The Biden administration’s May 5 about-face on the proposed TRIPS waiver of intellectual property (IP) protections for COVID-19-related medical products is not playing well with U.S. industry, EU trading partners and others concerned about the long-term unintended consequences.

The FDA’s Arthritis Advisory Committee panelists groped through cloudy data while complaining about the design of the phase III trial for Chemocentryx Inc.’s avacopan, and after going overtime ended up without consensus. Briefing documents ahead of the meeting darkened what had been a fairly bright picture for the complement C5a receptor inhibitor for anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, but Wall Street held out hope. Wainwright analyst Edward White opined in a May 5 report that the adcom’s outcome “could still be positive,” and a May 4 dispatch from Canaccord Genuity’s Michelle Gilson said the briefing docs “miss[ed] the big picture.”

The European Commission posted a draft legislative framework for regulation of artificial intelligence, a document that spans all potential uses of such algorithms rather than just medical ones.

Once again, the World Trade Organization (WTO) postponed a decision on a temporary intellectual property (IP) waiver for COVID-19 vaccines and other related medical products.

The 2021 Special 301 Report recently released by the U.S. Trade Representative is mostly déjà vu for the 32 countries included on the Priority Watch and Watch Lists, as all of them have appeared before on the lists that call out U.S. trading partners for unfair intellectual property practices that disadvantage foreign companies.

The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.

Nearly a week after U.S. President Joe Biden called on Congress to get prescription drug pricing reform done, a House subcommittee took up dueling bills aimed at bringing down drug prices.