- Supreme Court rejects pharmacists’ religious claim (reuters.com)
A divided U.S. Supreme Court...rejected an appeal filed by pharmacists in Washington state who objected on religious grounds to providing emergency contraceptives to women...The justices, with three conservatives dissenting, left in place a July ruling by the San Francisco-based 9th U.S. Circuit Court of Appeals that upheld a state regulation that requires pharmacies to deliver all prescribed medicines in a timely manner...In Washington, the state permits a religiously objecting individual pharmacist to deny medicine, as long as another pharmacist working at the location provides timely delivery. The rules require a pharmacy to deliver all medicine, even if the owner objects...Alito said there is evidence the regulation was adopted because of "hostility to pharmacists whose religious beliefs regarding abortion and contraception are out of step with prevailing opinion in the state."..."If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern," Alito added.
- Drug makers pay $67 million for misleading docs about cancer drug survival data (statnews.com)
Two drug makers — Roche’s Genentech and OSI Pharmaceuticals — announced a deal...to pay $67 million to resolve charges they made misleading statements about the effectiveness of the Tarceva drug to treat non-small cell lung cancer...between 2006 and 2011, the companies gave promotional materials to oncologists that included misleading and overstated survival data to influence prescribing. The drug was originally approved by the US Food and Drug Administration as a second-line or back-up treatment, but the inflated data prompted some doctors to use Tarceva as a first choice, which boosted usage...the feds contend the companies violated the False Claims Act, because federal health care programs, such as Medicare and Medicaid, overpaid for the medicine…The infractions came to light thanks to a whistleblower lawsuit that was filed by Brian Shields, a former Tarceva senior product manager. His 2011 lawsuit described an elaborate scheme that was used to bolster Tarceva prescriptions, including kickbacks purportedly paid to physicians...
- Washington state told to lift restrictions on hepatitis C medicines (statnews.com)
The Washington state Medicaid program has been ordered to lift restrictions on coverage of pricey hepatitis C treatments, according to a preliminary injunction issued...by a federal judge...The ruling came in response to a lawsuit filed by state residents who claim the drugs are "medically necessary," and that the decision by the Washington State Health Care Authority to provide coverage to only the sickest patients had caused them harm...In a strongly worded...opinion, United States District Court Judge John Coughenour agreed with their argument. He wrote that the facts "clearly favor" their contention that state policy violates federal law. In his view, the evidence "establishes that there is a consensus among medical experts and providers that the life-saving [drugs] are medically necessary" for all hepatitis C patients...This is the first time a federal court has declared that widespread restrictions across a state Medicaid program is illegal for hepatitis C medicines...The opinion is only the latest instance in which a public or private insurer has been forced to reconsider its coverage policies toward hepatitis C medicines, which helped trigger a wave of controversy over the cost of prescription drugs...
- Dr. Robert Rand does not enter plea during Reno federal court appearance (mynews4.com)Reno prescription drug ring case: What we know now (rgj.com)
Dr. Robert Rand did not enter a plea during his appearance in federal court Monday in Reno...Rand has been indicted and charged with taking part in a criminal prescription drug distribution ring...His attorney, John Arrascada, told News 4 that Rand would plead not guilty to all charges...Eight other people have been indicted by a federal grand jury. All eight have pleaded not guilty to the charges they face individually, though only Richard Winston West II remains detained...Doctor Robert Rand will be arraigned...to enter a plea on charges of conspiracy to distribute and possess with intent to distribute controlled substances...
- Drug industry overstates impact of patent reviews on innovation (statnews.com)
Drug makers complained bitterly...after the Supreme Court left intact a controversial procedure for reviewing patent disputes, arguing that the decision threatens valuable research efforts and that patients will eventually suffer. But the truth of those claims is debatable...The ruling upheld a process Congress created...for challenging patents outside the courts. It allows the Patent and Trademark Office to issue the "broadest reasonable interpretation" of patents. The case at hand had nothing to do with pharmaceuticals, but drug makers believe it will make their patents more easily challenged, and more likely to be overturned...The companies believe the procedure, known as inter partes review, is riskier than patent disputes decided in federal courts... Without the promise of effective patent rights, investments [in new medicines] would be far more difficult — if not impossible — to undertake...
- Gilead won’t have to pay $200 million in patent case because Merck lawyer lied (statnews.com)
In an embarrassing blow to Merck, a federal court judge...decided that Gilead Sciences does not have to pay $200 million in damages that was recently awarded in a patent dispute because Merck displayed a "pervasive pattern of misconduct."...At issue was testimony from a retired Merck patent attorney, who was found to have "lied" repeatedly when recounting events that took place more than a decade ago concerning patents for hepatitis C compounds...Merck held exploratory talks with another company, Pharmasset, about a collaboration...Merck lawyer, Philippe Durette, intentionally gave false testimony during a deposition and a recent trial about his role in those talks...After spending $11 billion to acquire Pharmasset in 2011, Gilead virtually struck gold when it launched the first of the Pharmasset hepatitis C compounds, called Sovaldi...Merck sought royalties from Gilead, claiming the Pharmasset compounds closely mimicked the hepatitis C compounds it was researching a dozen years ago, when talks with Pharmasset were held...Gilead...is "pleased" by the decision that Merck’s patents are unenforceable against Gilead...Merck’s patents are invalid and unenforceable, and we feel vindicated by today’s decision...
- Genentech accused again of cheating health care providers (statnews.com)
Yet another health care provider is accusing Genentech of fudging the amount of the Herceptin medicine that the company provides in each vial, causing the facility and many other hospitals to overpay for the pricey treatment...the Comanche County Memorial Hospital filed a lawsuit alleging that Genentech...shortchanges hospitals by placing less of the breast cancer medication in vials, or alternatively, misrepresenting the amount of the drug that must be mixed in a solution. Under either scenario, the lawsuit contends providers would unnecessarily be forced to purchase additional vials...Genentech maintains that its medicine comes in vials as a freeze-dried powder, which must be mixed with a liquid. But the hospitals and health care providers contend that the resulting solution yields less than the amount claimed by the drug maker...
- French prosecutors open probe into fatal drug trial (reuters.com)
Paris prosecutors...have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January...The prosecutors' office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result of clinical risks involved...France's Health Ministry said last month that Portuguese drugmaker Bial and French laboratory Biotrial were at fault "on several counts" for the drug trial...
- More Charges Against Ex-Pharmaceutical Executive Martin Shkreli (dddmag.com)
Federal prosecutors in New York have filed additional criminal charges against a pharmaceutical executive who separately was heavily criticized for raising the price of a lifesaving malaria medication...A new indictment filed Friday in Brooklyn says Martin Shkreli and his former attorney Evan Greebel schemed to defraud potential investors of his former drug company Retrophin Inc...They say the two allocated company stock to seven employees to conceal Shkreli's ownership of it...Shkreli previously pleaded not guilty to charges he lost investors' money through bad trades and looted the pharmaceutical company to pay them back.
- Former pharma exec headed to trial on kickback allegations (statnews.com)
- Between 2009 and 2012, W. Carl Reichel allegedly orchestrated a campaign to give doctors money, free meals, and phony speaking fees in exchange for prescribing medicines sold by Warner-Chilcott, where he had been the president of the pharmaceutical division...he goes on trial in what is expected to be a closely watched case in the pharmaceutical industry. That’s because the case marks one of the relatively few instances in which federal prosecutors have sought to hold a high-ranking executive from a drug maker accountable for such activities...drug company executives have faced penalties for illegal activities. Notably, three former executives at Purdue Pharma pleaded guilty in 2007 to misleading the public about the risk of addiction posed by the OxyContin painkiller. They were also banned from any dealings with federal health care programs...such instances are relatively rare...In the Reichel case, the feds allege that he developed and oversaw an illegal strategy to boost prescriptions for several drugs, including the Actonel osteoporosis treatment and the Doryx acne medicine. Among the charges: Reichel provided sales reps with unlimited expense accounts in order to wine and dine doctors, and he suggested targeting doctors who were already frequent prescribers, according to the indictment...He faces no more than five years in prison, three years of supervised release, and a fine of $250,000.