6-13-19 118 facilities in Shandong and Jiangsu are FDA-approved, which indicates a heavy reliance on the US market. https://www.pharmaceutical-technology.com/comment/china-pharmaceutical-industry-2019/
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8-21-19 US Treasury’s Office of Foreign Assets Control (OFAC) identified Chinese national Fujing Zheng and the Zheng Drug Trafficking Organization as significant foreign narcotics traffickers pursuant to the Foreign Narcotics Kingpin Designation Act. OFAC also designated one additional Chinese national, Guanghua Zheng, for his support to the Zheng DTO’s drug trafficking activities, as well as one Chinese entity, Qinsheng Pharmaceutical Co. Ltd., for being owned or controlled by Fujing Zheng. OFAC is also identifying Xiaobing Yan as a significant foreign narcotics trafficker pursuant to the Kingpin Act. https://home.treasury.gov/news/press-releases/sm756
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9-9-19 the Food and Drug Administration has rejected a petition filed by a consumer advocacy group calling for the agency to impose a moratorium on the approval of any new or reformulated opioids. In arguing for the moratorium Public Citizen maintained last March that the FDA displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provided benefits that outweighed the risks. https://www.statnews.com/pharmalot/2019/09/09/fda-opioids-moratorium-petition/
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Furthermore, a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market. 2°
Finally, we note that a moratorium on new approvals is not necessary to guard against the possibility that a product approved today might, in the future, either under an altered regulatory framework or based upon new evidence, not be considered to have a favorable benefit-risk profile. Response_Letter_(_Denial)_from_FDA_CDER_to_Public_Citizen’s_Health_Research_Group.pdf (pg. 6)
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Fentanyl sourced from China accounted for 97 percent of the drug seized from international mail services by United States law enforcement in both the 2016 and 2017 fiscal years, according to the Drug Enforcement Administration.
China’s new focus on shutting down the trade has meant shipments of fentanyl to the United States have declined significantly in the last year, according to Chinese officials, citing figures from the United States Customs and Border Protection agency. The American agency did not dispute that drop.
“China’s control over fentanyl substances is becoming stricter and stricter,” said Yu Haibin, the deputy director of the country’s National Narcotics Control Commission.
Following a tightening of drug controls that took effect May 1, the government put 91 manufacturers and 234 individual distributors under “strict supervision,” warning them not to export fentanyl or related drugs , like carfentanil , according to a government report released in September. It claimed to have increased inspections and arrests in 13 cities and regions where pharmaceutical companies have proliferated….
In the 2019 fiscal year that ended in October, American customs agents seized 1,154 kilograms of fentanyl, or 2,545 pounds, compared with 31 kilograms, or 70 pounds, in 2015….manufacturers and distributors that had operated in the open may simply shift their operations underground.
“The scale of China’s under-regulated industries allows for minimally trained technicians with access to the proper inputs to follow simple synthesis steps while avoiding oversight,” the authors of a new report on fentanyl by the RAND Corporation wrote….Mr. Yu, the narcotics agency deputy director, cited statistics from the United States Customs and Border Protection showing that of the 536.8 kilograms of fentanyl seized between October 2018 and March 2019, only 5.87 kilograms, or just over 1 percent, was shipped from China. From these statistics it is clear that China is not the main source of fentanyl substances in the United States,” Mr. Yu said….
The Zheng company appears to have closed — or gone underground — but the two men are believed to be at large. https://www.nytimes.com/2019/12/01/world/asia/china-fentanyl-crackdown.html
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1-8-19 There’s growing evidence that illicit fentanyl is being produced primarily in Mexico in clandestine cartel labs, with precursor chemicals sourced from China. fentanyl lab seizures were in Sinaloa in 2017 and in the border city of Mexicali in September, when authorities found 20,000 fentanyl pills and arrested two men, including a Russian national….
“The Sinaloa cartel said ‘We learned how to make this pure product, but we can’t make enough of it,’” Ciccarone said. “We’re going to have to boost it, dilute it, spread it out, with fentanyl in order to feed the East Coast.”…According to testimony delivered to Congress last May, Customs and Border Protection seized roughly 240 pounds of fentanyl from “express consignment carriers” such as FedEx in the 2017 fiscal year, and another 92 pounds that smugglers attempted to ship through the postal system. Over the same time period CBP seized more than twice as much fentanyl — approximately 853 pounds — at ports of entry along the Mexican and Canadian borders. The most recent data available for the 2018 fiscal year shows that CBP made fentanyl seizures of 1,357 pounds at points of entry, plus 338 pounds confiscated by Border Patrol agents away from official crossing points.
The DEA estimates that it costs about $3,300 to make one kilo of fentanyl, but according to sources involved in the drug trade in Culiacán, Sinaloa, who spoke VICE News on the condition of anonymity, cartel cooks charge as little as $2,000 per kilo. Pure kilos of fentanyl are said to sell to mid-level dealers in Culiacán for around $45,000, then mixed with heroin and stretched into eight or nine kilos of blended product, which retail for $35,000 per kilo in Los Angeles or over $50,000 on the East Coast. By comparison, a single kilo of regular heroin typically costs $28,000 to buy and ship across the border, where it sells for around $60,000.
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4-27-18 The problem, Levin says, has been the health care industry’s reliance on opioids….the US faces a crisis that Levin says costs the nation’s health care system $1.3 trillion and kills 63,000 people a year. https://wxpress.wuxiapptec.com/top-biopharma-executive-jeremy-levin-leads-bios-efforts-battle-opioid-crisis/
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8-21-19 US Treasury’s Office of Foreign Assets Control (OFAC) identified Chinese national Fujing Zheng and the Zheng Drug Trafficking Organization as significant foreign narcotics traffickers pursuant to the Foreign Narcotics Kingpin Designation Act. OFAC also designated one additional Chinese national, Guanghua Zheng, for his support to the Zheng DTO’s drug trafficking activities, as well as one Chinese entity, Qinsheng Pharmaceutical Co. Ltd., for being owned or controlled by Fujing Zheng. OFAC is also identifying Xiaobing Yan as a significant foreign narcotics trafficker pursuant to the Kingpin Act. https://home.treasury.gov/news/press-releases/sm756
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10-19-18 The Zheng drug trafficking organization was hardly clandestine. The Shanghai-based network sold synthetic narcotics, including deadly fentanyl, on websites posted in 35 languages, from Arabic and English to Icelandic and Uzbek.
The Chinese syndicate bragged that its laboratory could “synthesize nearly any” drug and that it churned out 16 tons of illicit chemicals a month. The group was so adept at smuggling and so brazen in its marketing that it offered a money-back guarantee to buyers if its goods were seized by U.S. or other customs agents.
Over the last decade, federal officials say, the Zheng group mailed and shipped fentanyl and similar illicit chemicals to customers in more than 25 countries and 35 U.S. states. U.S. officials say the syndicate’s success, laid bare in a recent federal indictment, partly helps explain America’s skyrocketing death toll from drug overdoses. …
in August, federal prosecutors in Cleveland unveiled a 43-count indictment against the Zheng organization. It alleged that
U.S. officials said the Zhengs were adept at staying ahead of regulators — and police. When China banned unregulated production of one synthetic narcotic, officials said, the Zhengs used their expertise to adjust the formula to skirt the prohibitions and keep the drugs flowing.
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8-24-18 The Zhengs and their partners used numerous companies, includingGlobal United Biotechnology, Golden Chemicals, Golden RC, Cambridge Chemicals, Wonda Science and others to manufacture and distribute hundreds of controlled substances, including fentanyl analogues such as carfentanil, acetyl fentanyl, furanyl fentanyl and others. They created and maintained numerous websites to advertise and sell illegal drugs in more than 35 languages….
Zheng used companies run by Massachusetts-based co-conspirator Bin Wang to smuggle drugs past customs agents in China and the United States. Wang then shipped the drugs to customers across the country. He has pleaded guilty to his role in the conspiracy and is scheduled to be sentenced on November 13….
Last month the Zheng organization agreed to manufacture adulterated cancer medication, creating counterfeit pills that replaced the active cancer-fighting ingredient with dangerous synthetic drugs. It also created and shipped counterfeit Adderall pills that were adulterated with deadly bath salts.
The Zheng group laundered its drug proceeds by using digital currency such as Bitcoin, transmitted drug proceeds into and out of bank accounts in China and Hong Kong, and bypassed currency restrictions and reporting requirements. http://gangstersinc.ning.com/profiles/blogs/zheng-inc-how-two-chinese-nationals-operated-global-opioid-and-dr
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Among the 5,000 apartments, on a high-rise’s 20th floor, lives
Yan Xiaobing, a chemicals distributor with short, spiky hair. His wife, Hu Qi, operates an English tutoring business. Their social-media feed shows the couple and their two young children under blue skies at the beach and posing at landmarks in Europe and Japan. One photo shows Yan reading to pupils in a classroom.
In half-frame glasses, blue plastic house slippers and button-down shirt, Yan could have passed as an ordinary office worker when Bloomberg News reporters found him late last year. Filling the apartment doorway with his 6-foot frame, he expressed soft-spoken bafflement at the portrait the U.S. Justice Department paints of him: not a modest businessman, but a new type of international drug dealer. “This is horrifying,” he said. “Their investigation must have gone wrong.”
…Gulfport police Sergeant Gibbons obtained a search warrant for a Yahoo email account created by Muhammad and spotted the drugs' source: Yan Xiaobing in Wuhan. A Sept. 14, 2011, message to Yan read: “Can I pay to have this stuff shipped faster? I need this stuff like yesterday,” referring to JWH 210, a synthetic cannabinoid.
Using the alias William Zhou, Yan confirmed the shipment with a tracking number. “UPS is the fastest way to USA, we have tried our best to send it quickly and charge no extra fee,” he wrote. A similar compound, he wrote, “is just out of stock, the new batch will be ready tonight, so we will send it tomorrow. Since September, the purchase amount are soaring, so we will increase human power and equipment to expand the production capacity.” He signed it, “Best regards.” On Aug. 10, 2012, Yan sent Muhammad’s account a price list for 26 mind- and body-altering chemicals ranging from $1,400 to $3,600 per kilo.
(Chapman and Muhammad would later get prison sentences of nearly 17 and 120 years, respectively.
Federal prosecutors in Mississippi charged Yan, 41, in September with leading an empire built on the manufacture and sale of drugs related to fentanyl, one of the world’s deadliest and most profitable narcotics….
Because Yan used Gmail, operated by U.S.-based Google, Gibbons and his team could persuade a judge to let them monitor his communications in real time. What they found broke the dam: Yan wasn’t just selling fake weed and bath salts to Muhammad in Connecticut. Gibbons said he was peddling fentanyl analogues around the globe.
"This guy has hooks all over the place,” Gibbons recalled thinking as he traveled to New Orleans; Baltimore; Portsmouth, New Hampshire and dozens of other cities to track down buyers. Metcalf, the intelligence analyst, worked the international angle, alerting his counterparts about customers in Russia, Kuwait, Sweden, Brazil and 16 other countries. They went undercover as distributors, prompting Yan to send them seven shipments containing kilograms of fentanyl analogues and other synthetics. Yan labeled the packages as clothing, buttons, radios and cleaning supplies, and when Gibbons claimed that one had been confiscated by customs, Yan sent another for free.
By the time of the indictment, investigators had tied Yan to at least two Chinese factories equipped to produce deadly chemical compounds by the ton. The indictment charges Yan with conspiring to manufacture and import 22 substances banned in the U.S. over six years beginning in 2010. Included on the list are four fentanyl analogues — none of which were illegal in China at the times he’s accused of sending them to Mississippi. That wasn’t by accident, Gibbons said. “He stayed abreast of the law to stay ahead of it.” …
-Qilai Shen/Bloomberg: Wuhan, China
In person Yan has an answer for each accusation. Yes, he’d shipped fentanyl analogues and other compounds to the U.S., but that was before they became illegal in China, and he steered clear of others as they were banned. “I don’t know what they do with them after they get them,” he said. “They might abuse it. That’s one possibility.”
https://www.bloomberg.com/news/features/2019-12-03/merck-cyberattack-s-1-3-billion-question-was-it-an-act-of-war
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