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Endo International Plc, Johnson & Johnson and other drugmakers that face litigation over the opioid crisis are exploring a way to settle the cases by participating in Purdue Pharma LP’s bankruptcy...Five drugmakers battling the cases - Endo, J&J, Teva Pharmaceutical Industries Ltd, Allergan Plc and Mallinckrodt Plc - are looking to enact a global settlement of the litigation that would be implemented through Purdue’s Chapter 11 case...The mechanism, if successful, would allow the companies to contribute money into a trust set up through the bankruptcy in exchange for a complete release from liability...READ MORE

House Speaker Nancy Pelosi's senior adviser on healthcare pitched the California representative's drug plan to a ballroom full of insurance industry players...and called on them to support the bill...Wendell Primus tried to convince the crowd that a united coalition could weather pharma's influence if it included insurers, doctors, hospitals, the public and the AARP..."I have no reason to underestimate the influence of pharma in this town, and they are going to work very hard to defeat this bill," Primus said in Washington during a conference held by the insurance lobby America's Health Insurance Plans...Jennifer Bryant, senior vice president of policy and research for PhRMA, the lobbying group for the pharmaceutical industry, said the bill would give the government sweeping authority that she said should give those in the ballroom pause...READ MORE

As Purdue Pharma undertakes the laborious bankruptcy process, plaintiffs in thousands of opioid suits are looking to lock in settlement funds from the stripped-down drugmaker. Purdue—for its part—is hoping to secure incentives for its employees in the meantime...Purdue has asked permission to pay out more than $34 million in annual and long-term incentives to its employees as the company undergoes a court-supervised restructuring, according to a Chapter 11 motion filed...in the Southern District of New York...READ MORE

While insurer and hospital groups cheered House Speaker Nancy Pelosi’s new drug prices plan, other experts and groups are skeptical of the bill’s chances of ever reaching President Donald Trump...The ambitious plan...drew plaudits from hospital and pharmacy benefit manager groups and fierce opposition from pharma. But major opposition from Republican members of the GOP-controlled Senate could doom the proposal, some experts and groups said...Republicans have blasted the proposal that calls for the Department of Health and Human Services to identify up to 250 brand-name drugs that do not have a lot of competition and aren’t driving up spending...HHS would then negotiate with the makers of those drugs to determine a fair price that Medicare and commercial payers would pay. The price would be linked to an average paid by several developed countries such as Germany and France...READ MORE

...Endo International...has prevailed in its two-front fight with the FDA and bulk compounders. The resolution has ended competition for its vessel constrictor Vasostrict...The drugmaker...has dropped its litigation against the FDA...the FDA amended its draft guidelines to stop compounders from making vasopressin...While the ruling is specific to vasopressin, it is believed to have precedent for other drugmakers whose drugs are targeted by large-scale compounders for generic competition...READ MORE

FDA released two guidance documents relating to the regulation of various digital health software devices...The first is a draft guidance outlining categories of clinical decision support products that would or would not require direct regulatory oversight from the agency. This is an update to a CDS draft guidance released in 2017, with the noteworthy addition of a risk-based categorization approach for determining enforcement over these tools...The second is a final guidance that brings several existing medical software policies from the agency into accordance with provisions outlined in 2016’s 21st Century Cures Act. In particular, the document describes certain types of software products that will no longer fall within the agency’s definition of a medical device...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 U.S. Food and Drug Administration and the Drug Enforcement Administration jointly issued warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid medicines, the agencies said...The networks which were issued the warning letters...are Divyata, Euphoria Healthcare Pvt Ltd, JCM Dropship and Meds4U, which operate a total of 10 websites...The networks also violated the Controlled Substances Act by not registering the online pharmacies with the DEA despite advertising for the sale of opioids...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

As U.S. officials press a massive case for alleged generic drug price fixing, authorities in the U.K. have unearthed an example of rivals working a little too closely with each other...King Pharmaceuticals and Alissa Healthcare Research, which both sold the antidepressant drug nortriptyline, admitted to exchanging "commercially sensitive information" in order to keep prices high...The U.K.'s Competition and Markets Authority said...it had found the companies exchanged info about prices, volumes and market entry plans for their drugs...READ MORE