Skinny Labels court ruling could complicate generic drug sales


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Stat reports on a recent Federal Court of Appeal ruling on how generic drug makers can market their products. Modern Healthcare, meanwhile, explains how health insurers allegedly use the shortage of biologics to boost biosimilars. Junk DNA, audits, PPE and FEMA are also in the news.

Stat: Federal appeals court questions fate of “thin labels” and access to generic drugs

In a decision with huge implications for the U.S. health care system, a Federal Court of Appeals panel has released a ruling that calls into question the ability of generic manufacturers to “exclude” the uses of their drugs and to provide Americans have cheaper alternatives to expensive brands. -name the drugs. The problem is skinny labeling, which refers to an effort by a generic manufacturer to gain regulatory approval to market their drug for a specific use, but not for other patented uses for which a brand name drug is. prescribed. For example, a generic drug might be marketed to treat one type of heart problem, but not another. In doing so, the generic manufacturer seeks to avoid lawsuits for patent infringement. (Silverman, 8/5)

Modern healthcare: Health insurers would use biologics shortage to promote biosimilars

The American Academy of Ophthalmology has accused major health insurers of using a shortage of biologics as a way to pressure patients to use biosimilars for common retinal disease, even though the drugs have not been tested. for this use. The San Francisco-based lobby group called on seven health insurers to stop recommending the use of two biosimilars for Genentech USA’s Avastin, a biologic drug used to treat eye diseases such as age-related macular degeneration and certain cancers. Industry group asked CMS to stop insurers from pressuring patients to take Pfizer’s Zirabev and Amgen’s Mvasi biosimilars for age-related macular degeneration, which is the leading cause of blindness in people over 60 and affects approximately 15 million people in the United States (Tepper, 8/5)

Stat: Researchers Studying Mysterious RNA Find Possible Cure

When hundreds of scientists around the world finally pieced together a rough sketch of the first human genome in 2003, perhaps the biggest surprise was how little it was devoted to protein production. About 98% of the genes in our chromosomes seemed to do nothing, which earned them the unflattering nickname ‘junk DNA’. But with better tools developed over the past 20 years, scientists have started to discover that all this junk actually produces a diverse menagerie of transcribed RNA species and lashes out to drift around the cell. (Molteni, 8/5)

KHN: Pharmacies face additional audit burdens that threaten their existence

The clock was about to strike midnight, and Scott Newman was desperately stuffing pages into a scanner, trying to keep thousands of dollars in prescription payments from turning into a pumpkin. As the owner of Newman Family Pharmacy, an independent pharmacy in Chesapeake, Va., He was responding to an audit ordered by a Pharmacy Benefits Manager, an intermediary company that manages pharmacy payments for health insurance companies. The audit notice had come in January as he struggled to obtain certification to supply covid-19 vaccines, and it had escaped his notice. Then, a month later, a last notice reminded him that he had to scan and download 120 pages of documents justifying about thirty prescription requests by the end of the day. “I was sure I would miss pages,” he recalls. “So I was rescanning stuff for this damn file.” (Hawryluk, 8/6)

And in the updates on the availability of PPE –

Axios: McKesson, Cardinal stuck with plethora of personal protective equipment

McKesson and Cardinal Health have huge stocks of personal protective equipment, some of which they believe will not be used or expire, resulting in a loss of $ 164 million for McKesson and a loss of $ 197 million for Cardinal in the second trimester. Last year, at the height of the pandemic, PPE was in high demand but scarce, leading to high prices and long waits. Now that the supply has caught up, some medical distributors are running out of it and believe many will not be sold, although McKesson has said it will donate some of its excess PPE. (Herman, 8/6)

NBC News: Trump-appointed Inspector General blames FEMA – not task force – for PPE chaos

Inspector General has found data management issues hampering the distribution of personal protective equipment by the Federal Emergency Management Agency during the early days of the Covid-19 pandemic, according to a draft report soon to be published obtained by NBC News. Home Security Inspector General Joseph Cuffari’s report, appointed by former President Donald Trump, blames the main national disaster response agency, rather than at the feet of task force officials on the White House coronavirus who ultimately had the authority for the acquisition. and the allocation of resources. (Allen, 8/5)

This is part of the KHN Morning Briefing, a summary of coverage of health policies by major news organizations. Sign up for an email subscription.

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