Author: Peter

A unit of Insys Therapeutics Inc pleaded guilty...to fraud charges as part of an $225 million deal with the U.S. Justice Department resolving claims that the drugmaker bribed doctors to prescribe an addictive opioid medication...The plea...by the Chandler, Arizona-based Insys’ operating subsidiary, came in one of the few criminal prosecutions to date of a corporation accused of helping fuel the nation’s deadly opioid epidemic...Insys is facing growing financial pressures as a result of the U.S. probe and a decline in sales of its flagship fentanyl pain product, Subsys, which it has said could prompt the company to seek bankruptcy protection...Beyond the plea by subsidiary Insys Pharma Inc, Insys has also entered into a five-year deferred prosecution agreement with the government and agreed to pay $30 million in the criminal case and $195 million to resolve civil claims...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

After reviewing tens of millions of insurance claims for the country's 49 most popular brand-name prescription drugs, a team from Scripps Research Translational Institute found that net prices rose by a median of 76 percent from January 2012 through December 2017 -- with most products going up once or twice per year...The substantial price increases were not limited to drugs that recently entered the marketplace, as one might expect, or to those lacking generic equivalents. In addition, the increases often were "highly correlated" with price bumps by competitors...READ MORE

A website launched by pharmaceutical giant Eli Lilly earlier this year leads with a daunting statement about the price of its diabetes drug Trulicity: “Drug prices can be confusing,” it says. That’s for sure, and thanks to a new mandate from the Trump administration, consumers could find themselves even more confused...Centers for Medicare and Medicaid Services said in May that it will require drugmakers to include “list prices” in television ads for all medicines covered by Medicare or Medicaid that cost $35 or more for a one-month supply or for a full course. ..The confusion for consumers revolves around “list price.”...That’s the initial price charged to federal and private insurers and pharmacy-benefits managers. It’s not the copayment or retail price that most consumers end up paying. And list prices can be vastly different from the average American’s out-of-pocket cost for prescriptions...READ MORE

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

William Husel voluntarily surrendered to authorities in Columbus and was charged in 25 deaths following a six-month investigation by the Franklin County Prosecutor's Office. The patient deaths exposed a stunning case of medical oversight and alleged medical malpractice, and called into question how repeated failures potentially involving 30 or more employees could have gone unchecked for so long...Husel faces 15 years to life in prison per count if convicted. O'Brien said that the doses ordered by the doctor in the 25 deaths "could not support any legitimate medical purpose." Although nurses and pharmacists followed Husel's orders, the doctor remains the main focus of the criminal investigation...Also named in the various civil suits are the Mount Carmel Health System and some pharmacists and nurses. What remains unclear is how Husel could circumvent apparent rules that would require him to order medications through an in-house pharmacy team and then convince a nurse to administer the drug...READ MORE

Illicit chemical knock-offs of the extremely potent opioid fentanyl would be put permanently in the same legal class as heroin to boost prosecutions of traffickers and makers of the drugs, under a proposal to be unveiled...by the U.S. Drug Enforcement Administration...The new classification is meant to help fight a proliferation of chemical look-alikes of fentanyl, known as analogues...DEA Acting Chief Operations Officer Greg Cherundolo is set to go before a Senate committee...to propose that Congress make the measure permanent so that cases against various analogues will not be undercut when the temporary ban lapses...READ MORE

A federal judge...tossed the convictions of a co-owner and former employee of a Massachusetts compounding pharmacy accused of conspiring to help it evade regulatory oversight before its drugs caused a deadly 2012 fungal meningitis outbreak...U.S. District Judge Richard Stearns in Boston ruled that New England Compounding Center co-owner Gregory Conigliaro and former employee Sharon Carter did not have fair warning their actions could subject them to prosecution...Jurors convicted Conigliaro and Carter of conspiring to defraud the U.S. Food and Drug Administration by misleading it into thinking NECC was operating like a conventional pharmacy and not like a drug manufacturer...State-regulated compounding pharmacies produce customized drugs pursuant to patient-specific prescriptions to address individual needs. But prosecutors said NECC was actually a drug manufacturer making medications in bulk...READ MORE

USP released new and revised standards to help ensure the quality of compounded medicines. The updates pertain to the USP General Chapters on compounding nonsterile medicines (USP <795> Pharmaceutical Compounding—Nonsterile Preparations), compounding sterile medicines (USP <797> Pharmaceutical Compounding— Sterile Preparations) and new standards for compounding radiopharmaceutical drugs (USP <825> Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging)...READ MORE

California, Hawaii, Maine and the District of Columbia filed lawsuits...against the maker of OxyContin (Purdue Pharma) and the company’s former president (Sackler), alleging the firm falsely promoted the drug by downplaying the risk of addiction while it emerged as one of the most widely abused opioids in the U.S...allegations...said the company falsely introduced OxyContin in the 1990s as a safe and effective treatment for chronic pain...However, the California’s lawsuit alleges that Purdue and Sackler knew in 1997 that drugs containing oxycodone...were widely abused. Still, company representatives marketed it as not being addictive and downplayed the potential for abuse, the suit states...READ MORE