Represented multiple drug establishments spanning global manufacturers, 503B outsourcing facilities and 503A compounding pharmacies in FDA inspections involving multiple Form 483 observations related to current Good Manufacturing Practice (cGMP) deviations, including development of the corrective and preventive action (CAPA) plan and preparation of the written response to the agency.
Counseled a national digital pharmacy in responding to a multi-state board of pharmacy investigation concerning allegations of improper controlled substance dispensing practices, coordinating simultaneous responses to disciplinary inquiries, negotiating consent agreements preserving the client's pharmacy licenses and implementing enterprise-wide compliance program enhancements to satisfy board-imposed remedial conditions.
Defended clients in FDA import detention proceedings, successfully challenging the agency's detention of multiple articles by demonstrating substantial compliance with applicable drug registration, labeling and cGMP requirements.
Represented a compounding pharmacy in a board of pharmacy enforcement action alleging violations of USP <795> nonsterile compounding standards and USP <797> sterile compounding standards, including preparation of the response to the board's notice of charges, representation at the formal administrative hearing and negotiation of a settlement agreement permitting continued operations subject to enhanced quality assurance protocols and periodic inspections.
Managed FDA drug recall activities for pharmaceutical manufacturers, distributors, compounding pharmacies and outsourcing facilities, including classification assessments, preparation and submission of recall notifications to FDA, development of customer and patient notification strategies, and drafting and filing associated state-level recall notices to boards of pharmacy and state health departments as required by applicable state law.
Advised a compounding pharmacy in connection with an unannounced FDA inspection and subsequent Warning Letter alleging adulteration and misbranding violations, including development of a comprehensive response strategy and negotiation of a close-out resulting in issuance of an Establishment Inspection Report (EIR) without further enforcement action.
Counseled a national pharmacy in responding to a board of pharmacy investigation concerning its central pharmacy operations, including allegations of inadequate pharmacist supervision, failure to maintain proper recordkeeping for controlled substances, and noncompliance with sterile compounding regulations, resulting in closure of the investigation without formal disciplinary action.
Advised a wholesale drug distributor in connection with a board of pharmacy investigation, including negotiation of a consent order that preserved the client's wholesale distribution license.
Negotiated with the Drug Enforcement Administration on behalf of a pharmacy facing potential revocation of its DEA registrations following an investigation into controlled substance recordkeeping deficiencies, securing terms that permitted continued dispensing operations subject to enhanced monitoring, periodic audits and implementation of a corrective action plan addressing identified violations of the Controlled Substances Act and DEA regulations.
Represented a drug establishment in negotiations with the U.S. Department of Justice and FDA concerning entry of a consent decree of permanent injunction, securing terms that permitted continued operations at the company's primary facility subject to retention of a third-party cGMP expert, completion of specified remediation milestones and FDA verification inspections, and subsequently counseled the client through multi-year compliance with the decree's requirements, including preparation for and successful completion of third-party audits and submission of periodic status reports to the FDA.
Represented pharmacies, outsourcing facilities, wholesale distributors and manufacturers in drafting and submitting required notices and applications to boards of pharmacy, DEA and other regulators due to change of ownership (CHOW), restructuring, change of location or change of name.
Provided federal and state legislative and regulatory advocacy on behalf of a national drug trade association, including drafting testimony for legislative hearings, preparing position papers on proposed legislation affecting the pharmaceutical supply chain, coordinating coalition advocacy efforts with allied industry stakeholders and engaging directly with legislators and state regulators to advance the association's policy priorities.
Developed and submitted formal comments to FDA on behalf of stakeholders in response to proposed rulemakings, draft guidance documents and requests for information on regulatory topics including drug compounding.
Drafted and filed science- and policy-driven citizen petitions with FDA on behalf of pharmaceutical and life sciences clients.
Advised digital pharmacy platforms and telehealth companies on federal and state regulatory compliance, including multi-state pharmacy licensure requirements, board of pharmacy rules governing the dispensing of prescription medications via mail order and delivery, DEA regulations applicable to the online prescribing and dispensing of controlled substances, FDA requirements for direct-to-consumer pharmaceutical advertising and promotion, telemedicine prescribing modalities, and development of compliance frameworks to support expansion into new state markets.
