REMS stands for Risk Evaluation and Mitigation Strategy. Developed by the US Food and Drug Administration (FDA), REMS is a strategy to manage a known or potential serious risk associated with a pharmaceutical or biological product. The FDA requires a REMS if they determine that one is necessary to ensure the benefits of the product outweigh the risks.
The FDA's increasing authority to enforce REMS has changed how pharmaceutical manufacturers conduct business, including how they effectively market their products. This, in turn, affects the training of pharmaceutical sales reps, who are required to know about REMS and how it affects what they do.
The logic behind REMS is that it should allow drugs with significant risks (usually side effect risks) to enter the market or stay on the market while post-marketing education, monitoring, and data collection are performed to keep these risks in check.
What A REMS Requirement Includes
There's no singular REMS protocol. Depending on the FDA's evaluation of a product, a REMS might include:
• A medication guide or patient package insert
• A communication plan to healthcare providers
• An ETASU, or Elements to Assure Safe Use, which may specify dispensing of a drug only in certified settings, or through a patient registry
• An implementation system based on an ETASU, which may include certification of prescribers, pharmacists, or distributors of products
These potential REMS elements have increasing complexity as you go down the list, with the medication guide being the simplest element and ETASU implementation systems being more complex.
When a REMS is required, drug companies have to execute it, and they have to survey patients or prescribers to confirm that the necessary REMS processes have taken place. Survey information is reported to the FDA starting 18 months after the FDA imposes a REMS requirement. Reporting can continue for up to seven years. So far, the FDA has approved REMS for around 200 individual products.
Why REMS Compliance Is Critical
When a REMS has been imposed, noncompliance can bring serious consequences, so everyone involved, from drug production through marketing via pharmaceutical sales reps has to understand the regulations. Not complying with REMS can bring about warning letters, fines, and even criminal charges. Corporate and personal liabilities from REMS noncompliance include:
• Civil monetary penalties of up to $250,000 per violation
• A declaration of drug misbranding
• Prohibition of introducing a drug into interstate commerce
• Criminal sanctions (misdemeanor or felony)
• Warning letters
• Ability of the FDA to withhold actions on other pending applications
• Exclusion of companies from participating in FDA-regulated activities
• Exclusion from federal healthcare programs
And of course, reputational damage and public relations problems can result as well.
REMS in Pharmaceutical Sales Training
When a REMS has been imposed by the FDA, it obviously affects pharmaceutical sales training. Pharmaceutical reps have to understand how any drug they market that is subject to REMS is affected, and what specific elements are required under any applicable REMS. When a REMS requires specific educational materials for prescribers and patients, pharmaceutical reps have to be adequately trained so they know which materials are required, what's in the materials, and how to effectively present them to prescribers and patients. In other words, REMS adds another layer of knowledge required of the sales rep when a REMS applies to the products he or she markets.
Pharmaceutical sales trainers have to thoroughly understand the FDA requirements for developing REMS programs that are compliant so that sales reps can do their jobs without running afoul of REMS requirements.
At CLD, we stay abreast of any and all REMS requirements to develop pharmaceutical sales training programs that ensure sales reps understand REMS and know what they have to do to market their products effectively while always remaining in compliance. To learn more about how CLD can help your sales team develop the knowledge and skills necessary for REMS compliance while effectively marketing your products, contact us online. We'll be happy to assist you.