Troubled Overseas Drugmakers Get Free Pass in Coronavirus Crisis
Troubled Overseas Drugmakers Get Free Pass in Coronavirus Crisis
(Bloomberg) -- U.S. regulators are allowing overseas pharmaceutical plants with checkered safety and quality records to make prescription drugs for Americans in an effort to fill supply gaps caused by the coronavirus pandemic.
Medications needed to care for the sickest virus patients are becoming more scarce at the same time that a surge in U.S. infections is forcing hospitals to stretch staff, beds and supplies of protective equipment. In an attempt to bolster the drug supply, companies in India are stepping in despite U.S. inspectors having flagged their facilities for poor sanitation, manipulation of quality-control data and other infractions.
Experts who watch drug supplies closely have warned of possible shortages triggered by the pandemic. Higher-than-normal demand for a range of medications is straining a supply chain that was never built to seamlessly handle a historic public-health shock.
The Food and Drug Administration on Wednesday added to its shortage list a paralytic necessary to sustain patients with Covid-19, the disease caused by the coronavirus, on ventilators. A day earlier, the agency said an injectable form of a diuretic called furosemide, given to patients whose lungs fill with fluid, was in short supply.
Also hard to get: A pair of anti-malaria medicines touted without clinical evidence by President Donald Trump as potential treatments for Covid-19.
The deficits have placed pressure on the FDA to help replenish inventories, even if that means opening the U.S. market to drugmakers that haven’t met the agency’s standards in the past.
Last month, the FDA allowed India-based Ipca Laboratories Ltd. to make the malaria drugs, hydroxychloroquine and chloroquine, in factories the agency had once prohibited from sending product to the U.S. A surge in demand for the drugs has left patients who take them for lupus and rheumatoid arthritis searching for ways to fill their prescriptions.
The FDA has also cleared the way for the U.S. government to place millions of doses of hydroxychloroquine and chloroquine in the strategic stockpile for hospitalized Covid-19 patients.
Bayer AG, which donated one million chloroquine doses to the U.S. stockpile, is a customer of Ipca’s, the Indian drugmaker says on its website. Their chloroquine isn’t approved in the U.S., though the FDA tested the drugs that were added to the national stockpile.
The FDA found the medicines were “of appropriate quality for release to the SNS for emergency use,” Chris Loder, a spokesman for Bayer, said in an email.
A representative of the FDA declined to comment.
Blind Spots
The FDA doesn’t have the capacity to test every drug sent to the U.S., but it does have broad authority to inspect overseas manufacturers that sell drugs to American consumers. However, the agency has had to pull nearly all its inspectors from the field to shield them from the coronavirus. That has limited its ability to make sure basic safety and sanitation standards are being observed in pharmaceutical plants around the world.
“I think FDA has a hard balance,” said Erin Fox, a drug-shortage expert at the University of Utah. “They’re under a lot of pressure to make sure there is access to product. It is concerning whenever FDA allows in product from manufacturers they know are not following the rules. I think it sets a bad precedent because it could encourage other companies to cut corners and not follow the rules.”
About 90% of the drugs Americans take are generics, and many are made in India, either by companies that sell directly to the U.S. market, that make active ingredients, or that make drugs under contract for other pharmaceutical companies.
In recent years, questions have been raised about the safety and efficacy of pills made in India and other countries. A wave of recalls of cardiovascular drug valsartan for potential carcinogen contamination included many versions made in India. Before the pandemic, the FDA faced scrutiny of its capacity to oversee generic-drug makers outside the U.S.
Ipca’s factories were put on so-called import alert in 2015 after FDA inspectors cited them for “systemic data manipulation” during routine testing. Despite its past troubles, Ipca said in an email it is prepared to meet U.S. manufacturing standards “and thus help mankind in the best possible way in these testing times.”
According to the FDA database, the diuretuc furosemide is in short supply because of increased demand and delays in shipping. Forty-four million furosemide prescriptions were filled last year, according to Bloomberg Intelligence data, though the bulk were in pill form and not the injectable version that’s now in demand. Ipca has been making furosemide out of one of its banned factories under an agreement with the FDA since the sanctions were put in place.
Second Chances
Ipca said it is among the largest manufacturers of the active ingredients and finished versions of furosemide, hydroxychloroquine and chloroquine. “We have been manufacturing and supplying these APIs and its formulations world over uninterrupted for the past several decades,” the company said.
The FDA doesn’t end up banning a factory every time it uncovers substandard manufacturing practices; often it works out mitigation strategies with the company. Those negotiations can take years and drugmakers can still gain approval to make new treatments in the meantime.
Cipla Ltd., also based in India, was warned by the FDA in February for failing to sanitize its equipment appropriately to prevent contamination at one of its factories and decided to suspend production of some sterile products. Cipla received FDA approval Wednesday to make a generic version of an inhaled drug called albuterol that is being used to help Covid-19 patients relax airway muscles.
“The FDA recognizes the increased demand for albuterol products during the novel coronavirus pandemic,” FDA Commissioner Stephen Hahn said in a statement. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public.”
©2020 Bloomberg L.P.