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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

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

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

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

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

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 lady Melania Trump is asking the public to look beyond the raw numbers and to see the opioid crisis as a "human story."...Mrs. Trump says that by thinking of the faces behind the statistics "we have the potential to not just reduce, but eliminate" the tens of thousands of deaths that are attributed to opioids annually. Federal statistics show that nearly 48,000 Americans died in 2017 after overdosing on the powerful painkillers...The first lady spoke Tuesday during a town hall-style conversation in Las Vegas on the opioid epidemic. She is using the event to close a two-day, three-state tour to promote her "Be Best" initiative, which includes a focus on babies born dependent on opioids...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

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

The legislation, which GOP Assembly members Melissa Hardy and Glen Leavitt presented to the Assembly Commerce and Labor Committee on Monday, would bar pharmacy benefit managers, or PBMs, from stopping a pharmacist from telling patients about the availability of a less expensive, generic or more effective drug, or a less expensive manner of purchasing a drug. The proposal builds upon a pharmacy gag ban passed by the Legislature in 2017 that prevented PBMs from blocking pharmacists from sharing information about the copay or coinsurance for a prescription drug or the clinical efficacy of a less expensive alternative drug...READ MORE