Why Does it Matter?

Why do REMS matter?

REMS perform a unique and necessary function: to provide an avenue for the Food and Drug Administration (FDA) to approve certain drugs and biologicals that would otherwise not be on the market.  As a result, millions of Americans with serious diseases and rare disorders are now being treated effectively with medications that carry REMS requirements.

Prior to 2007 – the year Congress passed the law that established REMS – the nation had witnessed several situations where widely used drugs were taken off the market. This left many patients with limited alternatives and in some cases, no recourse at all. Thus, Congress acted to give FDA the authority to require REMS, resulting in added protections for the public and the pathway needed for FDA to allow patient access to valuable medicines with known safety risks.

Yet, even as REMS have become an integral part of FDA’s arsenal to mitigate the potential risks of valuable medicines, protecting patient safety is sometimes viewed as being in conflict with policies to accelerate generic drug development. However, these two goals are not in conflict. This is because very few medicines require REMS restrictions and FDA procedures are in place to ensure that generic versions of REMS drugs are approved with the same REMS requirements as the branded products.

How do we know the REMS program is working?

FDA works with the manufacturer to develop an assessment plan to evaluate each REMS.  Assessment plans describe the information that sponsors must collect to determine whether the program is meeting its goals and that the benefits of the drug medicine outweigh the risks.  For example, FDA may request that a manufacturer’s assessment include reporting on the number of patients enrolled in a registry or an evaluation of patients’ understanding of a drug’s risks. After the assessment plan is finalized and put in place, the FDA continues to review reports filed by the manufacturer about the REMS’ effectiveness.

How many drugs require REMS programs?

REMS programs are limited to medicines whose life-saving benefits come with high risks; therefore, very few medicines on the market today require a REMS.

Underscoring this point, as of August 2019, only 61 individual medicines and drug classes require REMS restrictions out of the thousands currently marketed in the U.S. Of these, there are 51 REMS with “Elements to Assure Safe Use” (ETASU) for individual drugs. ETASU is the most restrictive type of REMS required by the FDA.

In addition, 13 of the 51 REMS with ETASU are shared systems, which allow products from multiple manufacturers, including generic manufacturers, to be distributed using the same safety protocols.

To see the complete list of the medicines that are subject to REMS, click here: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm