Bloomberg Intelligence analysts Duane Wright and Aude Gerspacher look ahead in this edition of the Votes and Verdicts podcast and talk about key policy, regulatory and litigation issues to watch in the therapeutics sector. They discuss the implementation and legal hurdles for Inflation Reduction Act (IRA) drug pricing, the outlook for Medicare’s obesity drug coverage, the 340B drug-discount program and other far-reaching industry issues.

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Merger guidelines used by the Federal Trade Commission and Department of Justice to assess the antitrust impact of transactions were updated and revised in 4Q. In this episode of the Votes and Verdicts podcast, Edelman Smithfield Managing Director Ira Gorsky joins Bloomberg Intelligence analyst Jennifer Rie to discuss the implications of several of the changes. They focus on areas of the guidelines that significantly depart from past iterations, which may raise a range of new issues for companies contemplating a transaction, and likely broaden the scope of antitrust enforcement of M&A.

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Bloomberg Intelligence analysts Elliott Stein and Nathan Dean hosted Eugene Scalia, former Secretary of Labor and current Administrative Law and Regulatory Practice Group co-chair at Gibson Dunn, to discuss lawsuits challenging government regulations. The conversation included a discussion of Chevron deference, the Basel III endgame, SEC and California climate disclosure laws and the SEC’s private funds rule.

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Cell and gene therapies are a scientific advancement that can treat previously uncurable diseases. Yet absent a national coverage and payment framework, they will remain out of reach for patients, according to Amanda Katchmar and Alan Cohen from Boston University. They join Bloomberg Intelligence analysts Duane Wright and Ann-Hunter Van Kirk on this episode of the Votes & Verdicts podcast to discuss the pipeline for cell and gene therapies and the coverage and reimbursement outlook.

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Regulatory and enforcement review of the Synopsys-Ansys and Capital One-Discover deals, finalized PFAS rules by the EPA, and the SEC’s climate disclosure rule are important March catalysts to watch. This Bloomberg Intelligence litigation and policy outlook episode, hosted by financials litigation analyst Elliott Stein, gathered the team to discuss these and other catalysts. In addition, Meta’s suit challenging the FTC plan to toughen terms of the social-media giant’s $5 billion 2020 settlement is teed up for a key March 1 hearing, and a ruling is likely by March 15. Danske Bank, Deutsche Bank and Standard Chartered will be in an appeals court on March 13 to argue for preserving dismissal of a suit by US servicemembers and their families alleging the banks facilitated transfers of millions of dollars to terrorists in Afghanistan. We also reviewed health-insurer earnings and the impact US elections might have on the drug-pricing provisions of the Inflation Reduction Act.

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As federal action to reschedule, legalize or otherwise regulate the marijuana trade lingers, legitimate cannabis operations in states where pot is now legal continue to face significant barriers to programs and services, largely because the federal Controlled Substances Act still outlaws the drug. Among the many hurdles encountered by these businesses are a lack of access to federal tax credits and difficulty doing regular business with banks and credit card companies. Josh Schiller, Partner at Boies, Schiller & Flexner LLP, joins BI litigation and policy analysts Justin Teresi and Nathan Dean to discuss his constitutional challenge to the Controlled Substances Act brought on behalf of Massachusetts cannabis growers, packagers and retailers — centered on the argument that Congress can’t use the Interstate Commerce Clause to interfere with what’s now an entirely intrastate trade.

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The Biden administration has proposed to extend medical-device oversight to laboratory developed tests. But doing so could increase compliance costs for test developers and reduce patient access to widely used tests, according to Susan Van Meter, President of the American Clinical Laboratory Association. She joins Bloomberg Intelligence analyst Duane Wright on this episode of the Votes & Verdicts podcast to discuss how the FDA’s existing framework for regulating medical devices is ill-suited for LDTs, why the Biden proposal should be withdrawn and a legislative approach to modernizing oversight of all clinical lab tests, including LDTs.

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The Biden administration’s proposal to expand the Bayh-Dole march-in framework to include price as a factor in determining that a drug isn’t accessible to the public could change collaboration agreements between universities and biotech companies. But the effort is inconsistent with the legislative intent of the framework, according to Joe Allen, executive director of the Bayh-Dole Coalition. He joins Bloomberg Intelligence analysts Duane Wright and Tish Walker on this episode of the Votes & Verdicts podcast to discuss why price shouldn’t be a factor for march-in rights, and the implications for federally supported research and development if its is.

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Apple’s choices to deal with an Apple-Watch import ban, a key hearing in Arbutus v. Moderna Covid-19 patent litigation, and more trials and a critical appeal in Bayer litigation over weed-killer Roundup are important February catalysts to watch. This Bloomberg Intelligence litigation and policy outlook episode, hosted by financials litigation analyst Elliott Stein, gathered the team to discuss these and other developments. They’ll also look at this month’s court cases, including private equity firms and hedge funds’ challenge to the SEC’s private-funds rule, and Supreme Court arguments over whether states can force internet companies like Google and Meta to carry content.

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The US Supreme Court this month refused to consider Apple’s appeal in an antitrust suit challenging its App Store. In this Votes & Verdicts episode, NYU Law Professor Harry First and Bloomberg Intelligence analysts Jennifer Rie, Anurag Rana and Tamlin Bason discuss the Epic Games v. Apple litigation and other antitrust risks Apple is facing in the US and the EU. They also look at Apple’s plans for compliance with the injunction issued by the court in the Epic Games suit, and Apple’s indirect role in a Department of Justice suit against Google over search. Rana outlines how antitrust activities could affect Apple’s business.

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