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In a setback to the pharmaceutical industry, the US Supreme Court declined on Tuesday to hear an appeal sought by Johnson & Johnson of a $63 million verdict that found the company failed to properly warn consumers about the risks of its Children’s Motrin painkiller...At issue was whether J&J should have upgraded its product labeling to reflect the risk that a patient may develop toxic epidermal necrolysis, which can lead to a rare disease called Stevens-Johnson syndrome...J&J sought to convince the Supreme Court that federal law preempted the state court verdict. In response to a citizen’s petition seeking upgraded labeling, the Food and Drug Administration had agreed that an increased warning about skin reactions — such as rashes and blisters — was warranted. But the agency did not agree to add the names of the skin diseases…the company maintained it would have violated federal law if the Motrin labeling was updated with the sort of specific language the family believed should have been used, according to its filing with the Supreme Court...J&J complained it was in an untenable bind…J&J, which now faces a $140 million payout when including interest...is “disappointed the Supreme Court declined to hear this case because we believe it raises important and unsettled preemption issues.”

U.S. patent officials...denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine...In June, Amgen...asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion...In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."...Amgen said it still plans to challenge the legality of the patents.

Community pharmacy negotiators are refusing to negotiate with the government over its planned 6% cut in community pharmacy funding in England until it has seen details of the government’s long-term plans and the evidence behind them...The move comes as the Pharmaceutical Services Negotiating Committee voiced its fears that the government is deliberately keeping it in the dark about deeper cuts to come...We cannot agree to commence negotiations before we have had an opportunity to understand fully your plans and the analysis underpinning them…We believe we are entitled to this material but it has not been forthcoming. The government appears to have a settled intention to proceed on a course of action that will run counter to its stated ambition to develop a clinically focused pharmacy service, and be damaging to patient care...the 6% cut will force pharmacies to cut staff and damage patient confidence in the profession; the PSNC is also suspicious of government plans to create more online pharmacy services.

Nevada officials on Wednesday assured advocates in Clark County that any process to privatize Medicaid services for the elderly, blind and disabled will move slowly and will be transparent...Advocates with Nevadans for the Common Good, a coalition of Las Vegas Valley institutions advocating for several issues including protection for vulnerable senior citizens...met privately with state officials. Attendees at the closed-door meeting included Richard Whitley, director of the state's Health and Human Services Department...Barbara Paulsen, leader with Nevadans for the Common Good, said the meeting was positive and that advocates were pleased with what they learned. She said the coalition's push for transparency and the Las Vegas Review-Journal's reporting to get the information on the potential switch out to the public may have had an "impact on the process."..."Our concern was that the decision was already made and it was just all going to go very quickly without getting any input (from the public)," she said Wednesday. "That doesn't seem to be the case."...After gathering information, state officials will develop a report that will be sent to the governor and the Legislature, she said. The governor would ultimately have to make a recommendation, which the state's Interim Finance Committee would have to approve, according to the legislation.

NOTICE OF TOWN HALL AND LISTENING SESSION ON MEDICAID MANAGED CARE EXPANSION OPTIONS

• 1/20/2016 Clark County Library - 1401 East Flamingo Road - Las Vegas
• 2/2/2016   Sahara West Library - 9600 West Sahara Avenue - Las Vegas
• 2/2/2016 Summerlin Library - 1771 Inner Circle - Las Vegas
• 2/17/2016 William Bee Ririe Hospital - 1500 Avenue H - Ely
• 2/19/2016 Humboldt General Hospital - 118 E. Haskell Street - Winnemucca

The patient left brain-dead in last week's botched drug trial has died, French authorities said, spurring more questions about how a routine Phase I study went awry and sent 6 volunteers to the hospital…The patient, dosed with an investigational drug from Portugal's Bial, died Sunday, about a week after the company's CRO halted the study in response to serious side effects. The 5 other hospitalized patients remain in stable condition…In the ensuing fallout, regulators and scientists are struggling to piece together what went wrong in the trial… investigators had yet to determine whether the problems were related to the drug's mechanism of action or the result of contaminated doses…"Together with all the relevant authorities, Bial is strongly committed to ensuring, first of all, the well-being of all participants in this trial and to determine thoroughly and exhaustively the causes which are at the origin of this situation," Bial said in a statement.

A longtime Elko obstetrician whose medical privileges have been revoked has filed a lawsuit against Northeastern Nevada Regional Hospital...Dr. George A. Winch Jr. and the Elko Women’s Health Center filed the complaint...The complaint alleges that “NNRH began a campaign to suspend and revoke Dr. Winch’s privileges from NNRH based upon pre-textual, wrongful and false grounds.”...Furthermore, it says the “defendants’ bad faith breaches of the implied covenant were done maliciously, fraudulently, and oppressively, with the wrongful intention of injuring plaintiffs, and acted with an improper and evil motive amounting to malice, and in conscious disregard of the plaintiff’s rights.”

Ron Lanton – with True North Political Solutions brings another Health Policy Check-Up Segment with State Rep. Heidi Brooks with the state of Maine House of Representatives. They discuss MAC Drug Pricing Transparency and other pressing issues to our pharmacy industry.    (podcast 23:19 minutes)

Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.

Food and Drug Administration on Friday issued draft guidelines to medical device makers on how to protect patients from cybersecurity vulnerabilities in the devices...Cybersecurity threats to medical devices are a growing concern...The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices...The draft guidance, which is not legally binding, recommends companies take a number of actions, including monitoring and assessing risk, adopting a coordinated vulnerability disclosure policy, and taking measures to address cybersecurity risk early.

What’s in a name?...Plenty, especially if you happen to run a company called Merck. In fact, there are two drug makers with that moniker. One is based in the United States and the other is headquartered in Germany, but is formally known as Merck KGgA (Merck Kommanditgesellschaft auf Aktien). And not surprisingly, they are warring over use of the name — again...To be specific, the company in Germany has the rights to use the Merck name everywhere in the world, except in the US and Canada. However, the English High Court has just ruled that the other Merck — the drug maker that is based in the US — breached a 46-year-old agreement and infringed on a trademark by using the name ‘Merck’ alone in the United Kingdom...In the lawsuit filed today, the US Merck argues that its German rival is deliberately pursuing a confusing corporate branding campaign as part of a revamped US business to bolster its presence in oncology...why do both drug makers have the same name?...The original Merck was established as a drug manufacturer in Germany in the 1800’s, but a Merck descendant later immigrated to the US and created a unit known as Merck & Co., which is based in New Jersey. But the company was confiscated by the US government during World War I and later established as a separate drug maker...Perhaps all of this would make more sense if the companies were renamed ‘Murk.’