FDA requires REMS for certain drugs and biologic products.
The Food and Drugs Amendment Act of 2007 required that companies submitting an application for approval of a new drug or biologic product to the FDA also submit a risk evaluation and mitigation strategy (REMS) when the FDA decides that such a program is necessary to be certain that the benefits of a new drug or biologic product outweigh the risks. The FDA approves the elements of the REMS programs, and FDA has the authority to inspect and enforce that these elements are followed.
Medication Guides in a REMS Program
The FDA requires different elements in REMS programs. Medication guides are the most common strategy. These are used to notify patients of risks that may be severe enough that patients could use that information to decide to take the drug or not, when adherence to the drug is critical for effect or when labeling could prevent a risk. The FDA may require that medication guides be given out when the drug is first prescribed, with each administration and whenever the guide changes substantially.
Communication Plan in a REMS Program
Another common element in REMS programs is a requirement that the manufacturer of the drug develop a formal communication plan to all relevant health care providers. This may involve setting up a website, communicating with professional societies and sending letters to physicians, pharmacists, medical offices and hospitals.
Elements to Assure Safe Use in a REMS Program
The FDA may require certain elements to assure safe use of the drug in a REMS program. These are much more complex processes that can require prescribers to undergo special training, obtain certification and register to use the drug. Patients may need to sign an agreement with their provider when the drug is prescribed.
Drugs with REMS Programs
Currently, there are 181 drugs and biologics that have required REMS programs from the FDA. The list of these drugs and the specific requirements are available on the FDA website. The list is updated and changed frequently.
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