- CVS pulls Zantac and generics as recall spreads around the globe (fiercepharma.com)FDA says finds 'unacceptable level' of carcinogen in Zantac and its generics (reuters.com)
The Zantac recall is quickly turning into a landslide as CVS pulled Zantac and its generics from its shelves and countries from Korea to Bangladesh asked makers to remove ranitidine drugs from their markets...CVS Sunday said it was suspending sales of all Zantac brand and CVS Health brand ranitidine products until further notice. That came despite the fact the FDA has yet to seek the recall of the products or recommend that patients quit taking the heartburn med after it warned a suspected carcinogen has been found in them...FDA alerted the public Sept. 13 that it had been determined that NDMA could be produced during the manufacturing of ranitidine drugs. At the time, it said the amounts found in the drugs appeared to be less than would be found in common foods, and their risks seemed small...READ MORE
- Top Pelosi aide to payers: Help us defeat Big Pharma (biopharmadive.com)
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
- This Week in Managed Care: September 27, 2019 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- September 27 Pharmacy Week in Review (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.
- Drugmakers look to use Purdue Pharma’s bankruptcy to settle U.S. opioid suits: WSJ (reuters.com)
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
- FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps (mobihealthnews.com)
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
- Amid a political firestorm over pharma’s pricing, net prices actually fell last quarter: report (fiercepharma.com)
Politicians and headlines regularly describe U.S. drug prices as “skyrocketing." But new data from analysts at SSR Health show prices haven't been growing as fast as they were—and the amount payers actually shell out is falling...In the second quarter, list prices in the U.S. grew 3.1%, compared with a 4.6% increase during the same period last year. After rebates, prices fell 5.8% during the second quarter, compared with a 6.1% drop after rebates during last year’s second quarter...The net pricing changes typically reflect a mix of increases and decreases across the industry—among various products, companies and market segments—but this time around, “literally no products, companies, or market segments" displayed big net price increases...READ MORE
- Endo comes out on top in its fight with FDA and bulk compounder (fiercepharma.com)
...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
- Walmart taps digital upskilling platform to prepare workers for health care jobs (chaindrugreview.com)
Penn Foster announced...that its unique upskilling platform for health care has been selected by Walmart as part of an ambitious initiative designed to prepare workers for opportunities in high-demand health professional fields. A pioneer in middle-skills training, Penn Foster’s digital platform enables employers to deliver on-demand, career-specific coursework through a blended online and work-based learning skills development program...Walmart’s 1.5 million associates in the U.S. will now be able pursue roles as opticians or pharmacy technicians through a flexible, online curriculum that costs learners just $1 per day...READ MORE
- Purdue seeks $34M in employee bonuses as bankruptcy process begins (fiercepharma.com)
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