Author: Peter

Tasmania could become the first state in Australia to introduce pill testing, with the push gaining support from a maverick Liberal MP and the Dark Mofo festival, which may go it alone to offer a testing service...Festival organisers are meeting with Pill Testing Australia, which conducted the country's first pill testing trial in the ACT last year...Six people have died from suspected drug overdoses at music festivals across Australia this year, prompting renewed calls for testing to be rolled out nationwide...Australia's first pill testing trial was held at Canberra's Groovin the Moo festival last year after being approved by the ACT Government. A second trial will be held at the event this year...READ MORE

Jaime Rosenberg, welcome to This Week in Managed Care from the Managed Markets News Network

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?

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

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

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.

Two bills introduced in a Senate health committee...in the Legislature would protect health care benefits in Nevada...Senate Bill 235 would extend pre-existing condition protections created by the federal Affordable Care Act to state law...If SB235 is approved, those with chronic conditions would continue to be protected from discrimination by insurers...A second bill, SB192, introduced in the committee...would require employers to offer comprehensive health coverage that covers all of the ACA’s 10 essential health benefits, including prescription and maternity coverage, if they pay employees at the lower end of a two-tiered minimum wage system...READ MORE

Most prescription drugs contain at least one inactive ingrediant (sic) capable of causing adverse reactions, according to a new study...Researchers from Brigham and Women’s Hospital at Harvard and Massachusetts Institute of Technology found these medications to contain lactose, peanut oil, gluten or chemical dyes...The team analyzed 42,052 different oral medications and found that nearly 93 percent of them contained at least one inactive ingredient that could cause adverse reactions in certain conditions, such as peanut oil, lactose or dyes. And other medications included ingredients that people were sensitive to, including gluten and some kinds of sugar compounds...READ MORE

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

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