Drug Fix: Regulatory Nationalism And US FDA’s IND Reforms

So the news of the AstraZeneca BMS merger was a huge water cooler story on Monday morning after it broke the night before that discussions were underway.

People were genuinely excited and intrigued by the possibility of a combined company worth $400 billion.

It would have had a monster oncology portfolio, including some of the biggest franchises in the space, but the story fizzled pretty much just as quickly as it emerged.

And now reports are that the talks never happened.

So but before that, those of us in the media, as we were all considering all the issues that went along with this, including the potential problems that could arise during the regulatory review of the merger.

And part of that was the influence of nationalism and politics on this.

So President Trump, as most of our listeners know, was elected in part because of his America first policies and his promises to bring back manufacturing to the U.S., this deal would have put BMS, an American company, into the hands of a British company.

So while no one would have expected all, if any, of BMS's assets to move to the UK, the idea of an American company being combined into a foreign one may not have sat well with Trump supporters.

In fact, some of the early reactions to the deal were, could this get done politically? And some analysts wondered if that the political issue would have come out in the antitrust review.

This brings up a broader issue and we're seeing it bubble up here in interesting places.

This idea of America first, such as pushing companies to locate manufacturing here even if it's more expensive, forcing companies to charge prices for drugs in the US they give to peer countries.

The fact that we're thinking about political issues almost before we even think about actual antitrust concerns, seems to be just another illustration of how this landscape has transformed.

I'm curious what you all think of this.

This is not to say politics has never impacted a merger review before or regulation in general for that matter.

But in this case, we're not talking about losing control of advanced weaponry or a national security issue or anything like that.

The acquiring company is located in one of our closest allies.

This is Yet it's still an issue.

So I guess, Matt, I'm curious how you're viewing all of this broader issue that we saw with nationalism and politics and its relationship to regulation now.

Yeah, thanks, Derek.

It definitely would have been one issue of many had the merger concept moved forward.

uh, you know, there are plenty of other, uh, more traditional, uh, uh, antitrust hurdles that would have been in the way to, uh, given their overlapping portfolios, uh, um, et cetera.

And, uh, you know, there was obviously very little, uh, um, financial enthusiasm for the, uh, um, uh, for a deal this big, uh, between those two.

So, uh, um, uh, as you noted, it definitely wasn't your kind of, uh, um, America first concerns that sort of kind of put the brakes on it, but there was a whole, uh, number of issues.

And I think, you know, not just the pharma, but, you know, everywhere from kind of in the merger, Meilu, you've seen the Trump administration be very activist, I guess, for lack of a better word, in asserting what they want done in these transactions.

You know, the Biden administration was FTC under Lena Kahn was criticized for its aggressiveness.