When my family and I moved to rural America from Armenia in the mid-1990s, we found that it stood true to its reputation as the land of opportunity and abundance. Work was readily available, and my parents also found opportunities to pursue other sources of income through self-employment, contracting and starting their own businesses.

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This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, how disasters drove its expansion and regulatory oversight, and how the epidemic of the human immunodeficiency virus (HIV) changed the approval processes.

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This is the first in what will be a series of posts discussing how new medicines are introduced and regulated in the United States, and how the status quo could be improved. As will be established over the course of the series, the current system is slow and leads to poor outcomes for patients.

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Reading comments (Ben Thompson, Eric Seufert) on the Meta-Amazon deal to let “shoppers buy Amazon products directly from ads on Instagram and Facebook” (Bloomberg) made me think: could it happen here (in the EU)? Would EU law block it? I don’t think so. Still, given that the deal means “more data for Meta” (and Amazon), we’ll likely see some knee-jerk critical reactions. So, I thought it would be interesting to think through this question. (To be clear: this is not a full legal analysis, just my quick thoughts).

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Amazon against the DSA ad database duty: The new Digital Services Act (DSA) includes a duty for very large online platforms (VLOPs) to “compile and make publicly available an advertisement repository.” Amazon challenged this duty before the EU’s General Court, which made a preliminary decision to temporarily suspend the application of that duty to Amazon.

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The Biden administration’s Oct. 30 “Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence” proposes to “govern… the development and use of AI safely and responsibly” by “advancing a coordinated, Federal Government-wide approach to doing so.” (Emphasis added.)

This “all-of-government approach,” which echoes the all-of-government approach of the 2021 “Executive Order on Competition” (see here and here), establishes a blueprint for heightened regulation to deal with theorized problems stemming from the growing use of AI by economic actors. As was the case with the competition order, the AI order threatens to impose excessive regulatory costs that would harm the American economy and undermine competitive forces. As such, the order’s implementation warrants close scrutiny.

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Here in New Jersey, where I live, the day before Halloween is commonly celebrated as “Mischief Night,” an evening of adolescent revelry and light vandalism that typically includes hurling copious quantities of eggs and toilet paper.

It is perhaps fitting, therefore, that President Joe Biden chose Oct. 30 to sign a sweeping executive order (EO) that could itself do quite a bit of mischief. And befitting the Halloween season, in proposing this broad oversight regime, the administration appears to be positively spooked by the development of artificial intelligence (AI).

The order, of course, embodies the emerging and now pervasive sense among policymakers that they should “do something” about AI; the EO goes so far as to declare that the administration feels “compelled” to act on AI. It largely directs various agencies to each determine how they should be involved in regulating AI, but some provisions go further than that. In particular, directives that set new reporting requirements—while ostensibly intended to forward the reasonable goal of transparency—could end up doing more harm than good.

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How did you come to be interested in the regulation of digital markets?

Prior to joining Levy & Salomão Advogados, I worked with the Brazilian government for nine years, four of which I served as head of the government agency in charge of antitrust enforcement and consumer protection policy. During this time, I was very lucky to participate in the early beginnings of the policy discussions on the need for enforcement in digital markets. Also, for a long time, this has been a very popular dinner conversation topic at home: my husband is in the software business and my stepdaughter is a computer engineer.

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With yet another win for NetChoice in the U.S. District Court for the Northern District of California—this time a preliminary injunction granted against California’s Age Appropriate Design Code (AADC)—it is worth asking what this means for the federally proposed Kids Online Safety Act (KOSA) and other laws of similar import that have been considered in a few states. I also thought it was worthwhile to contrast them with the duty-of-care proposal we at the International Center for Law & Economics have put forward, in terms of how best to protect children from harms associated with social media and other online platforms.

In this post, I will first consider the Bonta case, its analysis, and what it means going forward for KOSA. Next, I will explain how our duty-of-care proposal differs from KOSA and the AADC, and why it would, in select circumstances, open online platforms to intermediary liability where they are best placed to monitor and control harms to minors, by making it possible to bring products-liability suits. I will also outline a framework for considering how the First Amendment and the threat of collateral censorship interacts with such suits.

Read the full piece here.