Selected Achievements
Regulatory
Developed a cheap, efficient regulatory strategy which rescued development of a several-hundred million dollar product which had been abandoned due to regulatory requirements.
Educated and trained pharma executives in media appearances; trained pharma marketing and sales personnel in FDA advertising and promotional requirements and compliance.
Filed one of the first petitions for Waxman-Hatch three-year exclusivity.
Developed regulatory strategies for drugs, medical devices, cosmetics, drafted device applications to the FDA, negotiated labeling and received FDA approvals.
Regulatory/Criminal
Successfully prevented indictment of several executives of several pharmaceutical companies in grand jury investigations.
Successfully shepherded companies through DEA inspections and enforcement actions and preempted criminal enforcement action.
Successfully defended companies from State Boards of Pharmacy disciplinary actions.
Assisted generic companies in the Application Integrity Policy, developed corrective action plans, negotiated status with the FDA, enabled them to emerge continue operation. Responses to OAI and Warning Letters, crafted corrective advertising and other remediation.
Litigation
Achieved a favorable verdict and substantial award in a jury trial in Federal Court in a whistleblower case against a major pharmaceutical company involving the Director of Quality Assurance.
Defeated a trademark claim by a major multi-national pharmaceutical company against a generic client’s advertising and promotion.
Prevented FDA from shutting down a pharmaceautical company for alleged cGMP violations, thereby permitting their continued operation while undertaking corrective actions.
Commercial
Placed a product developed by a generic pharmaceutical company with a brand-name company and negotiated a lucrative, multi-year product license for the client with a substantial up-front payment and royalty stream.
Placed an innovative generic product with a multi-national pharmaceutical company for marketing abroad. This led to the acquisition of the innovative technology and its implementation in a broad range of innovative drug products.
Administrative
Achieved a favorable verdict and substantial award in a jury trial in Federal Court in a whistleblower case against a major pharmaceutical company involving the Director of Quality Assurance.
Arbitration
Obtained several favorable verdicts in arbitrations before the American Arbitration Association involving performance of clinical trials; enforcement of executive’s employment agreement severance.
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