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Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The United States Drug Enforcement Administration and Dutch law enforcement officials...announced sustained action against drug trafficking on the dark web, following last summer’s significant market takedowns of AlphaBay and takeover and subsequent takedown of the Hansa market. DEA continued to partner with the National Police of the Netherlands...to identify individuals who purchase drugs on the dark web and to further disrupt dangerous drug trafficking. Further examination of the Hansa Market data revealed illicit drug purchase information identifying U.S. and Dutch individuals, resulting in numerous face-to-face doorstep visits by police to suspected opioid buyers throughout the U.S. and the Netherlands...AlphaBay operated as a hidden service on the “Tor” network, and utilized cryptocurrencies including Bitcoin, Monero and Ethereum in order to hide the locations of its underlying servers and the identities of its administrators, moderators, and users. Based on law enforcement’s investigation of AlphaBay, authorities believe the site was also used to launder hundreds of millions of dollars deriving from illegal transactions on the website...the Hansa Market, another prominent dark web market...was used to facilitate the sale of illegal drugs, toxic chemicals, malware, counterfeit identification documents, and illegal services. The administrators of Hansa Market, along with its thousands of vendors and users, also attempted to mask their identities to avoid prosecution through the use of Tor and digital currency.

Canopy Growth Corp, one of the world’s biggest medical marijuana producers, now wants to take on the world’s pharmaceutical giants...The Canadian firm launched Canopy Health Innovation in late 2016 to build a portfolio of patented and federally approved cannabinoid-based medicines...aiming to compete with established drugs treating diseases ranging from anxiety and chronic pain to multiple sclerosis and childhood epilepsy...They’re developing research-backed formulations to be sold as pills, inhalers, solutions and creams, with the goal of convincing doctors and insurers to embrace marijuana as a mainstream medicine...Canopy Health and other firms now aim to craft new formulations with varying cannabinoid levels; to find the best dosage delivery systems, such as rapid-release or long-acting tablets or metered-dose inhalers; or to combine cannabinoids with other drugs or supplements to improve effectiveness...Medical marijuana firms have an unusual advantage in that they can continue to sell a legal but largely unregulated medicine as they raise money for research into fully regulated products that might have “enormous potential” in the pharmaceutical market...“We’re allowed to sell a product that many people view as being a possible replacement for many pharmaceutical products,” he said. “But we’re not obligated to take it through the traditional Health Canada approval process.”

Debate over about 'how to price a cure' entered the pharma industry lexicon when Gilead Sciences Inc. priced its highly effective hepatitis C drug Sovaldi (sofosbuvir) at $84,000 per treatment course...The uproar has died down a bit and there's now much less debate about whether Sovaldi was actually cost effective. It has since been shown the drug could save the health system millions by helping to prevent hepatitis C patients from progressing to liver failure...“Gilead bought a launch-ready drug ... and so they launched very quietly,"..."But any analysis that you run shows it's very cost-effective. And I don't think they had to do any discount scheme until after other competitors launched. So one could say that they had a good product and a good story, but they did not tell it."...Gilead...has tried to squeeze every dollar out of the franchise before falling new patient starts and competition erodes away its market. All told, the four antiretrovirals Gilead developed on the sofosbuvir backbone have earned the company roughly $55 billion since Sovaldi's approval in 2013...

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

The Food and Drug Administration plans to use a proposed $400 million boost in federal funding to focus on a range of innovative approaches to speed the approval of new medical devices and create a new center that would support digital health oversight and address cybersecurity concerns...FDA Commissioner Scott Gottlieb, announced...That would include specific carve-outs planned for a new Center of Excellence on Digital Health and furthering the agency’s ability to use EHR data to evaluate medical devices...The Center for Excellence on Digital Health would oversee a revamped regulatory paradigm created through the FDA’s new software precertification program launched with nine companies in September. But the center would also create a cybersecurity unit to “enhance its ability to coordinate device-specific responses to cybersecurity vulnerabilities and incidents.” Over the past several years, medical device cybersecurity has emerged as particular concern for industry and regulators...Gottlieb also highlighted an expanded effort to integrate real world data into pre-market and post-market reviews of drugs and medical devices. The additional funding would allow FDA to develop analytic tools and pull real-time data out of EHRs associated with at least 10 million individuals across a range of healthcare settings...“Toward these ends, an expanded use of natural language processing for the assessment of information submitted to the agency would be developed in an effort to markedly speed recognition and remediation of emerging safety concerns,” he said. “The effort would cover a broad range of medical products, including drugs, biologics and medical devices.”

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

While industry watchers were eagerly anticipating Amazon’s move into prescription drugs, the e-commerce behemoth snuck into over-the-counter sales with help from store brand expert Perrigo...Amazon rolled out a line of consumer health products, called Basic Care...The portfolio—consisting of 60 Perrigo-made treatments—sets Amazon up to put the squeeze on retailers of OTC therapies...Amazon already sells branded OTC products...including those from Perrigo’s GoodSense brand...But with Basic Care, Amazon can undercut its competition to reap just a hair in the profit margin column...just because Amazon’s got the lowest prices doesn’t mean consumers will consistently order the Perrigo brands online instead of running out to a Walgreens or CVS when they need something.

Grocery chain Albertsons announced plans...to acquire Rite Aid, as the traditional grocery industry continues to look for growth by broadening offerings, not just store base...A combined Albertsons and Rite Aid would have a value of roughly $24 billion, including debt. When the deal closes, Albertsons shares will trade on the New York Stock Exchange...Rite Aid will own a 28 percent to 29.6 percent stake in the combined company and current Albertsons shareholders will own a 70.4 percent to 72.0 percent, on a fully diluted basis...The two will have about 4,900 locations, 4,350 pharmacy counters and 320 clinics...Most Albertsons' pharmacies will be rebranded as Rite Aid, and the company will continue to operate Rite Aid's stand-alone stores...The deal with Albertsons underlines the change in course that retailers are taking, no longer looking to expand only by real estate footprint, but also by capability. Increasingly, retailers are looking to pharmacies for this expansion, which can take advantage of the frequency with which people buy prescription drugs. There is also the opportunity to use store footprints as a base for drug delivery and pick up...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.