the drug are made at a plant in Indore, India, run by Ipca Laboratories Ltd, an Indian drug manufacturer and ingredient supplier that exports its products globally. <\/p>\n

In 2016, the FDA issued a warning letter to Ipca regarding three of its plants in India that make chloroquine ingredients and finished pills for companies other than Bayer. The plants did not include the one making the active ingredient for Bayer\u2019s Resochin. Nonetheless, the U.S. government sources said, Ipca\u2019s troubled history calls into question its general practices. <\/p>\n

The FDA found the company was deleting, manipulating and fabricating laboratory data, according to the agency\u2019s records. The company vowed at the time to \u201cresolve these issues at the earliest.\u201d <\/p>\n

In 2017, the agency restricted drugs and ingredients from those three plants from entering the U.S. market, a regulatory sanction called an import alert. Then in August 2019, the FDA accused one of the Ipca plants of a \u201ccascade of failure\u201d for not properly maintaining its quality data, agency records show. <\/p>\n

Ipca did not respond to questions from Reuters about its track record with the FDA. <\/p>\n

On March 20, a day after Trump praised the antimalarial drug from the podium, the FDA lifted its import alert for Ipca\u2019s chloroquine ingredients and completed tablets from the three restricted plants, according to a March 21 statement filed by Ipca with the Indian stock exchange. <\/p>\n

The company pledged in the statement to adhere to stringent manufacturing standards, \u201cand thus help mankind in the best possible way in these testing times.\u201d <\/p>\n

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Katherine Eban reported from New York; Editing by Elyse Tanouye and Julie Marquis<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

Read More<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

(Reuters) – On March 21, two days after President Donald Trump first touted chloroquine drugs as a \u201cgamechanger\u201d in the fight against COVID-19, administration officials privately described what they felt was a \u201cwin\u201d in the president\u2019s efforts to build an emergency stockpile of the drugs: a hefty donation of pills from Bayer AG. BayGn.DE FILE…<\/p>\n","protected":false},"author":1,"featured_media":12094,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[],"_links":{"self":[{"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/posts\/12093"}],"collection":[{"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/comments?post=12093"}],"version-history":[{"count":1,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/posts\/12093\/revisions"}],"predecessor-version":[{"id":16509,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/posts\/12093\/revisions\/16509"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/media\/12094"}],"wp:attachment":[{"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/media?parent=12093"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/categories?post=12093"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/airpurifierspecialist.com\/store\/wp-json\/wp\/v2\/tags?post=12093"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}