Connected With Latham

The pharmaceutical industry has seen major legal and policy changes in recent years, from the Inflation Reduction Act to the Trump administration's aggressive pricing policies. In this episode of Connected With Latham, Mike Domanico, a pharmaceutical industry veteran with experience in Big 4, brand drugs, biosimilars, and generics, and most recently Vice President of Revenue Finance, joins Washington, D.C. partner Chris Schott and associate Danny Machado to discuss how organizations can best respond to the changing environment. As Mike explains, think of meeting the challenge as a loop that connects the business, compliance, and legal in a cross-functional collaboration. Also check out our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Recent FDA actions are reshaping key aspects of drug and biologic development, including the Commissioner's National Priority Voucher program, the "plausible mechanism" pathway for personalized therapies, and new draft guidance aimed at streamlining biosimilars and interchangeables. Join Washington, D.C. partner Nathan Beaton and counsel Monica Groat and Chad Jennings as they discuss how these moves differ from traditional policy-making, as well as the practical implications for pricing, manufacturing, M&A, and litigation risk in the healthcare and life sciences industry.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Government pricing assessments are an important tool to help pharmaceutical manufacturers review their government price reporting function. They can also help uncovering strategic benefits and opportunities. In this episode of Connected With Latham, Eliza Biedziak, Managing Director at Ernst & Young LLP, joins Washington, D.C.  partner Chris Schott and associate Danny Machado to explore how these assessments are conducted, the compliance benefits they offer, and the strategic insights they can provide. Also check out our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

The new FDA Commissioner's National Priority Voucher (CNPV) pilot program promises to reduce recipients' application review times from 10-12 months to just 1-2 months. As part of the Trump administration's push for most favored nation (MFN) pricing, drug affordability is one criterion for vouchers, marking FDA's entry into the drug pricing fray. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott and counsel Monica Groat explore the voucher awards in detail and discuss how the accelerated review period might affect launch strategies, whether companies with no voucher will be disadvantaged, and potential risks and concerns. Also check out our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Stakeholders from across the healthcare industry — from manufacturers and consultants to outside counsel and government officials — recently convened in Chicago for the Medicaid Drug Rebate Program Summit 2025. In this episode of Connected With Latham, Washington, D.C. partner Chris Schott, counsel Nicole Liffrig Molife, and associate Danny Machado share impressions and key takeaways from the conference, including action items like readying litigation support to address likely future challenges. Also check out our bi-weekly Drug Pricing Digest on the website or subscribe to receive future editions in your inbox.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200