Jonathan A. Keller, PharmD

Regulatory Experience

As the co-chair of the pharmacy and pharmacy benefit manager (PBM) group within the health and life sciences industry team, Jonathan regularly counsels pharmacies, wholesalers, 3PLs, drug manufacturers, hospitals, provider groups and telehealth platforms on numerous aspects of their pharmacy-related businesses. Much of Jonathan’s work in this regard focuses on:

• State and federal licensing
• LegitScript Healthcare Merchant Accreditation and NABP Healthcare Merchant Certification
• Board of Pharmacy inquiries and investigations
• Drug compounding (503A and 503B facilities)
• Drug marketing, advertising and promotion
• Controlled substance, drug diversion and DEA enforcement
• 340B drug program compliance
• Telemedicine and telepharmacy
• Regulatory due diligence and change of ownership counseling in connection with the sale, acquisition and restructuring of FDA and board of pharmacy regulated entities
• Drug distribution and supply chain laws and regulations, including the federal Drug Supply Chain Security Act
• Medicare and Medicaid provider enrollment

Transaction Experience

As part of his transactional experience, Jonathan often works with community, mail-order, specialty and non-dispensing pharmacies, PBMs, drug manufacturers, wholesalers, physician groups and other health care providers and suppliers in a variety of contexts, including mergers and acquisitions, joint ventures, hospital and physician affiliations, establishing captive PCs and management organizations, and drafting clinical trial agreements. Jonathan also advises health care clients and captive physician groups on corporate practice-of-medicine laws and associated regulations.

In-House Counsel Experience

Prior to entering private practice, Jonathan served as the general counsel at East Orange General Hospital and was a member of the hospital’s executive team. During his tenure at the hospital, Jonathan was heavily involved in the hospital’s acquisition by a for-profit, private equity-backed entity and was responsible for the day-to-day legal operations at the hospital. This included preparing physician employment agreements, advising the hospital’s medical executive committee on credentialing and medical staff bylaw matters, overseeing the compliance and risk department, negotiating large vendor agreements and managing the insurance policies for the hospital. Jonathan also served as secretary to the hospital’s board of trustees of the hospital.

Jonathan leverages his in-house operational experience to provide practical, business-minded solutions to often nuanced issues for health care and life science companies.

Representative Experience

Pharmacy

Results may vary depending on your particular facts and legal circumstances.

• Representation of Elevance Health f/k/a Anthem, Inc. on a variety of pharmacy licensing, Medicare/Medicaid enrollment and compliance program matters in connection with strategic transactions
• Representation of several Fortune 10 companies on day-to-day pharmacy licensing and regulatory matters, as well as in connection with strategic transactions
• Representation of drug manufacturers in connection with federal and state compounding laws and FDA guidance
• Representation of large infusion care pharmacies regarding innovative drug delivery models
• Representation of a 50-state licensed reverse drug distributor in connection with licensure, compliance, controlled substance, and drug supply chain matters
• Representation of numerous digital health platforms and telehealth providers in connection with LegitScript Healthcare Merchant Certification and NABP Healthcare Merchant Accreditation compliance
• Representation of numerous online pharmacies in connection with board of pharmacy investigations and inquiries
• Representation of a 50-state licensed 503A compounding pharmacy in connection with a California Board of Pharmacy investigation and complaint
• Representation of a 503B outsourcing facility in connection with an FDA inspection, issuance of a Form 483, and development of a corrective action plan
• Representation of several non-dispensing pharmacies in connection with board of pharmacy licensure matters
• Representation of a 50-state licensed mail-order pharmacy regarding telehealth prescribing requirements, patient-provider relationship establishment, and use of online questionnaires
• Representation of a virtual manufacturer in connection with its 50-state licensure renewal process

Health Care

Results may vary depending on your particular facts and legal circumstances.

• Representation of the largest radiology physician practice group in New Jersey in connection with a joint venture with a leading academic medical center to establish a new outpatient radiology facility
• Representation of a surgical practice in New Jersey in connection with a change-of-ownership
• Representation of a large multispecialty medical clinic in Illinois in connection with the negotiating and drafting of clinical trial agreements with pharmaceutical company sponsors
• Representation of the owner and operator in connection with the sale of approximately 10 outpatient dialysis facilities across several states to a large, publicly traded owner of dialysis centers.
• Representation of an international testing, inspection and certification services company in connection with its acquisition of several U.S. based analytical laboratories and testing facilities
• Representation of a leading consumer packaged goods company in connection with its acquisition of a drug manufacturer of synthetic CBD and THC products
• Representation of a middle-market private equity firm in connection with its acquisition of multiple home health and nurse registry companies located in Florida
• Representation of nationally recognized nonprofit managed care organization in its acquisition of a leading provider of services for individuals with intellectual/developmental disabilities and behavioral health challenges.

Personal Interests

In his free time, Jonathan enjoys going with his family to the Jersey shore and exploring new hiking trails in northern Jersey. Jonathan is an avid car enthusiast and enjoys taking his cars for a drive, especially in the summer.