FDA discusses REMS during webinar
All medicines approved by the FDA go through assessments to determine their benefits and risks. In some instances, the FDA requires that manufacturers put an REMS into place to ensure that drugs and biologics are used safely.
An REMS may be part of a new product's approval process or it may be used for an already approved product after the agency learns of new safety information.
"Essentially, a REMS is a safety strategy to manage a known or potential serious risk of a medicine and to enable patients to have continued access to these medicines by managing their safe use," Theresa Toigo, the associate director for drug safety operations at the FDA, said.
Strategies used for an REMS include specific steps a physician must take, such as special training programs, prior to being allowed to prescribe a medication. A pharmacy may have to meet certain certification requirements before being allowed to dispense a drug.
Toigo said that most REMS programs involve extra patient education about benefits and risks of medications and information about how to use the product safely.
The webinar was part of an online series hosted by different FDA offices as part of FDA Basics, an online-based resource meant to help the public better understand what the agency does to protect the health of the nation.