We’re reading about tariffs and drug costs, Trump drug safety cuts

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop the world from spinning. So this means one thing: time to dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. Meanwhile, we have also fired up the coffee kettle for another cup of stimulation. Our choice today is Mexican cinnamon. We hope your day is simply smashing and, as always, do keep in touch if something saucy arises. …

Confusion over the U.S. Food and Drug Administration delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when agency commissioner, Marty Makary, took to social media to defend the FDA’s controversial handling of the company’s submission, STAT tells us. In the process, Makary and a spokesman for the U.S. Department of Health and Human Services appeared to raise the specter that, going forward, manufacturers of Covid vaccines might have to generate new effectiveness data before the release of annual updates of their vaccines — a hurdle they would be unlikely to clear to vaccinate people in time to protect them when Covid transmission is occurring. On Friday, The Wall Street Journal reported the FDA is asking Novavax to conduct a new randomized controlled trial, a step that would cost the company tens of millions of dollars and delay by months if not longer full approval of the vaccine. The agency was supposed to decide by April 1 on the Novavax application for a full license for its vaccine.

Pharmaceutical companies in China are reporting that they have been able to import some drugs over the past week with tariff exemptions, the American Chamber of Commerce in Beijing said on Friday, according to Reuters. The move, if confirmed, could be a sign that Chinese authorities are prepared to be flexible to try to mitigate the impact of an ongoing U.S.-Chinese trade war. Big pharmaceutical companies including AstraZeneca, Johnson & Johnson, and Merck have at least one manufacturing site in the U.S. for drugs sold in China, according to Chinese government data. “Anecdotally, companies are reporting that they are able to bring in some items without tariffs,” Michael Hart, the chamber’s president, said during an online press conference in Beijing. However, he added, “It’s pharmaceutical firms on the exemptions, but I believe it is drug-specific and not a sector-wide exemption.”