The 2007 amendments to the Food and Drug Law authorized the FDA to require submission of risk evaluation and mitigation plans (REMS) in connection of approval of a new drug or if new safety information arises regarding a marketed drug. The FDA has issued a draft guidance relating to these risk plans. (FDA Guidance) Over the last decade or more the FDA has suffered a series of safety embarrassments relating to approved drugs, in many cases necessitating removal of the drug from the market. This is the latest iteration of attempts to enhance safety monitoring.
REMS are basically an evolution of the RiskMAPs that the agency issued a guidance on in 2005. The intent is to require that when a drug has a potential safety issue, patients and prescribers are aware of the issue and the drug company is collecting and analyzing information to identify the extent that adverse events are actually occurring. Some have expressed concern that the FDA may become even slower in approving new drug applications, given the recent safety problems. The ability to use REMS may ameliorate excess caution on the part of the FDA or coming to agreement with the agency on a REMS may itself slow up the approval process.
Consumers and prescribers need to have confidence in the safety of drugs. REMS plans may help with that. This additional safety infrastructure will certainly provide opportunities for vendors to sell more clinical trial and data study services to drug and biotech companies.