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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

China...is the main source of the fentanyl coming into the United States...There are several reasons China is not helping…

First...China doesn’t do a good job of regulating its chemical and pharmaceutical industries. Producers have close relations with local Communist Party officials whose main focus is on keeping the economy humming, and not on the health and well-being of Americans thousands of miles away.

Second...no serious push from the top of the Communist Party to break this logjam. Fentanyl is hard to stop because most countries, including China and the United States, place specific chemicals on a control list. All you have to do to keep a fentanyl-like drug off the list is to tweak a few molecules...

Behind these bureaucratic snafus, however, lies something deeper...inside China’s system there’s no shortage of historical schadenfreude about the fact that the United States is dealing with a drug epidemic from China, almost two centuries after China dealt with an opioid crisis from the West...READ MORE

Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

Pfizer Inc said...it received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at its Meridian Medical Technologies site...Meridian, a unit of Pfizer that manufactures EpiPen injectors...has been hit by a series of manufacturing problems in recent years...In 2017, Meridian had received a warning letter from the Food and Drug Administration. The FDA said Meridian had failed to thoroughly investigate product failures, including EpiPen products that were associated with patient deaths and severe illnesses. It said the company failed to take corrective actions until FDA’s inspection...

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

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

Purdue Pharma may file for bankruptcy to get out from under thousands of lawsuits blaming the opioid maker and its aggressive marketing for the addiction crisis...The drugmaker is battling a weight of litigation, including state claims that target its executives and founding family, claiming it misled doctors and patients and marketed its painkillers too aggressively, helping to create a nationwide opioid crisis. Now, the company is exploring bankruptcy as a way to cope with the amassing litigation...A bankruptcy filing would halt proceedings in the lawsuits and allow Purdue to negotiate with plaintiffs under the watch of a bankruptcy judge...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.

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

Food and Drug Commissioner Scott Gottlieb...resigned...effective in about a month...The 46-year-old physician, millionaire and cancer survivor known for a self-assured, sometimes brash, manner lives in Westport, with his wife and three daughters – 9-year-old twins and a 5-year-old...“It was a very hard decision,” Gottlieb said in an interview. “This is the best job I will ever have. I’m leaving because I need to spend time with my family. I get home late Friday, work on weekends and come back to Washington on Sunday. I did the job 100 percent."...The resignation took some senior FDA officials by surprise, and came as Gottlieb’s signature issue – youth vaping – is being reviewed by the White House Office of Management and Budget. The plan, detailed by Gottlieb last fall, would sharply restrict the sale of flavored e-cigarettes to curb a surge in underage vaping, which he argues could lead to a whole new generation addicted to nicotine...READ MORE