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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...

Novartis’ Sandoz unit has been marketing Zarxio, its biosimilar version of Amgen’s blockbuster drug Neupogen, for more than a year, but the drug is still tangled in a patent fight that boils down to one central question: Should biosimilar makers have to give six months' notice to the original drugmaker after they receive FDA approval for their copycat version? The answer will affect not only Novartis and Amgen, but any company seeking to make a biosimilar product…The U.S. Solicitor General...asked the Supreme Court to interpret the 2009 law that originally laid out the proper procedure for seeking FDA approval for biosimilar drugs.

FDA recently approved the first biosimilars for adalimumab (Humira—AbbVie) and etanercept (Enbrel—Amgen), known as adalimumab-atto (Amjevita—Amgen) and etanercept-szzs (Erelzi—Sandoz), respectively. These approvals came after unanimous votes of support by FDA’s Arthritis Advisory Committee in July. Unfortunately, the launch of both biosimilar products will be delayed because the manufacturers of the reference products are involved in litigation against biosimilar manufacturers for patent infringement...A recent meta-analysis...suggest these products have nearly identical pharmacokinetics, efficacy, and toxicity…Although the trials cited by this meta-analysis involved limited numbers of patients, there is no reason to suspect these biosimilars will not be nearly identical to their reference product...

Teva is trying to clean the slate on its history of allegedly paying bribes in foreign countries to boost sales. Having revamped its governance programs and set a new tone about bad behavior, it has now put aside more than half a million dollars to cover anticipated settlements with U.S. authorities...Teva revealed it was in “advanced discussions” to settle investigations by the Justice Department and SEC into violations of the Foreign Corrupt Practices Act and set aside about $520 million to cover the expected settlements. It said those discussions concern matters that occurred in 2007-2013 in Russia, Mexico and Ukraine...Teva emphasized that none of the conduct involved its U.S. business, inferring instead that it was problems with third parties and subsidiaries. It pledged to do whatever it can to prevent a repeat...The compliance program that Teva has in place now is serious, rigorous, and comprehensive and is designed to protect the company and its subsidiaries against future violations…

Drugmaker Bristol-Myers Squibb Co will pay $19.5 million to resolve multi-state allegations that it improperly promoted a schizophrenia treatment for uses not approved by the U.S. government, New York Attorney General Eric Schneiderman said...The company's agreement with 42 other states and the District of Columbia centers on charges that Bristol-Myers Squibb promoted its Abilify anti-psychotic drug for use in children and elderly patients with dementia and Alzheimer's disease...Besides addressing the off-label promotion allegations, the settlement also resolves charges that the company violated state consumer protection laws by misrepresenting side effects such as metabolic weight gain.

Nevada is expected to receive nearly $300,000 in a multistate settlement with a pharmaceutical company accused of marketing a drug to patient groups for which they didn’t have federal approval and mischaracterizing the drug’s risks...Bristol-Myers Squibb Company, which partnered with Otsuka America Pharmaceutical, Inc. to market antipsychotic drug Abilify, settled with 43 states for $19.5 million, according to an announcement Thursday by the office of Nevada Attorney General Adam Laxalt...The company was accused of marketing the drug to seniors with Alzheimer’s disease and dementia despite the fact the drug wasn’t approved for those purposes by the U.S. Food and Drug Administration...

In the latest struggle over pharmaceutical costs, Pfizer has filed a lawsuit against a Texas state agency for releasing Medicaid rebate data to a pair of state lawmakers, claiming the move violated federal and state laws that protect its confidential information...By releasing the data, Pfizer argued the Texas Health and Human Services Commission compromised “valuable and commercially sensitive trade secrets” that could hurt its ability to compete with rivals, according to the lawsuit…The drug maker...contended that disclosure can lead to “uniform pricing” that could harm Medicaid. How so? Pfizer maintained that, if other large purchasers were to know about — and then demand — the same prices offered to the Texas Medicaid program, the company “would not be able to provide such pricing and rebates to every entity due to their unique differences in size, market and particular needs.”...the cat is out of the bag, Pfizer asked the court for a temporary restraining order and a preliminary injunction to prevent the Texas Health and Human Services Commission from releasing data in response to any additional requests...This is likely to be a closely watched case, given the tremendous interest in pharmaceutical costs and the mystery surrounding rebates.

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...

As the generic drug industry braces for charges from a two-year U.S. Justice Department antitrust investigation, a union representing the sergeants of the New York Police Department is attempting to hit some companies with civil penalties as well...A pair of lawsuits filed by the Sergeants Benevolent Association Health & Welfare Fund against two groups of drugmakers, which include...Novartis AG’s generic drug unit,...Perrigo Co., India’s Wockhardt Ltd. and Taro Pharmaceutical Industries Ltd., allege the companies colluded to raise prices on two dermatological creams as much as 1,000 percent…U.S. pharma sector is now facing sharp scrutiny on pricing, including a sweeping Justice Department probe. That antitrust investigation spanning companies from around the world is examining whether some executives agreed with one another to raise prices on generic medicines in the U.S...

One day before Walgreens Boots Alliance severed its relationship with the blood-testing laboratory Theranos in June 2016, Theranos acknowledged to Walgreens executives that more than 10% of the test reports —  totaling 31,000 test reports altogether —  that were provided to Walgreens customers who used Theranos' services had to be voided. "[Theranos] stated that 31,000 Walgreens customers had received voided test reports, which was 11.3% of total Walgreens customers," Walgreens alleged in court papers filed Tuesday...According to Walgreens, Theranos broke each of the promises made to the Chicago-based retail pharmacy operator, which had entered into an exclusive arrangement with Theranos in July, 2010, and which was later amended in June, 2012. The 2012 agreement provided the framework under which Theranos Wellness Centers could operate inside Walgreens' stores...