SUBJECT: Addressing Misleading Direct-To-Consumer Prescription Drug Advertisements In 1962, the Congress vested the Food and Drug Administration (FDA) with the authority to regulate prescription drug advertising.
Over time, however, the FDA’s requirements have permitted drug companies to include less information, particularly in broadcast advertising, and drug manufacturer advertising has skyrocketed in recent decades.
My Administration will ensure that the current regulatory framework for drug advertising results in fair, balanced, and complete information for American consumers.
The Secretary of Health and Human Services shall therefore take appropriate action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements, to the extent permitted by applicable law.
The Commissioner of Food and Drugs shall take appropriate action to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions, and otherwise ensure truthful and non-misleading information in direct-to-consumer prescription drug advertisements.
Tackling Deceptive Direct-To-Consumer Marketing.
advertisements for prescription drugs.
In 1962, the Food and Drug Administration (FDA) was given the power to control advertising for prescription drugs by Congress. These commercials have the potential to mislead the public about the advantages and disadvantages of medications, promote prescriptions over lifestyle modifications, improperly interfere with the doctor-patient relationship, and favor name-brand medications over less expensive generics.
According to FDA regulations, a manufacturer, packer, or distributor is required to give the public information that is materially complete and fairly weighs the drug’s risks and benefits. But as time went on, the FDA’s regulations allowed pharmaceutical companies to omit some information, especially in broadcast advertising, and the amount of advertising from drug manufacturers increased dramatically in the last few decades.
The current regulatory framework for drug advertising will be upheld by my administration to guarantee that American consumers receive accurate, comprehensive, and balanced information.
Therefore, the Secretary of Health and Human Services must take the necessary steps to guarantee accuracy and transparency in direct-to-consumer prescription drug advertising. One such measure is to increase the amount of information about potential risks associated with using any such prescription drug that must be included in prescription drug advertisements, to the extent that applicable law permits. In order to enforce the Federal Food, Drug, and Cosmetic Act’s prescription drug advertising provisions and to guarantee accurate and non-misleading information in direct-to-consumer prescription drug advertisements, the Commissioner of Food and Drugs must take the necessary steps.
The purpose of this memorandum is to establish no substantive or procedural right or benefit that can be enforced in court or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, agents, or any other individual.
Donald J. President Trump.
