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It turns out that the quarter-crushing $575 million that drug wholesaler AmerisourceBergen set aside to settle civil litigation with the Justice Department was not enough. It is going to take another $50 million...That comes on top of the $260 million the drug distributor has already paid to resolve a criminal misdemeanor charge tied to its sales of injected cancer meds produced in a plant that was not FDA certified...the company has now agreed to pay $885 million to resolve both civil and criminal allegations which are tied to issues that reach back more than 15 years...The company...in a filing reported it increased its Q4 set aside to $625 million to cover the agreement, which is awaiting court approval...The civil case stemmed from alleged violations of the federal False Claims Act. The DOJ has alleged that between 2001 and 2014 two of the wholesaler’s...subsidiaries—Oncology Supply Co. and the now-defunct Medical Initiatives—prepared millions of syringes of cancer medicines, including Aloxi and Anzemet and generics of Neupogen and Procrit, in an unapproved facility...the complaint did not indicate any patients were harmed by the drugs and that FDA testing of syringes that were seized in the case had not found any “quality concerns.”

Connecticut Attorney General George Jepsen, who is leading a coalition of states suing generic drugmakers, told CNBC..."We've uncovered through emails, text messages and telephone patterns, plus cooperating witnesses, a very compelling case of systematic and pervasive price fixing within the industry,"...45 states, including Connecticut, as well as the District of Columbia and Puerto Rico moved to expand their lawsuit to 18 companies and 15 medicines. The suit also names two individual executives, including Rajiv Malik, president (of)...Mylan...The original complaint, filed in December, had focused on six companies and two medicines...

A Texas judge invalidated Allergan patents on its dry eye medicine Restasis on the grounds that the patents cover obvious ideas...Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drugmakers led by Mylan NV and Teva Pharmaceutical Industries Ltd...The ruling could enable the generic drug companies to sell their own versions of Restasis, which generated around $1.5 billion in sales for Allergan last year and accounted for more than 10 percent of the company's revenue...Allergan's stock price dropped about 5 percent on the news...The patents at issue were the same ones Allergan transferred to a Native American tribe in an effort to protect them from administrative review...

Last month, drugmaker Allergan announced that it has made a deal with a New York state American Indian tribe to help protect Restasis from competition, using the tribe’s sovereign immunity as a shield against patent challenges. The deal—the first such move by Allergan and, in the pharmaceutical industry, an unusual one at best—has unleashed a firestorm of criticism, including from lawmakers...Originally, patents on Restasis were set to expire in 2014. But Allergan filed more patents, covering the “specific formulation and the method of using” the product, that expire in 2024...Lawmakers and patient advocates, meanwhile, are concerned not only about the implications for Restasis but whether this will set a pharmaceutical industry precedent...The House Oversight committee wrote to Allergan Chief Executive Brent Saunders on Tuesday asking for documents and information regarding the deal...The agreement “may impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs,” according to the letter...Allergan said in a statement that it plans to comply with the information requests...patient advocates say they’re worried...Allergan’s sham patent transfer is an effort to circumvent the law to prevent a cheaper generic of Restasis to come to market,” said David Mitchell, the co-founder and president of the non-profit Patients for Affordable Drugs. “Patients will be hurt by this. Patients are being hurt by this. And it’s an outrage.”

Fentanyl billionaire John Kapoor is set to plead not guilty this morning on charges of racketeering, mail fraud, wire fraud and conspiracy to violate the anti-kickback law...The founder and former CEO and chairman of ...Insys Therapeutics, Kapoor became a billionaire in 2013 because of the skyrocketing sales of that company’s Subsys, a form of the powerful opioid fentanyl that is sprayed under the tongue. He was arrested and charged on October 26 for allegedly leading a conspiracy to use fraud and bribes to market the drug and is set to appear in federal court in Boston...for his arraignment...Prosecutors...allege that Kapoor and six other executives...were arrested and charged...as part of a superseding indictment, offered bribes and kickbacks to doctors and nurses to get them to write large numbers of Subsys subscriptions to patients, most of whom did not have cancer.

A federal judge...denied a request by pharmaceutical companies to immediately block a Nevada law requiring them to detail diabetes drug prices and disclose manufacturing costs and research investments come July...The reason, he said: July is more than nine months away...“I don’t see immediate and irreparable harm here,” U.S. District Judge James Mahan said after hearing arguments for and against the request in Las Vegas. Mahan said he might reconsider if the request were made in March or April, but he facetiously added, “My crystal ball is broken.”...At Tuesday’s hearing, Robert Weiner, who represented the pharmaceutical groups, argued that acts as a penalty for companies wanting to raise prices after Nov. 1 and before the July disclosure date...“This is a competitive disadvantage, and it chills us now,” Weiner said...Arguing against the injunction, Las Vegas Chief Deputy Attorney General Linda Anderson said the law is intended to protect diabetes patients in Nevada.

J&J won the reversal of a verdict in favor of the family of a woman whose death...stemmed from her use of the company's talc-based products...J&J, which won one Missouri trial, says it faces lawsuits by 4,800 plaintiffs nationally asserting similar claims over its talc-based products...It also faces cases in California, where in August a jury awarded a woman $417 million...Johnson & Johnson...won the reversal of a $72 million verdict in favor of the family of a woman whose death from ovarian cancer they claimed stemmed from her use of the company's talc-based products like Johnson's Baby Powder...The Missouri Court of Appeals for the Eastern District said that given a recent U.S. Supreme Court decision that limited where injury lawsuits could be filed, the case over Alabama resident Jacqueline Fox's death should not have been tried in St. Louis.

A large group of U.S. states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving...to widen an earlier lawsuit to add many more drugmakers and medicines in an action that sent some company shares tumbling...The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals...The states said the drugmakers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases in advance...“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case...The...Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe

Pharma companies have faced a gamut of allegations over the years, but a new lawsuit ups the ante by alleging several drugmakers paid bribes in Iraq that helped fuel terrorism...the lawsuit alleged that top pharma companies Pfizer, Roche, Johnson & Johnson and AstraZeneca paid bribes to secure healthcare contracts in Iraq. Those payments ultimately supported terrorism that hurt or killed U.S. service members...More than 100 veterans or their family members are suing the drugmakers under the Anti-Terrorism Act...The lawsuit said the "terrorist-finance mechanism was straightforward: the terrorists openly controlled the Iraqi ministry in charge of importing medical goods, and defendants—all of which are large Western medical-supply companies—obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."

Shire filed a lawsuit in a federal court against Allergan, claiming anticompetitive practices in its reimbursement contracts with payers on the eye drug Restasis. It's the latest in a series of similar cases, and the verdicts could well upturn all pharma-payer negotiations...Shire makes a rival product, Xiidra, and its fight against Allergan challenges longstanding negotiation practices that many makers of follow-on products argue are stifling competition...The verdicts in these cases could well rewrite the rules that govern how drugmakers form contracts with payers...Any verdicts in favor of the antitrust arguments could make it easier for manufacturers of biosimilars and other products entering well-established markets to steal share from the incumbents...In Shire's case, it’s arguing that Allergan improperly entered into exclusive contracts for Restasis with Medicare Part D providers. Those exclusive deals prevent makers of rival dry-eye remedies from competing for patients, the suit said...