- Oklahoma top court clears way for Purdue, J&J, Teva to face opioid trial (reuters.com)
Oklahoma’s top court...declined to delay a landmark trial set for May in a multibillion-dollar lawsuit accusing OxyContin maker Purdue Pharma LP and two other drugmakers of helping fuel an opioid abuse and overdose epidemic in the state...The Oklahoma Supreme Court’s decision was a win for the state’s attorney general, whose case is set to be the first to face trial of roughly 2,000 lawsuits nationally seeking to hold opioid manufacturers responsible for contributing to the epidemic...Oklahoma Attorney General Mike Hunter’s 2017 lawsuit accuses Purdue, Johnson & Johnson & Teva Pharmaceutical Industries Ltd of engaging in deceptive marketing that downplayed the risks of addiction associated with opioid pain drugs while overstating their benefits...READ MORE
- Canada to create national drug agency to help cut cost of medicines (reuters.com)
Canada will create a national drug agency to help cut the cost of prescription medications as part of a plan to broaden the state-funded healthcare program, the finance ministry said in its budget...Unlike other countries with universal healthcare, Canada does not cover prescription drugs, leaving most Canadians to rely on a mixture of public and private insurance plans...Prescription drug spending in Canada has jumped to C$33.7 billion ($25.3 billion) in 2018 from C$2.6 billion in 1985 and a promise to boost drug coverage is set to be a major plank for the ruling Liberals in an election this October...The new Canada Drug Agency would “take a coordinated approach to assessing effectiveness and negotiating prescription drug prices,” which could help lower the cost of medications by up to C$3 billion a year in the long term...READ MORE
- NCI Director Norman Sharpless named acting FDA chief (sciencemag.org)
Norman Sharpless
Norman Sharpless, director of the National Cancer Institute in Bethesda, Maryland, will become acting administrator of the U.S. Food and Drug Administration...after current FDA chief Scott Gottlieb steps down in early April...The highly regarded Gottlieb reportedly recommended Sharpless as his replacement. He tweeted today: “I’m delighted by the announcement from @SecAzar that @NCIDirector will serve as acting commissioner of #FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”...READ MORE
- How Scott Gottlieb changed the FDA (biopharmadive.com)
Scott Gottlieb took over as head of the Food and Drug Administration with a somewhat unconventional agenda...He quickly won over skeptics...And while the agency's core missions of drug and food safety remain unchanged, Gottlieb was able to elevate different, specific issues into the limelight...e-cigarettes, opioids and drug prices gave the agency new focus at the highest level...Gottlieb's willingness to call out drugmakers for what he memorably dubbed "shenanigans" and "Kabuki drug pricing" pushed the industry in a more public manner than past agency chiefs...Under his leadership, the FDA flagged anti-competitive concerns including drugmaker abuse of the REMS system and citizen petitions, as well as publishing a list of off-patent drugs with no generic competition...READ MORE
- This Week in Managed Care: March 22, 2019 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Amgen taps comedian Jay Leno for ‘cholesterol 911’ awareness push (fiercepharma.com)
Comedian and former late night host Jay Leno isn’t laughing about his cholesterol numbers. But he is using humor to get the message across in an awareness campaign with Amgen that focuses on the dangers of high cholesterol...The new campaign, “Cholesterol 911,” looks to sound the alarm with digital and social media creative combining Leno’s love of cars, his personal cholesterol concerns and a dash of humor. The 911 theme is an effort “to bring urgency to this message and help people avoid an emergency situation,”...READ MORE
- 5 takeaways from Scott Gottlieb’s surprising FDA departure (biopharmadive.com)
Scott Gottlieb has submitted his resignation as commissioner of the Food and Drug Administration, after nearly two years at the helm of the agency. Gottlieb plans to leave next month...The unexpected exit has created a number of uncertainties for the pharmaceutical industry. More clarity should come in the lead up to the leadership change. In the meantime, here are five key takeaways from Gottlieb's departure and time at the FDA...READ MORE
1. Who will be Gottlieb's successor?
2. Why is he leaving the FDA?
3. What work does Gottlieb leave unfinished?
4. How will the industry react to Gottlieb's departure?
5. What will Gottlieb's legacy be?
- March 22 Pharmacy Week in Review: APhA Annual Meeting & Exposition, Epilepsy Foundation Releases New PSAs (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.
- First diabetes drug transparency report reveals profits, costs associated with treating the disease (thenevadaindependent.com)Supplemental Report 2017 Essential Diabetes Drugs (dhhs.nv.gov)
Drug manufacturers earned an average of $1.58 in profit for every $1 they spent on the production and administration of diabetes drugs in 2017, according to a report released by the Nevada Department of Health and Human Services...But the diabetes drug report...found wide variations in the profitability of drugs used to treat diabetes based on data provided by manufacturers to the state. Although some drug companies reported losses, 69 percent reported of manufacturer reports indicated profits greater than the combined cost of production and administrative expenditures, including some with profits more than 20 times combined costs...The long-awaited report comes nearly two years after lawmakers passed a bill requiring manufacturers of diabetes drugs and PBMs to submit annual reports to the state detailing the costs associated with those drugs and explaining any price increases. The first report based on that information was initially slated to be released in September...READ MORE
- Cancela to introduce trio of pharmaceutical bills to rein in high drug costs (thenevadaindependent.com)
Nevada State Capitol Building, Carson city
After taking on the pharmaceutical industry two years ago with an insulin pricing transparency bill, Democratic state Sen. Yvanna Cancela plans to continue...A suite of three bills, which Cancela plans to introduce next week, will establish a prescription drug review board, create additional pharmaceutical pricing transparency requirements and mandate that savings in the drug pricing process are passed along to patients. Like the legislation last session, the bills will address the roles that both pharmaceutical manufacturers and the middlemen in the drug pricing process, called pharmacy benefit managers, play in determining drug costs...The pharmaceutical industry has challenged a host of recent state legislation, including bills in California and Maryland, attempting to rein in drug costs by arguing that they violate the Commerce Clause, which restricts the power of states to regulate interstate commerce...READ MORE