- Dutch join backlash at expensive drugs by making their own (reuters.com)
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
- Purdue eyes bankruptcy filing to cope with mounting opioid accusations: Reuters (fiercepharma.com)Exclusive: OxyContin maker Purdue Pharma exploring bankruptcy -sources (reuters.com)
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
- FDA oversight of the prescribing of fentanyl products is inadequate, report finds (healthcarefinancenews.com)Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products (jamanetwork.com)
The Food and Drug Administration and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients, new research...shows...even as evidence emerged that as many as half of patients were taking dangerous medications known as TIRFs that should never have been prescribed to them, the FDA and fentanyl makers did not review prescribing records of even a single physician to consider disqualifying them from the program, which would have prevented them from prescribing the products...The study focused on Transmucosal Immediate-Release Fentanyls, or TIRFs, which are more dangerous than most prescription opioids on the market due to their very high potency and rapid onset. TIRFs are designed to get into the bloodstream within seconds, and because of their risks, were approved by FDA only for adult cancer patients "who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain."
- Expired drugs may remain effective, safe to use in a pinch (reuters.com)Expired Drugs in the Remote Environment (wemjournal.org)
Even medicines that are years past their expiration date and haven’t always been kept in strict climate-controlled conditions may still retain their original potency, a small study suggests...That is good news for people working in remote areas of the world where sometimes an expired medication is the only one available and the alternative is having no way to treat a serious illness...This date is not necessarily the point at which the drug becomes ineffective or dangerous, and for many medications, this window may be far longer than the usual two-to-three-year expiry date...The study team tested the stability of five expired drugs that had been returned from the British Antarctic Survey...They tested five types of drug, all one to four years past expiration, and compared these to fresh samples of the same medications to see if the expired versions were chemically stable and retained their active ingredient...Researchers found that all of the tested drugs were stable, and would, theoretically, have still been effective...
- Lilly answers insulin price-hike critics with 50% off Humalog generic (fiercepharma.com)
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
- This Week in Managed Care: March 1, 2019 (ajmc.com)
, welcome to This Week in Managed Care from the Managed Markets News Network
Jaime Rosenberg - Congressman aims to break pharma’s insulin ‘pricing monopoly’ by legalizing Canadian imports (fiercepharma.com)
U.S. legislators have been introducing bills left and right proposing a variety of methods for bringing down drug prices. Now, Vermont's congressman is zeroing in on a specific class of diabetes medicines that he says have become far too expensive: insulin...Rep. Peter Welch introduced a bill on Wednesday that would make it legal for patients, wholesalers and pharmacists to import insulin from Canada, and eventually from other countries with acceptable safety standards...Welch clearly wants to make an end run around Lilly and its fellow insulin makers. If his bill were to become law, patients with valid prescriptions would be able to import low-cost insulin and have it covered by their insurance plans...
- FDA warns CanaRx to stop selling unapproved medicines in the US (pharmaceutical-technology.com)
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
- Executives from seven major drug companies will be grilled about the high cost of their medications at a Senate panel on Tuesday morning. (ksat.com)
The hearing is the latest volley in Washington's battle against soaring drug prices, which has become a top priority for the Trump administration, as well as many Democratic and some Republican lawmakers...Executives from companies including Pfizer, Johnson & Johnson and AbbVie, will appear before the Senate Finance Committee and likely face tough questions from the panel's new chairman, Republican Sen. Chuck Grassley of Iowa...
- February 22 Pharmacy Week in Review: Blood Glucose Test Strips Prove Accurate, Chronic Inflammatory Diseases Linked to Cancer (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.