PDA - Parenteral Drug Association’s Post

The FDA is about to get sued over and over again! The Supreme Court just overturned the Chevron deference standard: https://lnkd.in/ecusGRb8 This basically upends the FDA's way of doing business!! Expect a flood of litigation!! Obviously, I will put something together on what this means for FDA-regulated companies. #FDA #clinicaltrials #drugadvertising #clinicalresearch

Professionals should make themselves knowledgeable about the possible impact this decision will have on many industries. This article goes into a bit more detail concerning said impacts --> https://lnkd.in/e98d2s2d

The Chevron Doctrine has long been a cornerstone in modern regulation creation and administrative law, providing deference to Federal agencies as experts in cases of Congressional law ambiguity. Today's Supreme Court ruling curtailing federal agencies' power may have a significant impact on regulatory trends within the industry. This decision could lead to heightened scrutiny of law interpretations and potentially hinder the timely passage of regulations. Stay informed on this evolving landscape. #RegulatoryTrends #ChevronDoctrine #SupremeCourtRuling Read more about this major ruling here: https://lnkd.in/eGj-aVRD Link to Opinion: https://lnkd.in/eztsQWPA

Check out this important paper by Dhillon partner Gary Lawkowski about protecting average citizens from criminal regulations they could never expect to exist.

Thanks for sharing Shannon Bennett! No surprise this was a 6-3 vote. For better or worse, certainly consistent with this court's proclivities. For a slightly more detailed review, I found this helpful from SCOTUSblog: https://lnkd.in/gWATs2gA A few excerpts that caught my attention: 1. Roberts rejected any suggestion that agencies, rather than courts, are better suited to determine what ambiguities in a federal law might mean. Even when those ambiguities involve technical or scientific questions that fall within an agency’s area of expertise, Roberts emphasized, “Congress expects courts to handle technical statutory questions” – and courts also have the benefit of briefing from the parties and “friends of the court.” Moreover, Roberts observed, even if courts should not defer to an agency’s interpretation of an ambiguous statute that it administers, it can consider that interpretation when it falls within the agency’s purview, a doctrine known as Skidmore deference. 2. Kagan, who read a summary of her dissent from the bench, was sharply critical of the decision to overrule the Chevron doctrine. Congress often enacts regulatory laws that contain ambiguities and gaps, she observed, which agencies must then interpret. The question, as she framed it, is “[w]ho decides which of the possible readings” of those laws should prevail? For 40 years, she stressed, the answer to that question has generally been “the agency’s,” with good reason: Agencies are more likely to have the technical and scientific expertise to make such decisions. But more broadly, Kagan rebuked her colleagues in the majority for what she characterized as a judicial power grab. 3. And then there's this: The fishermen in both cases were represented at no cost by conservative legal groups, the Cause of Action Institute and the New Civil Liberties Alliance, linked to funding from billionaire and longtime anti-regulation advocate Charles Koch. The potential impact of this ruling on federal agencies (FDA, CMS, EPA, SEC, and the list goes on and on) is breathtaking . . .

Another nail in the coffin of democracy in USA and globally is coming. The Supreme Court is open to overturning the Chevron Doctrine - the doctrine gives power to govt agencies to decide on matters of regulation instead of Courts in areas requiring application of expertise where the law may not be clear totally. Overturning the Chevron document would mean a significant blow e.g to environmental regulations and other types of regulations with big business being able to take most matters to Court and in front of favourable judges to get decisions that favour them on regulation. This case is not in the spot light but will have massive impact - so instead of experts making assessments on policy and regulation matters, Judges with no subject matter expertise on say the environment, or chemicals or similar making such decisions. The crumbling of democracy continues. ..without democracy there is no economy. https://lnkd.in/gw99Bk8R

Introducing our Fourth Panel of Day 2 who will led you through "Regulatory control and Litigation as a result of abuse of Dominant Position." Register and get your tickets at: https://lnkd.in/dk7_qRUV

With all the concerns today about the cost of living crisis, competition authorities have had plenty of appetite to start new antitrust investigations, and the number of dawn raids remains high in Q1 2024. Check out the new edition of White & Case’s Dawn Raids Analysis Quarterly here for the latest developments: https://ow.ly/1BE750Rl36l #DRAQ #dawnraids #antitrust

See the latest analysis of the statute of limitations for APA actions. In light of the demise of Chevron deference, we can certainly expect more litigation related to administrative agency actions. Stay tuned!