Federal authorities have seized from U.S. airports unauthorized versions of the Covid-19 treatment remdesivir intended for distribution in Mexico, the government’s latest effort to eradicate criminal activity linked to the pandemic.
Counterfeit or generic versions of remdesivir, an antiviral manufactured by Gilead Sciences Inc., arrive in the United States by air from Bangladesh and India and are smuggled by individuals into Mexico for patients willing to pay top dollar for the drugs, people familiar with the drug said. ‘investigation.
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In recent months, U.S. Customs and Border Protection officials have captured more than 100 shipments that they have returned to U.S. Department of Homeland Security special agents for further investigation, according to the people. .
DHS agents have coordinated tests to determine whether the confiscated items are counterfeit or generic, according to people. Generic forms of remdesivir are not authorized for use in the United States or Mexico. In most cases, it is illegal in the United States to market or import prescription drugs without a license.
Counterfeit prescription drugs typically include fraudulent labeling on a container, with another drug, or just water or saline inside, according to industry and safety experts. The counterfeit prescription drug market is valued at over $ 200 billion annually, according to PricewaterhouseCoopers.
Demand is high for Gilead’s remdesivir in Mexico, as the country only recently authorized its use, people familiar with the matter said. Mexican health authorities and the attorney general’s office did not respond to requests for comment.
Remdesivir, first cleared by U.S. regulators last year at the start of the pandemic, has been shown to provide only a modest benefit. But demand has increased in some countries, with the drug now part of the standard of inpatient care, largely due to the limited arsenal of tools available to doctors to treat Covid-19 patients. .
Authorities outside the United States have been investigating counterfeit or unlicensed remdesivir for months. Colombian authorities seized containers of a generic version of remdesivir in January from a woman at an airport who said the drugs were a Covid-19 vaccine, local officials said. Indian authorities said they arrested a handful of people in connection with counterfeit remdesivir during raids in April and May; in one case, the suspects changed the labels and packaging of an antibiotic.
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“You have to remember that if you don’t have easy access to a vaccine and your healthcare system is in danger of collapsing, you will try anything,” said Shabbir Safdar, executive director of Partnership for Safe Medicines, an American nonprofit organization. group whose members include professional groups of pharmacists and the pharmaceutical industry.
He said people outside the United States sometimes engage in what’s called brown-bagging, in which they buy prescription drugs on the street and ask doctors to administer them.
“With the potential for Covid to be fatal, people are thinking, ‘Yes, I will buy remdesivir if I can find it and take it to the hospital,’” he said.
Gilead, based in Foster City, Calif., Said he was working with law enforcement agencies around the world to combat the threats that counterfeit and substandard pharmaceuticals pose to patients, including investigations involving remdesivir.
“We caution against sourcing Gilead drugs outside of the approved and regulated supply chain, hospitals or pharmacies and will continue to support US law enforcement by taking appropriate steps to protect patients.” , the company said.
Over the past three years, law enforcement around the world has detained nearly $ 12 billion in contraband drugs, according to the Pharmaceutical Security Institute, a trade group.
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For more than a year, the US government has been investigating fraud linked to the Covid-19 pandemic, recovering fake masks, personal protective equipment and other products. He is also working with pharmaceutical companies on investigations related to their Covid-19 products, including counterfeit snapshots of the Covid-19 vaccine from Pfizer Inc. and BioNTech SE.
Remdesivir was cleared for emergency use by the United States Food and Drug Administration last spring and received full approval in October 2020. The intravenous drug is sold under the brand name Veklury and has a price tag US catalog for $ 520 per vial, or $ 3,120 for a typical course. treatment. The US government and other developed countries can purchase a vial for $ 390.
In the U.S. investigation, CBP agents seized boxes of products in Texas and New York from India and Bangladesh, according to people familiar with the investigation.
The seized items are mostly packaged in 10-vial packs under generic names, not Veklury, and they are labeled as medical samples or test kits, according to the people. They say the drugs are shipped in packages and not carried by passengers, and are then smuggled by individuals into Mexico.
No arrests were made and more details were not available as the investigation is ongoing, people said.
Companies in India, Egypt and Pakistan are manufacturing generic forms of remdesivir, after Gilead last year agreed to clear production through a program that the company says has enabled more than 2.3 million people in more than 60 developing countries use the drugs. Gilead has authorized generic versions of its product for distribution in more than 100 countries.
Mexican regulators cleared the drug for use in treating Covid-19 patients in March. US officials have seen generic forms of remdesivir for sale in Mexico, people said.
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Under Mexican authorization, state governments can purchase Veklury and patients can access the drug through local government health care providers, a company spokesperson said. He said Gilead hopes to get full approval, which would expand the offer to the private sector.
Some companies in Hungary, Russia and Bangladesh have produced generic copies of the drug Gilead without a company license, including through compulsory licenses granted by their governments. Countries can grant such licenses to drug manufacturers, allowing them to copy a company’s patented drugs without its approval, under international rules of the World Trade Organization.
Gilead declined to comment on or verify the authenticity or effectiveness of these products. He also declined to comment on whether people were involved in alleged smuggling operations.
—José de Córdoba and Rajesh Roy contributed to this article.
Write to Jared S. Hopkins à [email protected]