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Kentucky has sued Walgreens for its role in the state's opioid epidemic...Attorney General Andy Beshear filed the suit against Walgreens for its dual role as a distributor and a pharmacy, saying it allegedly failed to monitor its own operations and shipped and dispensed large amounts of opioids...The lawsuit alleges "unfair, misleading and deceptive business practices by Walgreens for excessively distributing and dispensing opioids in Kentucky and for failing to legally report to state and federal authorities the suspiciously large orders it received for prescription opioids."...This is the sixth opioid-related suit Beshear has filed. He's sued three drug distributors, AmerisourceBergen, which Walgreens Boots Alliance owns a roughly 26 percent stake in, McKesson and Cardinal Health. He's also sued pharmaceutical manufacturers, including Johnson & Johnson.

Ohio Attorney General Mike DeWine reports the state has begun settlement talks with opioid-makers it has sued alleging illegal marketing, and will meet with a federal judge urging settlement of hundreds of similar suits, in early steps toward resolution of the litigation. DeWine's staff held separate settlement discussions with Johnson & Johnson and Teva Pharmaceutical Industries..."We outlined with them where we feel Ohio needs help—in prevention, education and treatment, as well as the huge problem we’re having with our foster-care system because so many of the parents are addicted," says DeWine. Teva said in a statement, "We appreciate the opportunity to meet with representatives of the Ohio AG’s office to discuss this important public health issue." Johnson & Johnson said: "While we consider the specifics of our discussions with state attorneys general to be confidential, we continue to maintain that allegations made in lawsuits against our company are baseless and unsubstantiated. ... At the same time we recognize that opioid abuse and addiction are serious public health issues that must be addressed...we look forward to being a part of the ongoing dialogue."

Shortages of drugs and saline produced in Puerto Rico are beginning to materialize after Hurricanes Irma and Maria wreaked havoc on production on the island, which produces about 10% of the U.S. drug supply including products like Lipitor and blood thinner Xarelto...Saline solution was already suffering supply restraints before the storms knocked out power to plants across island, affecting saline production at a facility operated by Baxter International...The company, which has said it lost days of production as a result of the storms, has put customers on allocation of sodium chloride and will try to make up for some of that supply by importing saline and glucose from plants in Australia and Ireland...The FDA has said that there are about 40 drugs manufactured in Puerto Rico, 13 of them exclusively, and that shortages of some of those will be materializing within days. The storms knocked out power, and while manufacturers have backup generators, they could be without commercial power for months. Most of the facilities that have resumed production, maintain only partial operations…

A California jury...ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian cancer after using the company's talc-based products like Johnson's Baby Powder for feminine hygiene...The Los Angeles Superior Court jury's verdict in favor of California resident Eva Echeverria was the largest yet in lawsuits alleging J&J failed to adequately warn consumers about the cancer risks of its talc-based products...The verdict included $70 million in compensatory damages and $347 million in punitive damages. It was a major setback for J&J, which faces 4,800 similar claims nationally and has been hit with over $300 million in verdicts by juries in Missouri...The 63-year-old claimed she developed terminal ovarian cancer after decades of using J&J's products. Her lawyers argued J&J encouraged women to use its products despite knowing of studies linking ovarian cancer to genital talc use...

The Justice Department said...it will support local officials in hundreds of lawsuits against manufacturers and distributors of powerful opioid painkillers that are fueling the nation's drug abuse crisis...The move is part of a broader effort to more aggressively target prescription drugmakers for their role in the epidemic, Attorney General Jeff Sessions said. The Justice Department will file a statement of interest in the multidistrict lawsuit, arguing the federal government has borne substantial costs as a result of the crisis that claimed more than 64,000 lives in 2016...the Justice Department...which has also sought to crack down on black market drug peddlers and doctors who negligently prescribe...Targets of the lawsuits include drugmakers such as Allergan, Johnson & Johnson, and Purdue Pharma, and the three large drug distribution companies, Amerisource Bergen, Cardinal Health and McKesson. Drug distributors and manufacturers named in these and other lawsuits have said they don't believe litigation is the answer but have pledged to help solve the crisis.

With a new administrator at the helm, the U.S. Food and Drug Administration took steps toward regulating decision support, software-as-a-medical-device, mobile tech in clinical trials and more...the FDA had a full plate in 2017 as it sought to revise its regulatory processes for the shifting healthcare landscape...the new guard already had announced and implemented a firm-focused pre-certification program, released new guidances addressing provisions of 2016's 21st Century Cures Act, and outlined a handful of other ongoing initiatives that are sure to impact the digital health industry. Here's a rundown of the agency's actions and announcements during 2017.

• New leadership, new approaches
  ...a plan that included clear language on which devices the agency would look to regulate, an app regulation strategy involving postmarket data collection, and other idea designed to streamline the approval process...FDA opened up applications for a pilot of a firm-focused digital health pre-certification program...nine companies selected to participate: Apple, Samsung, Verily, Pear Therapeutics, Tidepool, Phosphorus, Fitbit, Roche, and Johnson & Johnson...draft of the long-awaited and somewhat controversial guidance on clinical decision support, which laid out the forms of clinical decision support that would or wouldn't be regulated based on the degree of human involvement (as opposed to risk)...draft guidance describing the FDA's new Breakthrough Devices Program...would supersede the Expedited Access Pathway and aims to push novel technologies presenting a significant improvement over status quo through the clearance process more quickly.

• FDA shifts toward digital, patient feedback
  ...the Clinical Trials Transformation Initiative – a public-private partnership of pharma companies, academics, and regulators including the FDA – released new endpoint recommendations for the use of mobile technologies in clinical trials... The guidelines, meant to be the first in a series of such documents, included suggestions for study designers when selecting novel endpoints, practical approaches when developing these endpoints...

Big pharma stands to make hundreds of billions of dollars from a handful of medical conditions.

• No. 7: Viral hepatitis - $45 billion and $55 billion will be spent globally on drugs that treat viral hepatitis by 2022...around 257 million have chronic hepatitis B virus infection and 71 million people have chronic hepatitis C virus infection.
• No. 6: Respiratory diseases - treating respiratory diseases are expected to generate between $53 billion and $56 billion in sales by 2020. The most common respiratory diseases include asthma, allergies, and chronic obstructive pulmonary disease.
• No. 5: Autoimmune diseases - Autoimmune disease medications could make big pharma companies between $55 billion and $65 billion by 2020
• No. 4: Cardiovascular diseases - cardiovascular disease drugs will rack up sales between $73 billion and $76 billion by 2020...Cardiovascular drugs include treatments for hypertension, heart disease, and cholesterol.
• No. 3: Pain - Pain medications are projected to be the third-biggest moneymaker by 2020, with sales of $82 billion to $85 billion...drugs includes treatments for musculoskeletal pain, arthritis, anesthesia, analgesics (both narcotic and non-narcotic), and migraine.
• No. 2: Diabetes - diabetes drugs are expected to be near the top in spending, with projected global sales between $107 billion and $113 billion by 2020
• No. 1: Cancer - The top medical condition that will likely line big pharma's pockets by 2020 is cancer…sales of cancer drugs will be between $100 billion and $120 billion

A U.S. administrative court...invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions...The Patent Trial and Appeal Board said a Johnson & Johnson patent describing a method of administering Zytiga should not have been granted because the process it described was obvious...The ruling was a victory for U.S. generic drug company Argentum Pharmaceuticals LLC, which had asked the board to invalidate the patent in hopes of bringing its own version to market...The patent is due to expire in 2027. Argentum and other generic drug makers have been blocked from launching their own versions of the cancer drug until its expiration date...Zytiga generated nearly $2.3 billion in sales for Johnson & Johnson in 2016.

Pharma companies have faced a gamut of allegations over the years, but a new lawsuit ups the ante by alleging several drugmakers paid bribes in Iraq that helped fuel terrorism...the lawsuit alleged that top pharma companies Pfizer, Roche, Johnson & Johnson and AstraZeneca paid bribes to secure healthcare contracts in Iraq. Those payments ultimately supported terrorism that hurt or killed U.S. service members...More than 100 veterans or their family members are suing the drugmakers under the Anti-Terrorism Act...The lawsuit said the "terrorist-finance mechanism was straightforward: the terrorists openly controlled the Iraqi ministry in charge of importing medical goods, and defendants—all of which are large Western medical-supply companies—obtained lucrative contracts from that ministry by making corrupt payments to the terrorists who ran it."

Quest Analysis of 3.4 million tests shows evidence of dangerous drug combinations...A majority of test results from patients taking prescription medications show signs of drug misuse—including potentially dangerous drug combinations...The Quest Diagnostics Health Trends study is based on analysis of the company's de-identified laboratory data, believed to be one of the largest nationally representative datasets of objective laboratory information of patients prescribed opioids and other commonly abused medications. Physicians order laboratory services to aid their ability to monitor patients for signs of prescription or illicit drug misuse or abuse...(The report, "Prescription Drug Misuse in America: Diagnostic Insights in the Growing Drug Epidemic")

• evidence of misuse has declined in recent years, 52% of test results showed evidence of potential misuse in 2016, suggesting a majority of patients took their prescribed drugs in ways that were inconsistent with their physician's instruction...
• disturbing patterns of concurrent drug use. Among more than 33,000 specimens tested for opioids, benzodiazepines, and alcohol in 2016, more than 20% were positive for both opioids and benzodiazepines, more than 10% were positive for both opioids and alcohol, and 3% were positive for all three...
• 19% of specimens positive for heroin in 2016 were also positive for nonprescribed fentanyl...
• drug misuse rates were high among most age groups and both genders. However, adolescents (10 to 17 years of age) showed a striking improvement, with the rate dropping from 70% to 29% between 2011 and 2016...
• Misuse rates were higher for men and women of reproductive age (58%) than in the general study population (52%)