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...Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration, this time for destroying current good manufacturing practice documents, among a list of other major violations...FDA sent a warning letter to the company following an eight-day inspection...of its Ankleshwar...manufacturing site that uncovered “torn and shredded equipment maintenance documents, raw material labels, and change control work orders” in the site’s scrap yard awaiting incineration...The site was banned from shipping products to the US in August...This is the latest in a series of failures by Wockhardt to meet the standards of not just FDA but other regulators...

A drug distributor owned by Cardinal Health Inc has agreed to pay $10 million to resolve claims it failed to alert the U.S. Drug Enforcement Administration to suspiciously large orders of...painkillers by New York-area pharmacies...The settlement with Kinray LLC, a New York City-based pharmaceutical distributor, disclosed in papers filed...in federal court in Manhattan...Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor's average sales of controlled substances to all of its customers...Kinray ignored numerous "red flags" and did not report any suspicious orders to the DEA...latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years...The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere...(Cardinal Health)...has set aside $44 million to cover those potential liabilities.

The Justice Department accused two executives of colluding with other generic pharmaceutical companies to fix prices, the first criminal charges stemming from a sweeping two-year investigation...Jeffrey Glazer, a former chief executive officer of Heritage Pharmaceuticals Inc., and Jason Malek, an ex-president...Each were charged in a criminal information with two counts of conspiring with other drug makers to fix the prices of an antibiotic and a drug used to treat diabetes (doxycycline and glyburide) . An information is often used as part of a plea agreement with prosecutors...Glazer and Malek accomplished this brazen theft by creating at least five dummy corporations, which they used to siphon off Heritage’s profits through numerous racketeering schemes," Heritage alleges. "Through one particularly audacious scheme...secretly arranged deeply discounted sales of Heritage products to their dummy corporations or through complicit third parties willing to act as straw buyers in return for bribes...Glazer and Malek then illicitly pocketed the profit that resulted when Heritage customers paid the market price for the drugs...The U.S. antitrust investigation spans more than a dozen companies and about two dozen drugs...

Five defendants pleaded guilty to federal charges for their roles in a drug ring that shipped crystal methamphetamine and oxycodone...Justin Lowe, Brandon Trivett, Lamar Skipper, Tanner Curd and Gary Childress, each pleaded guilty to one count of conspiring to distribute methamphetamine or oxycodone. Separately, Skipper pleaded guilty to one count of conspiring to commit money laundering. A federal investigation found that traffickers were shipping the drugs from Las Vegas to southwest Virginia and eastern Kentucky via package delivery companies like FedEx and the United States Parcel Service...The operation generated at least $1 million in drug proceeds and the money was transferred through bank accounts or wired...

Community pharmacist sentenced for dispensing the wrong medicine spoke of ‘cramped working’ conditions and problem of similar packaging...An “overworked” community pharmacist, who pleaded guilty to dispensing the wrong drug to a patient who later died, has been sentenced to four months imprisonment suspended for two years...Martin White of Belfast Road, Muckamore in Northern Ireland, mistakenly dispensed propranolol instead of prednisolone, having told investigators that the two packages were “side by side on the shelf and have similar branding”...White admitted at an earlier hearing...to an offence under section 64 of the Medicines Act 1968, that he had “supplied a medicinal product in pursuance of a prescription given by a practitioner, which was not of the nature or quality specified”, to the prejudice of Ethna Walsh...(her) death has had a devastating effect on her family and said the damage and injury caused by the pharmacist could not be higher...The pharmacist’s degree of culpability was the result of “poor professional performance, but not professional misconduct”...adding that there was “no evidence of intentional negligence”...given the cumulated effect of White’s guilty plea, previous good character, loss of reputation and career and permanent financial loss, (Judge Gordon Kerr) said he did not feel an immediate custodial sentence was necessary...

New drugs were appearing in the lab every other week, things never before seen in this unmarked gray building in Sterling, Virginia. Increasingly, these new compounds were synthetic opioids designed to mimic fentanyl...The fentanyl-like drugs are pouring in primarily from China...an assertion Beijing maintains has not been substantiated. Laws cannot keep pace with the speed of scientific innovation. As soon as one substance is banned, chemists synthesize slightly different, and technically legal, molecules and sell that substance online…Right now we're seeing the emergence of a new class - that's fentanyl-type opioids...Based on the structure, there can be many, many more substitutions on that molecule that we have not yet seen...Entrepreneurial chemists have been creating designer alternatives to cannabis, amphetamine, cocaine and Ecstasy for years. But this new class of synthetics is far more lethal...Today, it is almost as easy to order synthetic opioids on the open internet as it is to buy a pair of shoes...Payments can be made by Western Union, MoneyGram or Bitcoin, and products are shipped by DHL, UPS or EMS - the express mail service of China's state-run postal service. As the lines between licit and illicit commerce blurred, it became possible for just about anyone with internet access to score an ever-changing array of lethal chemicals...

Prosecutors have worked their way to the top of Insys Therapeutics. After arresting a series of lower-level workers, the Justice Department...hauled in former CEO Michael Babich…Federal authorities alleged that Babich and five other former Insys executives and managers “led a nationwide conspiracy” to bribe doctors to boost scripts for the company’s powerful and addictive painkiller Subsys...indictment...detailed a scheme that Babich and the others allegedly set up with 10 healthcare practitioners in Alabama, Michigan, Texas, Arkansas and elsewhere. The Insys execs pushed sales staff to offer hundreds of thousands of dollars in “bribes and kickbacks” to doctors to increase their Subsys scripts...According to the DOJ, Babich faces charges of conspiracy to commit racketeering, conspiracy to commit wire and mail fraud and conspiracy to violate the Anti-Kickback Law...

From a healthcare fraud enforcement perspective, 2016 was nothing short of a dynamic year...It was punctuated by the arrival of several important trends within the addiction treatment, post-acute care and compound pharmaceutical industries…It also featured a Supreme Court ruling on a False Claims Act legal theory, and a changing enforcement landscape in the aftermath of the Yates memo...As 2016 comes to a close, let's look back at some of the fraud trends that emerged—or in some cases intensified—over the last 12 months.

• Impact of the Yates memo
• Government targets post-acute care providers
• Big healthcare fraud busts continue
• Compound pharmacies under fire
• OxyContin marketing concerns revisited
• Addiction treatment gains ground, raises concerns
• Data continues to influence fraud detection
• EpiPen price hikes lead to overpayment settlement
• Medicare Advantage overbilling resurgence
• Supreme Court rules on implied certification

As drug prices have spiraled upward, tens of millions of generally law-abiding Americans have committed an illegal act in response: They have bought prescriptions medicines outside the U.S. and imported them...It's no secret that some Americans regularly buy prescription drugs on the Internet or while traveling abroad. But the popularity of the approach is underscored by the results of a Kaiser Family Foundation poll conducted in November...Eight percent of respondents said they or someone in their household had imported a drug at some point...The Kaiser poll queried a nationally representative sample of 1,202 adults...The Food and Drug Administration has cautioned that many online pharmacies aren't what they seem to be. An international crackdown in 2014 found that many packages of medicines purportedly from Australia, Canada, New Zealand and the U.K. contained drugs from other countries, including India, China and Laos...imported medications could be inferior or expired. Some could be counterfeits. But many medicines purchased from another country are the same as the ones patients buy in the U.S...When purchased outside the country, many prescription medicines cost half or less than they do in the U.S...it is generally illegal for Americans to import drugs into the U.S. for personal use. The law isn't rigorously enforced, in part, because it is difficult to monitor the entry of medicine in suitcases and small packages...in 2015 the FDA implemented a rule that would give government border inspectors expanded authority to destroy drugs imported for personal use at their point of entry.

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating, especially with the Internet providing an easy means for fraudsters to dispense their fakes. Counterfeiting has a devastating impact on public health and the economy. Not only are consumers paying for products of inferior quality, but their well-being is also put at risk. For genuine drugmakers, profits are diluted, but the repercussions extend beyond that...The European Union Intellectual Property Office reported...that the pharmaceutical industry is stripped of approximately €10 billion of revenue every year because of counterfeit medicines; this figure accounts for 4.4% of the sector’s sales...the lost sales translate into 37,700 jobs lost across the pharmaceutical sector in the EU as a result of legitimate manufacturers and distributors employing fewer people than they would do had this problem not existed…With serialization and track-and trace legislations being rolled out over the next few years, pharma is doing its part to secure its supply chain. The problem will be an ongoing challenge for the industry, but with advances in technology, it will become easier to detect the fakes in the near future.