- Compounding pharmacies investigated for possible fraud tied to pain creams (healthcarefinancenews.com)
The Department of Justice is investigating potential fraudulent claims and billing linked to specialty creams...that claimed to treat pain symptoms...investigators have claimed many of these specialty creams have little or no medicinal value...the issue is with the alleged false claims, not the compounds themselves...It's part of a larger issue of healthcare fraud...All these people submitting claims … for drugs that have absolutely no effectiveness. Are they doing it with knowledge, and seeking reimbursement for it? It's the modern day snake oil salesman...the International Academy of Compounding Pharmacies said the creams in question "benefit people and are non-addictive."...No charges have been filed...
- U.S. charges drug researchers with sending trade secrets to China, but will case stand up? (sciencemag.org)Scientists Indicted For Allegedly Stealing Biopharmaceutical Trade Secrets (justice.gov)
Attorneys are urging caution in evaluating the strength of a U.S. trade secrets case against two GlaxoSmithKline scientists who were accused last week of transferring trade secrets to China. The case bears some similarities, they say, to other recent cases involving Chinese American or Chinese defendants in which federal prosecutors abruptly dropped charges because of improper analysis or insufficient evidence...Last week, federal prosecutors in Philadelphia...announced the indictments of biomedical researchers Yu Xue and Lucy Xi, as well as three associates, for trade secrets theft, wire fraud, and other charges. The scientists stand accused of emailing and downloading proprietary data about GSK products and sending it to contacts working for the Chinese startup Renopharma, which provides contract research services for early drug discovery...The case comes on the heels of several high-profile investigations into Chinese or Chinese American scientists in which prosecutors have abruptly dropped charges, sparking accusations of racial profiling. This past September, prosecutors dropped charges against Xiaoxing Xi, the interim chair of Temple University’s physics department, after experts submitted affidavits suggesting that his alleged crimes were merely standard scientific collaborations.
- AG calls on Gilead to lower price of hepatitis C medicines (bostonglobe.com)Does it break the law to charge a lot for a cure? (theincidentaleconomist.com)
Massachusetts Attorney General...opening a new front in the push to boost access to life-saving drugs, has warned the country’s biggest biotech company that it faces possible legal action unless it lowers the price of two popular hepatitis C medicines...In a letter to Gilead Sciences Inc., made public Wednesday, the attorney general wrote that the high price of the company’s Sovaldi drug, which costs $84,000 for a full 12-week course of treatment, and its Harvoni regimen, at $94,500, "may constitute an unfair trade practice in violation of Massachusetts law" because they are too expensive for many patients...While other state attorneys general have sued drug makers seeking larger Medicaid rebates or discounts, her office is believed to be the first to consider using a state consumer protection law to charge a company with overpricing its products...
- China ingredient maker’s plant found in ‘devastated state’ by authorities (fiercepharmamanufacturing.com)
China, which manufactures most of the ingredients for Western products, has a reputation for having some pretty questionable manufacturing operations. Czech inspectors got a firsthand look at one plant that they said posed "extreme risks" to consumers...According to two reports on the plant posted by the European Medicines Agency, authorities dropped by the Huanggang City facility of Hubei Hongyuan Pharmaceutical in October after the plant had been mentioned as an intermediate manufacturing site for the antibiotic metronidazole. The company acknowledged in its introduction that the site didn't follow EU GMP standards, the report says. During a walk-through, inspectors confirmed that...They said they found a plant in a devastated state, with "huge layers of dust and product" that indicated that neither the plant nor the equipment was being cleaned or that equipment was being maintained. It was noted the situation posed "an extreme risk of cross-contamination." Additionally, almost none of the products that they saw had been labeled and there was no batch manufacturing documentation...Western authorities have stepped up inspections of Chinese plants, both of those owned by Chinese companies and those owned by Western drugmakers, and found problems in both cases.
- Doctor gets 30 years to life for prescription drug deaths (statnews.com)
A Los Angeles-area doctor convicted of murder for prescribing exorbitant amounts of painkillers that left a dozen patients dead was sentenced...to 30 years to life in prison...The conviction of Dr. Hsiu-Ying "Lisa" Tseng and her long prison sentence are rare for a doctor...Minutes before she was sentenced, Tseng apologized in court to the families of her dead patients and others who became addicted to prescription drugs under her care...In handing down the harsh sentence, Los Angeles County Superior Court Judge George Lomeli said he found it egregious that Tseng continued to write reckless prescriptions even after learning her patients were dying..."(She’s) a person who seemingly did not care about the lives of her patients in this case but rather appeared more concerned about distributing dangerous controlled substances in an assembly line fashion so as to collect payments which amounted to her amassing several million dollars," Lomeli said...
- China fines 5 companies for monopoly on drug sales (fiercepharmaasia.com)
China's National Development and Reform Commission has imposed fines totaling $608,000 on 5 mainland drugmakers and distributors for price-fixing of allopurinol, which is considered an essential medicine in China and is widely used to treat gout and hyperuricemia...The NDRC fined drugmakers Chongqing Qingyang, Jiangsu Shimaotianjie, and Shanghai Xinyi, which have been the only three domestic producers of the tablets since 2014, according to the reports. They also fined distributors Chongqing Datong and Shangqiu Huajie..."Five companies have been fined for colluding to manipulate pricing and dividing the market of a common tablet," said...deputy inspector of the Price Supervision and Anti-Monopoly Bureau..."Even though the fine is not the largest issued since the NDRC began bringing actions against pricing collusion, it is significant."
- Feds tell judge Martin Shkreli can go to Washington to testify before Congress (statnews.com)
Martin Shkreli appears to be a big step closer to testifying before a congressional committee...US Department of Justice wrote a letter Sunday to a federal judge overseeing a securities fraud case against Shkreli to say “the government does not object to (Shkreli) traveling to Washington, D.C., to comply with the House Committee’s subpoena” to testify at a hearing on prescription drug pricing. As part of his $5 million bail order, Shkreli is prevented from traveling outside parts of New York City and nearby Long Island...The letter paves the way for Shkreli to appear before the House Oversight and Government Reform Committee, which wants to explore the rising cost of medicines. A hearing had been scheduled for Tuesday, but it has been postponed to Feb. 4 due to the recent blizzard.
- FBI, DEA Release Documentary Film Addressing Heroin/Prescription Drug Abuse (dea.gov)
In an effort to combat the growing epidemic of prescription drug and heroin abuse, leaders of the FBI and DEA today unveiled a documentary aimed at educating students and young adults about the dangers of the addiction. "Chasing the Dragon" is a 45-minute documentary film that profiles the stories of several people who either abused opiates or had family members become addicts. It profiles the cycle of addiction and looks at the tragic consequences associated with opioid abuse. The documentary also features interviews with medical and law enforcement professionals discussing the effects of the addiction, and how this epidemic is unlike any this country has seen before...(Chasing the Dragon: The Life of an Opiate Addict - downloadable here)...
- Surgeon Receives 78 Months in Prison for Distributing Oxycodone (dea.gov)
Jeffrey Gundel...an orthopedic surgeon from Gansevoort, New York, was sentenced today to 78 months in prison for illegally authorizing the distribution of tens of thousands of oxycodone pills...Gundel pleaded guilty to one count of unlawful distribution of oxycodone...admitted that...he wrote over 200 prescriptions authorizing the dispensation of at least 59,520 30-milligram oxycodone tablets for no legitimate medical purpose. Gundel also admitted that he received cash kickbacks after co-conspirators filled the prescriptions and sold the oxycodone pills on the black market...
- Licorice Coughing Liquid Recall, Presence of Morphine (infozine.com)Master Herbs, Inc. Issues Voluntary Nationwide Recall of All Lots of Licorice Coughing Liquid Due to the Presence of Morphine (fda.gov)
Master Herbs, Inc. (Ma Ying Long Pharmaceutical Group) is voluntarily recalling ALL LOTS of Licorice Coughing Liquid, cough syrup in 100 ml bottles to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label. Opioid is an ingredient of Compound Camphor. Compound Camphor is declared on the label of the product, but not its ingredients...The product is used for the temporary relief of cough due to cold, minor throat and bronchial irritations...identified by the Chinese Product Name: Licorice Coughing Liquid The product was distributed to Chinese grocery stores in various cities in California, New Jersey, Hawaii, Illinois, Ohio and Nevada.