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Food and Drug Administration Commissioner Scott Gottlieb said he's putting pharmacy chain Walgreens "on notice" for allegedly selling tobacco products to minors...The agency has already filed formal complaints seeking to block a Walgreens' location in Miami and a Circle K Store in Charleston, South Carolina, from selling cigarettes or cigars for 30 days, citing "repeated violations."...Walgreens, the FDA noted, is currently the top violator among pharmacies that sell tobacco products. Some 22 percent of Walgreens locations inspected by the agency caught employees illegally selling tobacco products to minors...

The Chinese API maker at the heart of a global scare and recall of blood pressure medicines has been savaged in an FDA warning letter for failing to uncover a suspected carcinogen in its APIs when a customer complained several years ago...The FDA said that when Zhejiang Huahai Pharmaceutical altered its manufacturing process in 2011 to include a solvent suspected of producing the impurity, it didn’t even consider that the changes might lead to the formation of mutagenic impurities in its valsartan APIs...“You failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process,” the highly redacted warning letter says...Regulators in the U.S. and Europe continue to test products to try to ferret out all of the affected drugs. The FDA says there is very little risk of the impurities causing problems, and no adverse reactions have been seen...

An Elko cardiologist has pleaded guilty to distributing highly-addictive prescription drugs...to patients without a medical purpose...59-year-old Dr. Devendra I. Patel...who owns and operates Northeastern Nevada Cardiology, was indicted by a grand jury in December 2017...The investigation showed Patel illegally prescribed opioids and other prescription narcotics to patients for financial gain. As part of his plea, Patel admitted that, between September 2015 and February 2016, he prescribed Oxycodone and Hydrocodone to patients without a legitimate medical purpose and outside the usual course of professional practice...The statutory maximum penalty is 20 years in prison and a $1,000,000 fine.

The expansion of Medicaid in Nevada in 2014 made mental health care much more widely available in a state ranked last in the nation for access to such services. It also provided a great opportunity for bad actors...catching those who abuse the Medicaid system is a tortuous process that can either come too late or result in relatively minor penalties...fraudsters are undoubtedly adding to the $56 million deficit Nevada Medicaid predicts it will face in the 2019 fiscal year, up from last year’s $30 million forecast at this time...The Medicaid expansion has certainly “exacerbated” the problem of fraudulent or improper claims in the field of behavioral health...Suspicious claims from mental health providers led Nevada Medicaid to investigate $73 million paid out in the 2018 fiscal year...So far, about $10 million — or 13 percent — has been recovered...

An ex-stripper who became a regional sales director at Insys Therapeutics Inc gave a doctor a lap dance at a Chicago club as the drugmaker pushed the doctor to prescribe its addictive fentanyl spray, a former Insys employee testified...The testimony in federal court...came in the first criminal trial of painkiller manufacturer executives over conduct that authorities say contributed to a U.S. opioid abuse epidemic... Former Insys sales representative Holly Brown told jurors the incident with her boss, Sunrise Lee, took place after Insys began rewarding the doctor for prescribing its opioid product by paying him to speak at educational events about the drug...That Illinois doctor, Paul Madison, is one of several whom prosecutors say Lee and four other former Insys executives and managers including wealthy founder and ex-chairman John Kapoor conspired to bribe to boost sales of the spray, Subsys

The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity...Actelion...makes expensive drugs to treat a rare lung condition, is the latest pharmaceutical company to settle federal inquiries into their ties to patient-assistance groups, including whether companies have used the patient programs to increase the price of their drugs...But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization...Federal prosecutors said Actelion violated the law by collecting detailed data in 2014 and 2015 about the patients receiving help from a nonprofit, the Caring Voice Coalition, and using the data to budget for future donations. As a result, Actelion ensured that the money it donated would be used only to assist patients who used its drugs, and not competing companies’ treatments for the pulmonary condition.

A day after President Trump signed a massive piece of legislation responding to the opioid crisis into law, the Department of Justice announced it's pouring even more resources into its crackdown on prescribers...Attorney General Jeff Sessions said his agency was creating a new Appalachian Regional Prescription Opioid Strike Force to focus on communities "hit especially hard by addiction and opioid fraud."...a dozen prosecutors and data analysts will operate out of hubs in Cincinnati/Northern Kentucky and Nashville, Tennessee, monitoring the Appalachian region for fraudulent opioid prescriptions by physicians...

Walgreens Boots Alliance Inc will pay $269.2 million to settle two whistleblower lawsuits accusing it of civil fraud for overbilling federal healthcare programs over a decade, the U.S. Department of Justice said...The pharmacy chain will pay $209.2 million to resolve claims it improperly billed Medicare, Medicaid and other federal programs from 2006 to 2017 for hundreds of thousands of insulin pens it dispensed to patients it knew did not need them...Walgreens will also pay $60 million to resolve claims it overcharged Medicaid from 2008 to 2017 by failing to disclose and charge the discount drug prices it offered the public through its Prescription Savings Club program...Two pharmacists filed the original complaint concerning the insulin pens in July 2015. A copy of that complaint could not immediately be obtained on Tuesday...Marc Baker, who worked for Walgreens for a decade as a pharmacy manager in Florida, filed the original complaint concerning the drug price discounts in January 2012.

Six Michigan doctors have been charged with insurance fraud and unnecessarily prescribing opioids to patients in a $464 million scheme, according to court documents...The 56-count indictment...named Dr. Rajendra Bothra...who owned and operated the Pain Center USA in Warren and Eastpointe, Mich., and the Interventional Pain Center in Warren. The other five doctors were employed by the clinics, which catered to patients with joint and spinal injuries...The doctors have been charged with submitting false claims...and diverting the proceeds to themselves...Prosecutors said the doctors submitted claims of $182.5 million to Medicare, $272.6 million to Medicaid and $9.2 million to Blue Cross Blue Shield of Michigan...

European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said...the latest crackdown on the Chinese firm after a probable carcinogen was found in its blood pressure drug valsartan...EU authorities will now supervise the manufacture of other active substances produced by Zhejiang Huahai more closely...European authorities said late last month they had found that Huahai did not comply with good manufacturing practices and that the company’s factory in Linhai, China, was no longer authorized to produce valsartan...European and North American regulators last month found a second toxin in Valsartan that may cause cancer in humans...low levels of a carcinogen have now also been found in irbesartan made by Aurobindo Pharma, with the supply in the EU...being suspended.