The FDA announced on Wednesday an initiative aimed at developing solutions to reduce injuries resulting from avoidable medication misuse and errors. As part of its efforts, the agency indicated that it may require some drugmakers to establish a formal risk-management plan to make physicians aware of product warnings and to help ensure that drugs are being used as intended.

The regulator explained that it will collaborate with healthcare professionals and other stakeholders "to identify drugs and drug classes that are linked to preventable harm." The FDA, which mentioned simplifying product labelling as another proposal to improve drug safety, noted that it will hold public meetings to gather comments and plans to start its first initiatives within the next 12 months.

Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, remarked that the initiative is "a paradigm shift" for the FDA. "We are going beyond our traditional role as regulator of the industry and reaching out to make sure we are impacting the real problems out there," she said.

Reference Articles

FDA unveils safe use initiative that targets preventable harm from medication use - (FDA)

Safe Use Initiative - (FDA)

US FDA aims to fight avoidable harm from medicines - (Forbes)

FDA launches plan to curb accidental overdoses - (The New York Times)

FDA aims to cut drug errors, issues liquid medicine guidelines (free preview) - (The Wall Street Journal)