- AmerisourceBergen says civil penalty to resolve DOJ probe now at $625M (fiercepharma.com)
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.”
- Drug Companies Are Warming Up to the Idea of an Amazon Pharmacy (bloomberg.com)
The market is buzzing with speculation that Amazon.com Inc. will enter the pharmacy business. Some drugmakers are just fine with changes the tech retail giant might bring to the complex market...Drug companies say getting medicine into patients’ hands is too complicated and costly. Some have pointed to the multiple layers of middlemen -- including insurers, pharmacy benefit managers, distributors and pharmacies -- as one reason for distorted prices and high costs in the U.S...Amazon’s entry could bring more efficiency, Takeda Pharmaceutical Co. Chief Executive Officer Christophe Weber said during an interview in London. That could impact business in the U.S. or in other markets...“I am all in favor of a more effective distribution system,” Weber said, adding that in some countries the markup can be higher than the manufacturer’s own price. “For us it doesn’t matter so much where the point of sale is, as long as we reach the patient.”
- Fentanyl Billionaire John Kapoor To Plead Not Guilty In Opioid Kickback Case (forbes.com)
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.
- Why Major Hospitals Are Losing Money By The Millions (forbes.com)
According to the Harvard Business Review, several big-name hospitals reported significant declines and, in some cases, net losses to their FY 2016 operating margins...How did some of the biggest brands in care delivery lose this much money? The problem isn’t declining revenue...Part Of The Problem Is Rooted In The Past...From the late 19th century to the early 20th, hospitals were places the sick went to die. For practically everyone else, healthcare was delivered by house call. With the introduction of general anesthesia and the discovery of powerful antibiotics, medical care began moving from people’s homes to inpatient facilities. And by the 1950s, some 6,000 hospitals had sprouted throughout the country...By the time Medicare rolled out in 1965, healthcare consumed just 5% of the Gross Domestic Product. Today, that number is 18%...Hospitals have contributed to the cost hike in recent decades by: (1) purchasing redundant, expensive medical equipment and generating excess demand, (2) hiring highly paid specialists to perform ever-more complex procedures with diminishing value, rather than right-sizing their work forces, and (3) tolerating massive inefficiencies in care delivery...Most hospital leaders acknowledge the need to course correct, but very few have been able to deliver care that’s significantly more efficient or cost-effective than before. Instead, hospitals in most communities have focused on reducing and eliminating competition. As a result, a recent study found that 90% of large U.S. cities were “highly concentrated for hospitals,” allowing those that remain to increase their market power and prices...
- Pfizer in fight with states over their intent to use its drugs for executions (fiercepharma.com)
Pfizer is in a tug of war with several states that intend to use some of its drugs to carry out executions...The drugmaker sent letters last month to both Nevada and Nebraska asking for the return of drugs, which include the sedative diazepam and the opioid painkiller fentanyl, if the states intended to use them for executions...The company said it would reimburse the states...Nevada has already indicated it does not intend to return the drugs, which the state obtained from wholesaler Cardinal Health...“We have communicated to the Departments of Correction in the 31 states permitting use of lethal injection for capital punishment that Pfizer strongly objects to the use of its products as lethal injections for capital punishment. We have asked all such states to return any Hospira or Pfizer manufactured Restricted Product in their possession and provided them with procedures to follow in return for a full refund.”...Nevada, in its first execution in 11 years, wants to use an execution cocktail containing the never-before-tried combination of diazepam, fentanyl and the muscle paralytic cisatracurium...Last week's scheduled execution was delayed while the state supreme court reviews the matter after a state judge rejected the prison system's intent to use cisatracurium in the lethal cocktail. The state attorney general is appealing that decision.
- FDA Begins Adding Suffixes to Newly Approved Biologics’ Names (raps.org)
The US Food and Drug Administration this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015...The first additions of the meaningless suffixes came for...approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, and...approval of Ultragenyx Pharmaceutical's Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with a rare inherited condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome...The newly added suffixes were not preceded by an announcement from FDA, though the shift was not entirely unexpected...Back in January, FDA finalized guidance on how biosimilars and their biologic reference products' names should include this four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name...But until this week, only new biosimilars had the suffixes attached to their names. The agency did not respond to a request for comment on why new biologics' nonproprietary names included the suffixes this week.
- Lab-Grown Mini Organs Could Speed Up Drug Discovery (forbes.com)
The thought of lab-grown organs conjures up Frankenstein-like imagery. The reality however, is somewhat less visually dramatic, with the term ‘organoids’ used to describe tiny 3D structures of human tissue, a millimeter or so in diameter...these tiny lumps of cells are creating a lot of excitement in the world of medical research...Cells in dishes and animal models have been used for preclinical testing of drugs for decades. Success in these experiments is a key hurdle for any new medicine to overcome before being given the green light for all-important human clinical trials...Organoids are most commonly made either from a small sample of tissue needled out of a person or from stem cells cultured in a cocktail of nutrients intent on pushing them towards becoming a particular tissue type. So far, organoids have been made resembling several tissues including lung, liver, brain, kidney and intestine...as a relatively new innovation they are being used to investigate dozens of conditions from infectious diseases to cancer.... A study published last year in Science Translational Medicine by scientists at the University Medical Centre, Utrecht generated organoids formed from the rectal tissue of 71 people with cystic fibrosis and exposed them to experimental drugs. By observing changes in the organoids, the scientists accurately predicted which patients would respond to the therapies in just one week at a cost of around $1200 per patient. The results were so convincing that a positive organoid test is now considered sufficient evidence for insurance companies to fund the new therapies in the Netherlands...
- CVS may have a secret weapon against Amazon’s move into healthcare (CVS, AMZN) (markets.businessinsider.com)
CVS is reportedly in talks to buy Aetna in a deal that could help protect its business from the entry of the tech giant in to the healthcare space...CVS should focus on its vertical integration strategy, according to Morgan Stanley, and steer clear of gong head to head with Amazon in next day or same day delivery...Don't go head-to-head with Amazon...Goldwasser said that CVS' strength is its vertical integration. CVS has made a number of acquisitions over the past decade, such as Caremark RX, a pharmacy benefits manager, Omnicare, a leading pharmacy services provider and Target's pharmacy and retail clinic businesses. That push puts the company on a better footing to engage consumers, improve access to care, and deliver cost savings, he said.Goldwasser said however that any plans to go head-to-head with Amazon in next-day or same-day delivery service of prescriptions may impact the company's front-store sales. CVS already offers this service and plans to expand it to all of its locations in 2018.
- Europe’s drug industry waits for white smoke in Brussels (reuters.com)
It may be a cross between the Eurovision Song Contest, a papal conclave and a social club raffle but a ballot among EU ministers...could hurt Europe’s pharmaceutical industry and the health of millions...It will fix the new home of the European Medicines Agency, which must leave London by 2019 when Britain leaves the European Union; most of its 900 staff may refuse to move to many of the 19 cities in the running, the EMA warns. Replacing them would delay drug approvals and patient safety checks...Yet the result, diplomats agree, is utterly unpredictable; months of horse-trading on issues unrelated to healthcare will end up in hours of haggling between secret ballots in Brussels...It could even come down to drawing lots...Senior officials liken the process to Europe’s annual TV music schlock-fest, when the winner of the Eurovision Song Contest is often determined by viewers phoning in votes for acts from like-minded neighbouring states and historic allies...British bookmaker Ladbrokes has Milan the 2-1 favorite to secure the EMA...seasoned diplomats hesitate to quote odds: “The most likely result is one that will be perverse,” said one, recalling previous upsets behind closed doors...Another referred to closeted cardinals electing popes at the Vatican: “In the end,” he said, “We will get the white smoke.”
- FDA Expands Generic Drug Priority Reviews (raps.org)
Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue...The progress comes as Food and Drug Administration Commissioner Scott Gottlieb...indicated that the agency will expand which abbreviated new drug applications will see priority reviews..."Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug," Gottlieb said in a statement. "Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine."...The shift could accelerate generic competitors to market more quickly and help bring down costs, and comes a day after the Federal Trade Commission held a workshop on drug competition.