Recommendations are Intended to Improve the Communication of Important New or Updated Safety Information for Prescription Drugs and Biological Products -

On January 23, 2014, the Food and Drug Administration (FDA) announced in the Federal Register that it issued a final Guidance for Industry and FDA Staff entitled, “Dear Health Care Provider Letters: Improving Communication of Important Safety Information.” The guidance provides specific recommendations on the content and format of DHCP letters that are sent by manufacturers or distributors to physicians and other Health Care Providers (HCPs) to communicate important new or updated safety information about (1) an important drug warning, (2) a change in prescribing information, or (3) a correction of misinformation in promotional labeling or advertising for a prescription drug or biologic product. The guidance also provides instructions regarding what should not be included in DHCP communications. In addition, the agency advises that manufacturers or distributors should conduct, for the company’s use, an assessment of the letter’s impact on communicating new information to HCPs.