- Testosterone Suits Soar Past 2,500 As Legal Milestone Looms For AbbVie (forbes.com)
…lawyers for AndroGel maker AbbVie will present their selection of 16 plaintiffs they’d like to represent the growing class of men who are suing the company over allegations that its product, a topical form of testosterone, caused blood clots, heart attacks and other adverse events. Lawyers representing the men will do the same in a process that will culminate in the selection of 12 “bellwether” cases to be tried starting late next year…men suing over testosterone has soared…to 2,744…Claims have been filed against seven makers of testosterone products…The court chose AbbVie as the subject of the first trials, with the first six bellwethers to involve men alleging “thromboembolic” injuries…and the second six alleging heart attacks or strokes...
- OPA announces opposition to marijuana oligopoly ballot initiative (ohiopharmacists.org)Ohio voters weigh legalizing recreational marijuana use (reuters.com)
Ohio Pharmacists Association, the state organization representing Ohio’s pharmacist practitioners, announced their opposition to the Ohio Marijuana Legalization Initiative, Issue 3, which if passed which would place legalized marijuana and a protected oligopoly of select commercial marijuana growers into the Ohio Constitution…OPA is unconvinced that marijuana is appropriate or beneficial as a form of treatment for illness or disease. Further, OPA rejects any medical marijuana proposal that removes the function, counsel, and expertise of the prescriber and pharmacist from the prescription process, as Issue 3 does…“If there is going to be a legitimate discussion about marijuana policy or the possible effectiveness of marijuana for medical purposes, then let’s have it. But ‘Responsible Ohio’ bypasses the discussion altogether in an effort to benefit to a few wealthy investors. Issue 3 is a slap in the face to Ohioans who genuinely care about sensible marijuana policy.”
- California doctor convicted of murder charges in overdose of patients (latimes.com)
A Rowland Heights doctor was convicted of second-degree murder…in connection with the overdose deaths of three patients, capping a landmark case that was closely watched by medical and legal professionals across the country…Dr. Hsiu-Ying “Lisa” Tseng, who prosecutors say is the first doctor convicted of murder in the United States for recklessly prescribing drugs to patients, was accused of ignoring “red flags” about her prescribing habits, including the overdose of a patient in her clinic and nine phone calls in less than three years from authorities informing her that patients had died with drugs in their system…. Tseng was one of only a handful of doctors across the country who have faced murder charges for prescribing painkillers that led to a patient's death...
- Why the FDA Is Worried About Chinese Drugs in Your Medicine Cabinet (bloomberg.com)
U.S. Food and Drug Administration inspectors at Zhejiang Hisun Pharmaceutical Co….according to agency documents describing problems at the company...There was evidence that quality control staff deleted records of tests that might show a drug was impure. Audit trails disappeared. A paper shredder was kept close by machines that recorded quality data…U.S. and the rest of the world are more dependent than ever on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world…the FDA has made inspections there a priority to keep patients safe. It’s found plenty -- the agency has barred 38 plants in China from exporting some or all of their products to the U.S. for manufacturing violations. And 34 facilities are banned from exporting a blood thinning ingredient, after a past scandal, according to the FDA’s import alert list.
- FTC raises anticompetitive concerns about FDA naming proposal for biosimilars (pharmalot.com)Nonproprietary Naming of Biological Products Guidance for Industry DRAFT GUIDANCE (fda.gov)In Response to a Request for Comments on Its Guidance for Industry on the “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability” (ftc.gov)
What’s in a name?..A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits…At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine…
- 6 Southern Nevada hospitals included in paying $250M settlement (reviewjournal.com)
Six Southern Nevada hospitals are among hundreds of U.S. facilities (457 hospitals in 43 states) that will pay a total of more than $250 million stemming from allegations that they implanted cardiac devices in Medicare patients in violation of coverage requirements, the U.S. Justice Department said…Medicare guidelines provide that doctors should not implant ICDs (implantable cardioverter defibrillator) in patients who have recently suffered a heart attack or had other procedures, such as heart bypass surgery. Each of the hospitals…had implanted ICDs during 40 day waiting periods that Medicaid requires for heart attack patients and 90 day waiting periods for bypass patients…Las Vegas-area hospitals involved include Centennial Hills, Desert Springs, Summerlin, Valley, Sunrise, and North Vista...
- WBA to divest as many as 1,000 stores to secure Rite Aid deal approval (drugstorenews.com)
The merger agreement between Walgreens Boots Alliance and Rite Aid must be consummated by Oct. 27, 2016, or the deal is off, according to documents filed to the Securities and Exchange Commission on Thursday…If Rite Aid walks away from the deal at any time, Rite Aid will forfeit a $325 million termination fee to Walgreens. Rite Aid may also be required to pay up to an additional $45 million to cover expenses incurred by Walgreens…Conversely, Walgreens will forfeit $325 million to Rite Aid if it's not able to secure regulatory approval of the deal, a figure that could double to $650 million if Walgreens "enters into, consummates or announces certain acquisitions within eight to 12 months of the date of the merger agreement…Walgreens is willing to divest as many as 1,000 locations, or other holdings not to exceed an aggregate value of $100 million, in an effort to secure approval of the acquisition..
- Warner Chilcott Agrees to Plead Guilty to Felony Health Care Fraud Scheme and Pay $125 Million to Resolve Criminal Liability and False Claims Act Allegations (justice.gov)
Warner Chilcott U.S. Sales LLC, a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, has agreed to plead guilty to a felony charge of health care fraud, the Justice Department announced...The plea agreement is part of a global settlement with the United States in which Warner Chilcott has agreed to pay $125 million to resolve its criminal and civil liability arising from the company’s illegal marketing of the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace and Loestrin…company committed a felony violation by paying kickbacks to physicians throughout the United States to induce them to prescribe its drugs, manipulating prior authorizations to induce insurance companies to pay for prescriptions of Atelvia that the insurers may not have otherwise paid for and making unsubstantiated marketing claims for the drug Actonel…As part of today’s resolution, the whistleblowers will receive approximately $22.9 million from the federal share of the civil recovery.
- Pharmacist at center of Valeant scandal accuses drugmaker of ‘massive fraud’ (latimes.com)
..pharmacist Russell Reitz…agreed to sell his pharmacy (R&O Pharmacy), in a quiet suburban office park, to the group (East Coast investors) for $350,000…he continued as manager, Reitz began finding his store's name and his national pharmacy license number on an avalanche of prescriptions nationwide…a torrent of insurers' money started flowing to his small shop…on pace to equal $230 million a year…Reitz now finds himself at the center of the national scandal enveloping Valeant…In the last two months, Reitz has filed papers in two Los Angeles courthouses laying out details of what he and his lawyer call "a massive fraud."…Until Reitz's court filings…few people knew about Valeant's close ties to Philidor...Reitz detailed how he had discovered that Philidor was using his national pharmacy identification number on prescriptions being filled at other pharmacies — and even on some that were filled and billed before he signed the agreement to sell R&O…Reitz said he believes that Philidor had targeted his pharmacy because it needed access to his licenses, which he has in California and 33 other states, as well as to the contracts he had negotiated with insurers.
- New York Pharmacist and Two Others Face Criminal and Civil Charges for Multimillion-Dollar Oxycodone Distribution Scheme (dea.gov)
Drug Enforcement Administration…announced...an indictment today against three individuals and two pharmacies for a multimillion-dollar oxycodone distribution scheme…through pharmacies operated in Brooklyn and Queens. Lilian Jakacki, Marcin Jakacki, Robert Cybulski, European Apothecary Inc, Chopin Chemists, MW&W Global Enterprises Inc…charged with illegally distributing more than 500,000 pills of oxycodone...with a street value between $10 million and $15 million. The defendants are also charged with money laundering and health care fraud…one of the largest illegal diversions of oxycodone…in a New York State pharmacy. Pharmacies also illegally diverted more than 160,000 additional pills by accepting 1,300 fraudulent prescriptions…including prescriptions made out in the names of famous luxury brands such as “Coach” or “Chanel.”









