Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result, the potential access to medications that are effective but not without safety concerns has improved, yet the converse is also true because access may be restricted due to REMS requirements (eg, physician or patient registration).
Approximately 40% of all newly approved drugs are subject to safety restrictions inclusive of Risk Evaluation and Mitigation Strategies (REMS), which were created with the US Food and Drug Administration Amendments Act of 2007. This law expanded Food and Drug Administration (FDA) authority to require REMS of manufacturers but left implementation to the FDA. As a result, the potential access to medications that are effective but not without safety concerns has improved, yet the converse is also true because access may be restricted due to REMS requirements (eg, physician or patient registration).