At last! Some economic data on the impact of REMS, the FDA's risk evaluation and mitigation strategy program intended to ensure that drug benefits outweigh risks.
The study, by the Center for Healthcare Supply Chain Research and its partner of the Healthcare Distribution Management Association (HDMA), indicates unsurprisingly that REMS requirements are costly to the supply chain. But it demonstrates also that hidden, unforeseen and currently not reimbursable costs are taxing the drug distribution system.
For manufacturers, REMS costs are divided between setup and monthly maintenance, the authors say in Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, which is available for $185. Each line item ranges from a low of $5,000 to $250,000, to a high of $100,000 to $500,000. Development times range from 20 to 120 days, as reported in Pharmaceutical Commerce.
For distributors, the minimal for line items is $5,000 to $1,000,000, due to the range of data reporting that can be required.
The 57-plus-page report includes sections reviewing REMS tasks and associated costs for manufacturers, distributors and healthcare providers. Even simple REMS implementations, according to the report and as indicated in our offering, "Expert Tips for REMS Success," present supply chain issues that can be a time-consuming burden.