Overview
Alicia Whittlesey is a Principal of Porzio, Bromberg & Newman's New England office. With over 15 years of experience working as in-house legal and compliance for multiple companies including Biogen and Sunovion in the life sciences industry where she often “sat at the table” with business, Ms. Whittlesey leverages her background and experience by providing a valued business perspective guiding teams, management, and stakeholders and offering solutions that take into account business needs while helping to move a company forward in a compliant manner. Ms. Whittlesey has experience analyzing, advising, and managing legal, compliance, and commercial risks from a US perspective for pharmaceutical, medical device, and biotech companies.
She advises on legal, regulatory, and compliance matters governing the life sciences industry. These areas include marketing, advertising and promotion including the review of marketing, medical and corporate communications, clinical research, patient recruitment, social media, field sales activities, policy development/review and training, compliance assessments, internal/external communications, and interactions, patient advocacy, patient assistance and support programs. Ms. Whittlesey provides guidance related to fraud and abuse laws, Anti-Kickback, PhRMA Code and other industry guidelines, Food, Drug & Cosmetics Act, and FDA guidance and regulations.
News
Articles
- Are There Different Rules if a Company Uses Celebrities or Another Third-Party Endorsement? , 10/18/2024
- Social Media: Good, Bad or Something In-Between?, 3/13/2024
- Something Old, Something New: Hot Topics and Enforcement Trends of 2023, 12/27/2023
- Navigating the New FDA Draft Guidance: Evolving Manufacturer Considerations When Providing Scientific Information for Unapproved Uses, 11/03/2023
- Should Compliance have an "on-line" or "off-line" role?, 12/16/2020
- Communication During a Pandemic, 4/27/2020
- Regulatory and Legal Roles in Promotional Review Committee Meetings: Is There Really a Difference?, 2/27/2020
Events
Speaking Engagements
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"How to Harness the Transformative Power of MLR in Promotional Review," Food & Drug Law Institute, Advertising & Promotion for Medical Products Conference, 10/18/2024
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"Updated FDA Enforcement Trends and Increased in Ad/Promo Related Warning Letters," 5th Annual Life Science Advertising & Promotion Regulatory Affairs Conference, https://www.q1productions.com/life-science-advertising-promotion/agenda/
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"The Intersection of Legal and Compliance – Understanding the Risks of the Federal Anti-Kickback Statute for HCP Engagements & Transparency," 2022 Transparency, Aggregate Spend & HCP Engagement Conference, 8/10/2022
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"Closing Remarks," Porzio's Ethics & Eggs 2021, 12/09/2021
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"Enforcement Action Current Trends: Compliance Takeaways from the Incyte Complaint," Porzio Life Sciences Webinar, 6/30/2021
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"Compliant Patient Interactions," CBI's 16th Annual Pharmaceutical Compliance Congress, 4/18/2019
Prior Relevant Experience
- Biogen, Weston, MA, Commercial Counsel Legal Affairs, 2013-2018
- Sunovion Pharmaceuticals Inc. (formerly sepracor Inc.), Marlborough, MA, Counsel, 2008-2010; Senior Counsel, Commercial Legal Affairs, 2010-2012
- Bristol-Myers Squibb Company, Plainsboro, NJ, Associate Counsel, 2005-2008
- Eisai Inc, Teaneck, NJ, Administrative Assistant, Paralegal, 1996-2002; Counsel, 2002-2005