Joy represents large pharmaceutical, biotechnology, and medical device companies on a broad range of FDA regulatory issues. She counsels clients on promotional compliance matters, Hatch-Waxman exclusivity strategies, and government investigations, among other issues. Joy also provides FDA regulatory due diligence support for corporate transactional matters (e.g., licensing deals and M&A) and for securities filings for publicly traded life sciences companies.
Joy has significant experience with the advertising and promotion of pharmaceuticals and medical devices. While on a 7-month secondment to a major pharmaceutical company, Joy served as the sole product attorney for a $3 billion product, sitting on the promotional review committee and also advising the client on issues arising under the Anti-Kickback Statute and the False Claims Act. She has also served as the legal representative on review committees of emerging companies with single products.
Promotional Compliance
- Led a comprehensive review of the front- and back-end systems and controls relating to the promotional review committee process for one of the world’s largest research based pharmaceutical companies.
- Conducted a promotional compliance assessment for a major medical device company to identify high risk products and provided recommendations for mitigating identified risks.
- Assisted pharmaceutical manufacturers in responding to FDA Warning Letters alleging false or misleading promotion.
- Drafted a manual of promotional review standards for use by review committee members across a leading biotechnology company.
- Prepared a dietary supplement company’s response to an NAD inquiry concerning its promotional claims.
- Conducted an in-depth review of telesampling and video-detailing systems and controls for a major pharmaceutical company.
Hatch-Waxman and Life-Cycle Management
- Drafted a citizen petition for a leading pharmaceutical company concerning approval requirements for generic versions of discontinued antibiotic formulations, to which FDA took over three years to respond.
- During the course of complex ANDA patent litigation, counseled a major pharmaceutical company on Orange Book listings, section viii statements, and 180-day generic exclusivity issues.
- Drafted and filed citizen petition in 2009 for a global pharmaceutical company concerning labeling and bioequivalence requirements for generic versions of inhaler products, which petition remains outstanding at FDA.
Government Investigations
- Developed defenses for a medical device company executive who was a potential target in a government’s investigation of the company; no charges were brought against the executive.
- Advised companies and company executives under government investigation regarding OIG exclusion risk.
- Worked closely with Ropes & Gray litigators on numerous government investigations of pharmaceutical and device companies.
General Regulatory
- Assisted a leading biotechnology company throughout the biosimilars legislative process, commenting on legislation, drafting new legislative proposals, and preparing talking points for use in Congress.
- Conducted an internal investigation of a pharmaceutical company’s development program for its lead compound to evaluate an employee’s allegations that the company ignored safety signals from primate studies, mischaracterized human adverse events and delayed reporting others, and compromised patient safety by continuing trials in light of the data.
- Assisted a pharmaceutical company in responding to an FDA notice requiring discontinuation of the sale of certain “old” unapproved drug products and preparing for a meeting with FDA on the same.
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Education
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JD, Columbia University School of Law, 2002
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AB, Harvard College, 1999
Bar Admissions
- District of Columbia, 2007
- Massachusetts, 2002
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