FDA Plans To Finalize DTC Ad Risk Statement Requirements In Mid-2019

FDA plans to finalize in mid-2019 its nearly decade-old proposed rule mandating that direct-to-consumer prescription drug advertisements state the drug’s major side effects and risks in a “clear, conspicuous, and neutral manner,” according to the agency’s fall 2018 regulatory agenda released Tuesday (Oct. 16). The agency also will implement standards to help determine whether the major statement in these advertisements is presented in the manner required, the unified agenda says. FDA first shared details of the proposed rule in the...