‘Skinny Labels’ Court Ruling May Complicate Generic Drug Sales
Stat reports on a recent federal appeals court ruling about how generic drug makers can market their products. Modern Healthcare, meanwhile, reports on how health insurers allegedly use biologic shortage to boost biosimilars. Junk DNA, audits, PPE and FEMA are also in the news.
Stat:
A Federal Appeals Court Throws Into Question The Fate Of 'Skinny Labels' — And Access To Generic Drugs
In a decision with enormous implications for the U.S. health care system, a federal appeals court panel issued a ruling that throws into question the ability of generic companies to “carve out” uses for their medicines and supply Americans with lower-cost alternatives to pricey brand-name drugs. At issue is skinny labeling, which refers to an effort by a generic company to seek regulatory approval to market its medicine a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement. (Silverman, 8/5)
Modern Healthcare:
Health Insurers Allegedly Use Biologic Shortage To Promote Biosimilars
The American Academy of Ophthalmology has accused large health insurers of using a biologic drug shortage as a means to push patients into using biosimilars for a common retina disease, even though the drugs haven't been tested for that use. The San Francisco-based lobbying 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 some cancers. The industry group has asked CMS to stop insurers from pressuring patients to take biosimilars Zirabev from Pfizer and Mvasi from Amgen for age-related macular degeneration, which is the leading cause of blindness in individuals over 60 and affects approximately 15 million people in the U.S. (Tepper, 8/5)
Stat:
Researchers Plumbing Mysterious RNAs Find A Possible Treatment
When hundreds of scientists from around the world finally pieced together a draft of the first human genome in 2003, perhaps the biggest surprise was just how little of it was devoted to the business of producing proteins. About 98% of the genes in our chromosomes appeared not to do anything, earning the unflattering nickname “junk DNA.” But with better tools developed over the last 20 years, scientists began to discover that all that junk actually produces a diverse menagerie of RNA species transcribed and set loose to drift around the cell. (Molteni, 8/5)
KHN:
Pharmacies Face Extra Audit Burdens That Threaten Their Existence
The clock was about to strike midnight, and Scott Newman was desperately feeding pages into a scanner, trying to prevent thousands of dollars in prescription payments from turning into a pumpkin. As the owner of Newman Family Pharmacy, an independent drugstore in Chesapeake, Virginia, he was responding to an audit ordered by a pharmacy benefit manager, an intermediary company that handles pharmacy payments for health insurance companies. The audit notice had come in January as he was scrambling to become certified to provide covid-19 vaccines, and it had slipped his mind. Then, a month later, a final notice reminded him he needed to get 120 pages of documents supporting some 30 prescription claims scanned and uploaded by the end of the day. “I was sure I’d be missing pages,” he recalled. “So I was rescanning stuff for the damn file.” (Hawryluk, 8/6)
And in updates on the availability of PPE —
Axios:
McKesson, Cardinal Stuck With A Glut Of Personal Protective Equipment
McKesson and Cardinal Health are sitting on huge inventories of personal protective equipment, some of which they estimate won't be used or will expire, resulting in a $164 million loss for McKesson and a $197 million loss for Cardinal in the second quarter. Last year, during the height of the pandemic, PPE was in high demand but short supply, leading to high prices and long waits. Now that supply has caught up, some medical distributors have too much and believe a lot will go unsold, although McKesson said it would donate some of its excess PPE. (Herman, 8/6)
NBC News:
Trump-Appointed Inspector General Blames FEMA — Not Task Force — For PPE Chaos
An inspector general found that data management problems hampered the Federal Emergency Management Agency's distribution of personal protective equipment during the early days of the Covid-19 pandemic, according to a draft of the soon-to-be-released report obtained by NBC News. The report from Department of Homeland Security Inspector General Joseph Cuffari, an appointee of former President Donald Trump, places blame on the nation's primary disaster response agency, rather than at the feet of the White House Coronavirus Task Force officials who ultimately had authority for the acquisition and distribution of the resources. (Allen, 8/5)
