Managing Attorney and Principal
Jamie is considered by her peers to be a life sciences legal and regulatory compliance expert as she advises companies on a variety of U.S. Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues. She also provides a broad range of business advice and strategic counseling to pharmaceutical, device and biologic manufacturers. Clients turn to Jamie for guidance in connection with audits, government investigations, internal investigations, contractual arrangements and the development, implementation and review of compliance and ethics programs. Notably, corporate executives and boards of directors also seek Jamie’s counsel on matters related to developing, implementing, evaluating, and auditing internal compliance and ethics programs. As part of her regulatory practice, Jamie advises on marketing authorization issues to post-marketing compliance, lifecycle management and significant enforcement matters. She also advises clients on product recalls, marketing applications, labeling, marketing and advertising permissibility, and privacy issues. Jamie also works with clients on post-marketing obligations such as adverse event reporting and Approved Risk Evaluation and Mitigation Strategies (REMS).
- Representation of a major pharmaceutical company in federal and state government investigations involving the marketing and pricing of products.
- Representation of a life sciences client in a multimillion dollar commercial dispute involving material breaches of complex stock purchase agreement, licensing and distribution agreements.
- Counseling clinical-stage biotech companies on wide-variety of business/legal strategies and issues.
- Representation of an international life sciences client in a matter involving unfair sales practices by competitors.
- Representation of a major international pharmaceutical company in federal and state government investigations involving sales and marketing practices.
- Representation of a pharmaceutical company in internal investigation of its business practices and compliance.
- Day-to-day pharmaceutical and medical device company counseling on product marketing and promotion materials, including use of social media.
- Representation of pharmaceutical company in internal investigation of its contracting protocols and procedures in its selection and use of investigators in clinical studies and scientific meetings.
- Representation of life sciences client in internal investigations related to alleged kick-backs, off-label promotion, and reimbursement guidance.
- Representation of a life sciences client in Veterans Affairs Office of Inspector General (OIG) audit.
- Representation of a life sciences client in a pharmaceutical state licensing disciplinary action.
- Representation of a medical device company in internal investigation of its promotional business practices including surgical healthcare provider interactions.
- Jamie Kendall, Brad Welsh & Alexandra Schulz, Trump’s Push for Direct Medicare Drug Price Negotiations Addresses Only One Piece of the Industry’s Drug Pricing Puzzle, United States Biopharmaceuticals 2017, Global Business Reports, May 2017, at 25, available at http://gbreports.com/wp-content/uploads/2017/05/US-Pharma-2017-Web-Preview.pdf.
- Jamie Kendall & Alexandra Schulz, Why Patient Experience Data Provisions Face Elimination, Law360, (Mar. 22, 2017), https://www.law360.com/articles/904561/why-patient-experience-data-provisions-face-elimination.
- Jamie Kendall & Alexandra Schulz, What First Amendment? FDA Remains Unfazed By Off-Label Communication Issues, Pharm Exec.Com (Mar. 7, 2017), http://www.pharmexec.com/what-first-amendment-fda-remains-unfazed-label-communication-issues.
- Jamie Kendall & Noah Mallon, Does the FDA’s Draft Guidance on Responding to Unsolicited Off-Label Requests Align with the FDA’s Mission to Promote the Public Health?, The Food and Drug Law Institute Policy Forum, (Mar. 14, 2012), https://www.fdli.org/resources/policy-forum/ (Peer and FDA Reviewed).
- Jamie Kendall, From MSL to CSL (?): The Evolving Role of the Medical Science Liaison, Health Care Compliance Association, Compliance Today, Mar. 2012.
- Jamie Kendall, Corporate Integrity Agreements: A Look Back to the Future of OIG Investigations, Health Care Compliance Association, Compliance Today, Dec. 2011, at 38.
- Jamie Kendall, The Value is in the Juice Not the Squeeze: Why Reprints Should Not be TOVs Under the Sunshine Act, (Published as Sunshine sheds little light on status of reprints), Medical Marketing & Media, Dec. 2011.
- Jamie Kendall, Create a Scientific Publications Guidance Document to Ensure Continued Awareness and Compliance with Industry Best Practices, Regulations, Guidances and Laws, Presented at The International Society for Medical Publication Professionals (ISMPP), April 2011 Annual Meeting.
- “Lessons Learned: Compliance and Reporting Risks Identified as a Result of Preparing State Reports,” CBI’s 4th Annual Forum on Tracking State Laws and Aggregate Spend, August 2010.
- “Corporate Integrity Agreements Serve As Intelligible “Tea Leaves” as The Government’s Focus on Commercial-Related Activities Continues to Lead to Medical Affairs Activity Scrutiny,” FX Conferences, September 2011 and CIS, October 2011.
- “Government Enforcement on Medical Affairs and Commercial-Related Activities,” CIS, October 2011.
- “Social Media: Changing the Way the Industry Interacts one Click at a Time,” CIS, October 2011.
- “The UK Bribery Act is Upping the Ante on Anti-Corruption and Anti-Bribery Enforcement,” FX Conferences, February 9, 2012.
Jamie’s prior legal experience includes serving as General Counsel for a U.S. pharmaceutical company that has international touch points. She was also an associate with Morgan Lewis & Bockius LLP in its Philadelphia Litigation Practice Group. While there, she represented pharmaceutical and medical device companies in complex civil litigation and government investigations involving products liability claims, state and federal false claims statutes, the Stark Law, fraud and abuse violations and state and federal anti-kickback statutes.
Jamie earned her Juris Doctorate from Rutgers University School of Law – Camden. While at Rutgers Law School, she worked as a judicial law clerk for the Honorable William C. Carpenter, Jr. of the Superior Court of Delaware, the Honorable F.J. Orlando, Jr. A.J.S.C. of the Superior Court of New Jersey, and the Honorable M. Faith Angell of the U.S. District Court for the Eastern District of Pennsylvania. Jamie earned her B.A. in Journalism from Indiana University of Pennsylvania and is admitted to practice in the state and federal court of both Pennsylvania and New Jersey. Jamie currently serves as general counsel to the PDE – the longest running Pharmaceutical Trade Association.