McKesson Specialty Health is managing some of the industry's most complex and rigorous REMS programs mandated by the FDA. Our experienced team of clinical, safety, product launch, and data management experts are actively providing assistance to manufacturers through their REMS development process. We currently manage risk management programs across a spectrum of therapeutic areas, including oncology, opioids, rheumatology, neurology, pain management, and cardiovascular, among others.

Our deep expertise and broad range of capabilities enables us to provide customers with a unique, end-to-end REMS solution that meets FDA safety requirements for current programs while ensuring appropriate access to drugs and biologics. McKesson has the broad assets to design, implement, and manage all components of REMS, as demonstrated in our wide spectrum of capabilities.

Features

  • Consultation on FDA submissions, strategic program designs, and other consulting services
  • End-to-end program implementation
  • Validated registry with patient, physician, hospital, and pharmacy enrollment capabilities
  • Largest single-site call center in healthcare
  • Risk monitoring and clinical data collection by highly trained nurses
  • Assessment of program effectiveness through patient and provider surveys
  • Strong data management and safety reporting capabilities
  • Unparalleled program management and support team
  • Integration with reimbursement support services
  • Full range of distribution models
  • Ability to integrate with retail pharmacy solution
  • Rigorous program compliance monitoring and auditing
  • Clinical and regulatory expertise

Benefits

  • Reduce likelihood of drug launch delays by planning early and leveraging McKesson's experience in designing REMS and working with the manufacturer to obtain FDA approval of the REMS program
  • Increase program efficiency by working with a partner that can meet all of a manufacturers' REMS needs from program design, to implementation, to reporting, to distribution
  • Opportunity to ease the burden on physician offices by integrating manufacturers' REMS and reimbursement/access programs and creating a "one-stop-shop" for their customers
  • Ensure adverse events are captured and tracked appropriately per manufacturer's defined process in McKesson's validated environment
  • What is REMS?

    REMS is defined by the FDA as a program to manage a known or potential serious risk associated with a drug or biologic product. A REMS program may include:

    •  Medication guide 
    •  Communication plan 
    •  Elements to assure safe use 
    •  Implementation system 
    •  Restricted distribution 
    •  Timetable for assessment 

  • Contact Us

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    888-646-8776

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