- Exclusive: Facing crackdown in Canada, drugmakers offered billions in price cuts (reuters.com)
Canadian pharmaceutical industry lobby groups, in an effort to head off a planned crackdown on prescription drug prices, offered to give up C$8.6 billion ($6.6 billion) in revenue over 10 years, freeze prices or reduce the cost of treating rare diseases...Those industry offers did not impress federal officials, coming last year as Canada prepared to expand the powers of a little-known federal watchdog called the Patented Medicine Prices Review Board to reduce the cost of prescription drugs...The government proposals would change the countries Canada compares its prices to, dropping the United States where they are highest, and set a formula to assess cost-effectiveness of medicines...the new rules were scheduled to come into effect last month but have been delayed as the government reviews feedback, which has some wondering if they will ever be implemented...Unlike other countries with universal healthcare, Canada’s government-funded healthcare system does not cover prescription drugs. Most Canadians rely on an expensive patchwork of public and private insurance plans for that. Among industrialized nations, only the United States and Switzerland spend more on prescriptions per capita...
- U.S. lawmakers request info from insulin makers on rising prices (reuters.com)
Two powerful U.S. lawmakers sent letters to the three leading insulin manufacturers...requesting information on why its cost has skyrocketed in recent years and how much the companies profit from the life-sustaining diabetes treatment...Democratic Representatives Frank Pallone and Diana DeGette, the chairman and a top-ranking member of the House Energy and Commerce Committee, respectively, wrote to the heads of Eli Lilly and Co, Novo Nordisk and Sanofi, the long-time leading manufacturers of insulin. The drugmakers have all raised the price of insulin at similar rates over the last several years...“Despite the fact that it has been available for decades, prices for insulin have skyrocketed in recent years, putting it out of reach for many patients,” the lawmakers wrote...
- Opioid Lawsuits Are Headed to Trial. Here’s Why the Stakes Are Getting Uglier. (nytimes.com)
The judge presiding over all the federal cases had hoped to settle them by now. But the behemoth litigation is only becoming more bloated, contentious and difficult to resolve...Judge Dan Aaron Polster will preside over three consolidated lawsuits as a bellwether, or test case, in one of the most complicated legal battles in U.S. history...
Uncontested:The devastation from prescription opioids has been deadly and inordinately expensive
Contested: Who should foot the bill?
...litigation has ballooned to 1,548 federal court cases, brought on behalf of cities and counties, 77 tribes, hospitals, union benefit funds, infants with neonatal abstinence syndrome and others — in total, millions of people. With a potential payday amounting to tens of billions of dollars...
- Stunning evidence from D.E.A. records
- Going to trial is a win for plaintiffs
- The companies demand personal medical records
- Meanwhile, the plaintiffs pursue their own paper chase
- Drugstores could be held responsible for black-market fentanyl
- Why drug companies could have an upper hand
- But don't count out the plaintiffs
- But wait! There’s more! - EMA moves its headquarters from London (pharmaceutical-technology.com)EMA lays cornerstones for new Amsterdam headquarters (fiercebiotech.com)
The European Medicines Agency has begun its relocation from its headquarters in London to the organisation’s new location in Amsterdam, the Netherlands...In early January, Dutch authorities handed over a temporary building for EMA staff...the staff relocation into will be finalised on 30 March 2019...It is hoped that the move to a temporary location in time for the UK’s planned departure from the EU in March 2019 will allow the agency to remain operational during the relocation...The relocation is because the EMA must have its HQ in a European member state, meaning after the UK voted to leave the EU in 2016, the EMA had to choose a new location...
- FDA moving to ‘risk-based’ inspections even as valsartan scare adds new wrinkle to oversight (fiercepharma.com)
FDA inspections of generic drug plants are on the rise and should continue to increase through 2019...But the game has changed...with the number of pre-approval inspections growing more than surveillance inspections, in part to approve more generics in an effort to lower drug prices. This move to “risk-based” inspections...is expected to be more effective in a growing global manufacturing industry the FDA must oversee with limited resources...
- AG will recuse on selecting outside legal help for opioid lawsuit (thenevadaindependent.com)
Attorney General Aaron Ford is seeking an outside firm to represent the state in a major lawsuit against some of the nation’s largest opioid manufacturers...members of the legislative Interim Finance Committee granted the attorney general’s office permission...to open up bidding for an outside law firm to represent the state in litigation against opioid manufacturers. Ford...who...worked for a private law firm that is representing numerous Nevada municipalities in class action lawsuits, also said...that he will recuse himself from selection of outside counsel...State Consumer Advocate Ernest Figueroa, who presented the request to lawmakers, gave few details on the proposed litigation beyond stating that approval from the interim body was a required step under state law. He cited a declaration of findings signed by Ford and Gov. Steve Sisolak on Jan. 23 saying the state likely required additional legal resources to pursue litigation against companies that engaged in “unlawful and deceptive practices marketing of prescription opioids.”
- Drug Prices Are NOT Skyrocketing—They’re Barely Growing at All (drugchannels.net)
The IQVIA Institute for Human Data Science today released a new report that reveals important realities about U.S. drug pricing trends...Too many politicians and journalists remain committed to the false narrative of “skyrocketing” and “soaring” drug prices...By contrast, IQVIA data reveal that list prices for brand-name drugs grew by less than 6% in 2018. What’s more, net prices (after rebates and discounts) increased by only 1.5%. The 2018 figures mark the fourth consecutive year that net drug prices have grown by low-single-digit amounts.
- Growing UNLV Medical School focused on attracting students who will stay in Las Vegas, ease doctor shortage (thenevadaindependent.com)
Putting together a student body that looks like Las Vegas is the outgrowth of a laser focus on recruiting students committed to the area and willing to help fill big gaps in the state’s health care-workforce. Nevada is chronically short on doctors...Nevada ranks 47th in the nation for the number of active doctors per 100,000 patients, and 48th in the country for its ratio of doctors to residents. In Southern Nevada, that averages out to just over 180 full-time physicians per 100,000 residents, compared to the national average of 303...The school of medicine (UNLV School of Medicine) is projected to have an economic impact of more than a billion dollars a year and create 8,000 jobs by the time it’s fully functional in 2030. But for now, it’s still growing up — the school is asking legislators this session for an additional $14.3 million to add two new cohorts of students, more residencies and additional faculty...One of the main requirements to enter the UNLV Medical School is that the students are originally from Nevada or have strong ties to the state...Although the UNLV School of Medicine doesn’t recruit students outside Nevada...“The reason is we feel like [it’s] more likely they’ll stay to practice here after graduation. People who apply that are not from Nevada we don’t even consider,” Joncich said. “This is what we need in Las Vegas. We need doctors to stay in Las Vegas and treat Las Vegans.”
- February 1 Pharmacy Week in Review: Syphilis Increasing Among Pregnant Women, Pharmacies Offering Measles Vaccine in Outbreak Areas (pharmacytimes.com)
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.
- Insys executive gave doctor lap dance while promoting drug, witness says (reuters.com)
An ex-stripper who became a regional sales director at Insys Therapeutics Inc gave a doctor a lap dance at a Chicago club as the drugmaker pushed the doctor to prescribe its addictive fentanyl spray, a former Insys employee testified...The testimony in federal court...came in the first criminal trial of painkiller manufacturer executives over conduct that authorities say contributed to a U.S. opioid abuse epidemic... Former Insys sales representative Holly Brown told jurors the incident with her boss, Sunrise Lee, took place after Insys began rewarding the doctor for prescribing its opioid product by paying him to speak at educational events about the drug...That Illinois doctor, Paul Madison, is one of several whom prosecutors say Lee and four other former Insys executives and managers including wealthy founder and ex-chairman John Kapoor conspired to bribe to boost sales of the spray, Subsys










