Kevin M. Madagan Partner

Experience

Advertising, Promotion, and Labeling

• Served over 5 years as the primary legal advisor on promotional review committees for multiple product lines (oncology, dermatology, ophthalmology, psychiatry, other). This work included helping the client launch five product lines, many of which have very robust social media presence and patient-facing campaigns.*
• Provided healthcare compliance guidance for various therapeutic areas including Dermatology, Biologics, Neuroscience, Oncology and Ophthalmology.*
• Advised global pharmaceutical company executives on healthcare compliance policies procedures and laws.*
• Collaborated with Medical and Regulatory Affairs to conduct a detailed review and evaluation of the adequacy of promotional claims and tactics to ensure consistency with approved labeling.*
• Provided ad-hoc legal support to a global pharmaceutical supplier regarding OTC monograph and TFM compliance related to a new dosing technology.*
• Provided ad-hoc legal support to the consumer health care division of global pharmaceutical manufacturer, including periodically serving as legal representative on promotional and labeling review committees for over five OTC drug and device product lines with robust digital marketing campaigns.*
• Provided key, long-term, multi-year support to the legal departments of multiple global pharmaceutical manufacturers, including advertising/labeling on commercial marketing committees for over ten prescription drug product lines.*

Supply Chain Logistics and Compliance

• Advised global pharmaceutical company about viable distribution and FDA labelling and co-packaging options designed to support a single, combination pricing structure for the use of two products as a combination therapy.*
• Advised pharmaceutical company about co-packaging and therapeutic drug and device kitting options designed to support a dual distribution model involving infusion centers and specialty distributors.*
• Served as regulatory counsel to global carrier and 3PL distributor.*
• Served as specialized FDA counsel to multiple global pharmaceutical manufacturers to provide ad-hoc legal support regarding state and federal supply chain management, track/trace (pedigree) compliance, and DQSA/DSCSA implementation.*
• Represented multiple wholesale distributors, 3PLs, carriers, suppliers, and pharmacies, including national long-term care and nuclear pharmacy chains, as health care regulatory counsel on ongoing operational and compliance issues (e.g., track/trace, recalls, internal investigations, training, policy development).*
• Assisted multiple drug and device manufacturers, initial importers, contract manufacturers, and manufacturers of API in resolving detention and import/export issues.*
• Negotiated supply, distribution, and repackaging agreements for drugs and devices.*
• Provided strategic counseling and regulatory support to a national drug distributor during a Congressional investigation into drug shortages and supply chain security.*

Transactional Support

• Served as FDA regulatory counsel for $38 million IPO of pharmaceutical company focused on the development of therapeutics to treat kidney disease.*
• Served as FDA counsel to global distributor with its $800 million acquisition of a medical supply and equipment operation.*
• Served as FDA regulatory counsel on team representing a marketer and distributor of brand name OTC health care and household cleaning products in its $750 million acquisition of a pharmaceutical company, and in its simultaneous divestiture of certain product lines.*
• Served as FDA counsel to national nuclear pharmacy operation (and portfolio company of a client) on multiple acquisitions (ranging from $26 to $80 million) of PET radiopharmaceutical manufacturers, nuclear pharmacies, and outsourcing facilities in the United States.*
• Served as FDA counsel to client acquiring medical device software operation related to the radiopharmaceutical industry.*
• Served as FDA counsel for $220 million acquisition of privately-held global manufacturer specializing in coatings for industrial applications and consumer products, including medical devices.*
• Served as FDA regulatory counsel for $38 million IPO of pharmaceutical company focused on the development of therapeutics to treat kidney disease.*
• Served as FDA regulatory counsel for $10 million IPO of medical risk-assessment and device manufacturing company.*
• Served as FDA regulatory counsel to underwriter of $25 million IPO and subsequent $13 million follow-on offering for a clinical-stage company focused on developing its proprietary adjuvant technology for use in a number of oncology and infectious disease indications.*
• Served as FDA counsel to underwriter of $26 million IPO for a clinical stage medical diagnostics company.*
• Served as FDA counsel to follow-on underwritten public offering of $23 million for leading developer of novel therapeutic products that modulate the human gut microbiome.*
• Advised biosciences company in closing a joint-development and commercialization agreement involving pre-clinical Positron Emission Tomography (PET) X-Ray and 3-dimensional Computed Tomography (CT) imaging systems.*

FDA Regulatory Support

• Served as FDA counsel to clinical stage biopharmaceutical company.*
• Served as FDA counsel to clinical trial sponsor dealing with FDA inquiries and scientific misconduct uncovered at over a dozen clinical trial sites.*
• Advised clinical laboratories, including university and hospital system laboratories, regarding COVID-19 related testing and development, including helping to obtain and manage EUA applications and develop and manage LDT development and execution.*
• Advised clients about COVID-19 pandemic related matters, including helping device clients manage and obtain EUAs.*
• Served as FDA counsel to regional hospital system comprised of eight hospitals and roughly 2,400 physicians.*
• Provided counsel to an ex-US electronics company related to medical mobile apps and FDA regulation of medical device, including of mitigation of risk through compliant marketing claims and labelling.*
• Advise medical device companies about software as a medical device (SaMD) and software in a medical device (SiMD) matters and interpretation of the 21st Century Cure’s Act.*
• Advised a global medical device manufacturer about FDA authority and response strategies while FDA investigators were on site.*
• Assisted manufacturers of pharmaceutical drugs, biologics, and medical devices in drafting petitions to FDA (e.g., Citizen Petitions, 513(g) Requests, Requests for Reconsideration), coordinating responses to FDA enforcement actions (e.g., inspections, recalls, 483s, FDA untitled/warning letters, FDA Regulatory Meetings), and drafting trade complaints regarding false and misleading advertising/labeling.*
• Served as FDA counsel to a national positron emission tomography (PET) radiopharmaceutical manufacturer and nuclear pharmacy and outsourcing facility chain (a portfolio company of a private equity client).*
• Served as FDA counsel to global biotechnology company specializing in fungal based solid-substrate fermentation technology.*
• Served as FDA regulatory counsel to global active pharmaceutical ingredients (API), excipient, and chemical manufacturer and global distributor.*
• Assisted a global medical device manufacturer in obtaining a variance from FDA’s Medical Device Reporting (MDR) requirements.*

* The above matters were handled by Mr. Madagan prior to joining McGuireWoods LLP.