This bill prohibits direct-to-consumer advertising of new drugs during the first three years following their approval by the Food and Drug Administration (FDA). Direct-to-consumer advertising includes advertising via social media.
Upon request from a drug’s sponsor, the FDA may waive the prohibition during the third year following a drug’s approval if it determines that the direct-to-consumer advertising of the drug would have an affirmative value to public health. Conversely, the FDA may prohibit such advertising beyond the three-year period following approval if it determines that the drug has significant adverse health effects based on post-approval studies, adverse event reports, and other appropriate resources.
The prohibition applies to new drugs approved beginning one year before the bill’s enactment.