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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

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

The US Food and Drug Administration has sent a warning letter to Canadian drug distributor CanaRx following an investigation, which found the company has been facilitating the distribution of unapproved and misbranded drugs to US consumers...The letter called on CanaRx to...cease distributing these products in the US and stated failure to do so could result in further regulatory action...CanaRx’s distribution scheme involves foreign physicians re-writing the prescriptions of employees of public and private organisations, which have signed up to this programme, and then supplying the patient with unapproved generic versions of FDA-approved drugs...The issue is that employees are likely to assume they are getting safe, approved medicines through their employer’s insurance plan, when in fact they may not be...READ 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

The U.S. Bureau of Prisons said...it was investigating former drug company executive Martin Shkreli's conduct in prison after the Wall Street Journal reported he was still helping run his old company using a contraband cellphone..."When there are allegations of misconduct, they are thoroughly investigated and appropriate action is taken if such allegations are proven true," the Bureau of Prisons said in a statement. "This allegation is currently under investigation."...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.

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

The Dutch hospital (Erasmus Medical Center in Rotterdam) has been offering it (lutetium octreotate) to patients for more than a decade at 16,000 euros ($18,000) for one course of treatments. Drug firm Novartis, which in 2018 acquired rights to sell it in Europe, is asking more than five times that for its proprietary version, Lutathera...Thomasa (Emar Thomasa) is part of a protest against high drug prices launched by an unlikely group of rebels: Dutch pharmacies...Amsterdam’s University Medical Center (UMC) and the Transvaal Pharmacy in The Hague - have vowed to bypass drug company products and make treatments for a handful of rare diseases themselves, exercising their right to “compound” medicines...Drug companies have raised concerns about the safety of compounded medicines that have not been approved by European regulators. But the specialized compounding pharmacies, which have on-site laboratories, have been backed by the Dutch government as part of efforts to tame rapidly rising medicine costs...READ MORE

Eli Lilly CEO David Ricks' absence from last week’s Senate Finance Committee hearing on drug prices didn’t go unnoticed. But as lawmakers from both sides of the aisle joined forces to rail against rising insulin prices, Lilly was preparing a real-world rebuttal...The company said...it will roll out a cheaper version of its Humalog insulin at half the price of its popular brand. The new version, to be called Insulin Lispro, will bear a list price of $137.35 per vial and $265.20 for a five-pack of pens...The move comes as Lilly—along with the other two top diabetes drugmakers, Sanofi and Novo Nordisk—draws increased political and legal scrutiny over insulin prices. The three companies face questioning about their price hikes on Capitol Hill later this month...READ MORE