FDA dithering on pharma patents, WHO pandemic talks

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation. Our choice today is honey almond. Please feel free to join us. Meanwhile, we have once again assembled a few items of interest for you. Best of luck on your journey today and, of course, do keep in touch. …

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA, STAT explains. For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency registry. Known as the Orange Book, it holds a key, behind-the-scenes role in shaping the competitive landscape of the pharmaceutical industry. But even though there has been long-running uncertainty about patent claims that should be listed for drug-and-device products, the FDA has failed to provide any clarity.

The World Health Organization’s Intergovernmental Negotiating Body failed to reach consensus on a pandemic agreement last Friday, the last scheduled day of negotiations before the upcoming World Health Assembly, Health Policy Watch says. But the INB delegates resolved to continue talks right up to the eve of the WHA, which begins on May 27. A key outstanding issue is a proposed Pathogen Access and Benefit-Sharing System, which was proposed to help countries share pathogens and genetic sequence data more quickly, and also better ensure equitable access to pandemic-related products and other benefits. The pharmaceutical industry has haggled over the proposed formula.

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