User:Oceanflynn/sandbox/Risk Evaluation and Mitigation Strategy (United States)

Risk Evaluation and Mitigation Strategy (REMS) is a requirement by law for manufacturers to "ensure that the benefits of a drug or biological product outweigh its risks" under the provisions of 2007 amendment giving the U.S. Food and Drug Administration (FDA) "many new authorities and responsibilities to enhance drug safety."

Specialty drugs
On September 16, 2014 Genentech reclassified bevacizumab as specialty drugs which are only available through specialty pharmacies. "Specialty drugs usually fall under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, established for compounds like the testosterone... that may have unusual side effects; or for drugs that are unusually expensive." This has caused concern to hospitals as the price increased. According to IMS Health, the average price charged by hospitals for bevacizumab is approximately $9000 compared to approximately $2300 when administered in a doctor's office. As a result of the new distribution arrangement, many hospitals will no longer be eligible for the 51% discount to average wholesale price that was mandated by the Affordable Healthcare Act under the old distribution arrangement.

"Misuse of FDA REMS patient safety programs is one way that certain brand drug companies delay generic competition."