This website uses cookies

This website uses cookies to ensure you get the best experience. By using our website, you agree to our Privacy Policy

International In-house Counsel Journal logoInternational In-house Counsel Journal logo
Back to library search

The Impact of the Fraud and Abuse Laws on Pharmaceutical Advertising and Marketing Compliance: A Manufacturer's Perspective

Abstract

The intersection between the health care fraud and abuse laws and pharmaceutical marketing practices in the U.S. raises interesting compliance issues for pharmaceutical manufacturers, particularly in light of the newly enacted federal health care reform legislation.  The legislation includes significant anti-fraud measures as well as additional funding to fight fraud and abuse.  Such increased scrutiny on pharmaceutical promotional practices requires manufacturers to pay close attention to and comply with the heath care laws, regulations and guidelines.  Compliance is the only clear path to minimizing exposure to potential liability.

Author

Leslie Restaino
General Counsel, Validus Pharmaceuticals, USA

Leslie Gladstone Restaino, Esq. is an experienced life sciences attorney and compliance professional with diverse background in all aspects of drug and medical device development, approval, commercialization, compliance, intellectual property and commercial transactions. She currently serves as General Counsel to Validus Pharmaceuticals LLC, a specialty pharmaceutical company

Company

Validus Pharmaceuticals

Validus Pharmaceuticals is a wholly owned subsidiary of Konanda Pharma Partners, a newly created private equity fund focused on acquiring specialty pharma branded products. Validus is focused on acquiring, reformulating and marketing prescription products relevant to the psychiatry and neurology markets. Validus seeks to acquire mature products that have well defined and accepted clinical utility relevant to today’s practice of medicine. Validus’ portfolio currently includes Marplan®, which is indicated for the treatment of depression. Marplan is a member of the monoamine oxidase inhibitor class of antidepressants.

Related Papers

A Path Through the Forest - The Role of Agency Guidance in Developing Regulatory Compliance Programs
Counsel involved in developing regulatory compliance programs know that merely looking at the statute and regulations is not enough. They need to look to multiple sources of information to determine...Read more
Portrait image of Jack Sorokin
Jack Sorokin
Adjunct Instructor, Fremont College, USA
The EU Regulation on Digital Operational Resilience for the Financial Sector: Applicability & Compliance Guidance for ICT Service Providers
The European Union (‘EU’) Regulation on Digital Operational Resilience for the Financial Sector EU 2022/2554 (‘DORA’), the new cybersecurity framework for the entire financial sector of EU along with...Read more
Portrait image of Subhrarag Mukherjee
Subhrarag Mukherjee
Senior Legal Counsel – Strategic Alliances & OEM (North America & Worldwide), Hewlett Packard Enterprise, India
UK Economic Crime and Corporate Transparency Act 2023 - Failure to prevent fraud: Storm in a tea cup?
The Failure to Prevent Fraud offence contained within the UK Economic Crime and Corporate Transparency Act 2023 (ECCTA) finally comes into effect on 1 September 2025 following the release of...Read more
Portrait image of Steve Holt
Steve Holt
Partner, Grant Thornton UK, UK
Portrait image of Oishi Ghosh
Oishi Ghosh
Forensic Investigation Services Manager, Grant Thornton UK, UK
Portrait image of Ollie Haselden
Ollie Haselden
Assistant Manager within the Forensics and Investigations department, Grant Thornton UK, UK
The Importance of Compliance Programs
The interest in the proposed topic arose from the need to discuss the social and economic changes brought about by the concept of compliance and the Brazilian Anti-Corruption Law. We...Read more
Portrait image of Cristina Leite
Cristina Leite
Procurement Risk & Compliance Senior Consultant, ., Brazil
Portrait image of Thaíssa Felguerias
Thaíssa Felguerias
Senior Compliance Specialist, Hydro, Brazil