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A former Insys Therapeutics Inc district sales manager was arrested...on charges he participated in a scheme to pay kickbacks to doctors to prescribe a drug containing the opioid fentanyl...Jeffrey Pearlman...was charged in a criminal complaint filed in federal court in New Haven, Connecticut, becoming the latest individual to face prosecution in connection with probes involving Insys' drug Subsys…The charges come as Insys faces a number of state and federal investigations involving Subsys as U.S. authorities seek to combat a national epidemic of opioid abuse...Prosecutors said Pearlman and sales representatives he managed induced doctors, advanced practice registered nurses and physicians' assistants to prescribe Insys' fentanyl spray by paying them to participate in sham "speaker programs."...As a result of the scheme, federal healthcare programs incurred millions of dollars in losses, prosecutors said...

The FDA’s Office of Criminal Investigations has spent thousands of hours pursuing foreign-imported, mislabeled drugs. But more than half of all OCI cases end without charges, and critics contend the agency’s efforts protect drug makers as much as consumers...On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic...West was chasing a lead that Dr. Anindya Sen...purchased an unapproved...cancer drug Avastin...Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging…A...judge later said West’s...statement about the drugs being counterfeit "apparently was not the truth." West’s search was declared illegal, and the evidence was deemed inadmissible…Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching…

The top law enforcement official in New Hampshire...accused the manufacturer of OxyContin...of stonewalling demands for information the company collects about suspected criminal trafficking of its painkiller..."They are just refusing to turn over documents," state Atty. Gen. Joseph Foster said of drugmaker Purdue Pharma..."On one hand, they tell us they have nothing to hide and they are doing everything appropriately, but then why are they fighting so hard not to turn over this information?"…In refusing to comply with the...subpoena, Purdue cited longstanding objections to the state’s use of a private law firm in an ongoing investigation of the company and other opioid makers…company lawyers have said Purdue is willing to provide records to the attorney general and his lawyers, but on the condition they not share them with the private attorneys, who they have suggested have a financial incentive to wrest multimillion-dollar judgments from the company in civil suits.

Illinois' attorney general...sued Insys Therapeutics Inc, accusing it of deceptively marketing and selling an addictive fentanyl-based medication, intended to treat cancer pain, to doctors for off-label uses...The lawsuit...comes as Insys faces a number of state and investigations involving its drug Subsys (fentanyl sublingual) as U.S. authorities seek to combat a national opioid abuse epidemic...This drug company's desire for increased profits led it to disregard patients' health and push addictive opioids for non-FDA approved purposes…the lawsuit seeks to bar Insys from selling its products in Illinois and impose financial penalties on the company...

A North Las Vegas doctor was arrested...in connection with a lewdness incident involving a patient...detectives arrested Jorge Burgos, 50, at his office in the 1800 block of East Lake Mead Boulevard on multiple counts of open and gross lewdness...Allegations were made that on multiple occasions, the doctor inappropriately touched a patient...Police said the investigation is ongoing, and they are seeking other possible victims...Burgos, an internal medicine physician, has no record of disciplinary actions by the Nevada State Board of Medical Examiners.

Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...

In March and April, 56 people in the Sacramento area were hospitalized after taking Norco brand hydrocodone pills. Fifteen died...But, as we discovered, these pills were not pharmaceutical hydrocodone at all. They were counterfeits containing fentanyl that were purchased on the street. Fentanyl is an opioid far more powerful than hydrocodone...the distribution of illicitly manufactured fentanyl has risen to unprecedented levels...These...substances are generally formulated to look like others drugs – heroin or oxycodone tablets…These entirely synthetic, illicitly made "designer drugs" are designed to work on the same receptors in the body as drugs like marijuana, methamphetamine or heroin. The adulteration of counterfeit pharmaceuticals and street drugs with synthetic opioids is arguably the most worrying new trend...

Healthcare organizations and manufacturers are very vulnerable when it comes to their data protection measures, according to the Intel Security 2016 Data Protection Benchmark Study...While the gap between data loss and breach discovery is increasing, healthcare organizations are “sitting ducks,”...the typical data loss prevention approach is increasingly ineffective against new theft targets...Not only is data getting outside of company control, it has probably been used or sold before the theft is noticed...Discovering and preventing breaches internally requires a better understanding of who is behind these thefts, what they are most likely to steal, how they are getting the data out, and the most effective steps to take to improve data loss prevention systems and processes...Healthcare is likely a top target because it holds desireable information - PHI and intellectual property. At the same time, healthcare typically has weaker systems that can be easier for hackers to access...

U.S. regulators said...that AstraZeneca will pay $5.52 million to resolve a foreign bribery probe into improper payments by its sales and marketing staff to state-employed healthcare officials in China and Russia...The U.S. Securities and Exchange Commission detailed the settlement with the London-based drug company in an order instituting an administrative proceeding arising out of violations of provisions in the Foreign Corrupt Practices Act...AstraZeneca, which cooperated with the probe, neither admitted nor denied wrongdoing…SEC said that AstraZeneca through at least 2010 failed to devise and maintain a system of internal accounting controls relating to its subsidiaries' interactions with Chinese and Russian government officials...Sales and marketing staff in those countries...provided gifts, conference support, travel, cash and other benefits to the state-employed healthcare providers to buy or prescribe the company's products...

The Nevada State Board of Medical Examiners has revoked the license of a physician accused of writing more than 600 fake prescriptions, providing more than 70,000 oxycodone pills for nonmedical purposes...Dr. Simmon Lee Wilcox, who practiced in Utah and Nevada, was found guilty of conspiracy to distribute the powerful pain-relieving drug and possession with intent to distribute a controlled substance...He was sentenced to 100 months — more than eight years — in federal prison and three years of supervised release...five others pleaded guilty to conspiracy to distribute oxycodone and said they conspired with Wilcox to use his license to provide the prescriptions, creating false identification documents to carry out the ruse…