2017 marks the tenth anniversary of the legislation that created the safety protections called Risk Evaluation and Mitigation Strategies (REMS). Yet, recognition of the need to mitigate the risks of prescription drugs dates back almost 50 years.
Initial Drug Safety Efforts: 1970s-1990s
Long before REMS, the Food and Drug Administration (FDA) endorsed the requirement in the late 1970s to distribute Patient Package Inserts (PPIs) with oral contraceptives and estrogen replacements so patients would have written information about the benefits and risks of these drugs. Then, starting in the late 1980s, FDA recognized the need to restrict access to certain potentially dangerous medicines and in the late 1990s, the agency began to require pharmacists to distribute medication guides to patients when there were potentially serious health concerns.
Setting the Stage for REMS
By the early 2000s, a series of high-profile drug withdrawals caused FDA to develop a systems approach to risk management called Risk Minimization Action Plans (RiskMAPs), which laid out specific actions to mitigate the ensure the safe prescribing and use of medicines known to cause adverse effects. However, the widely publicized withdrawal of the pain killer Vioxx in 2004 exposed some fundamental weaknesses with RiskMAPs, setting the stage for Congress to authorize the REMS program in 2007.
Below are the milestone moments leading up to the introduction of the REMS program and the evolution of this program today.