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.  These advertisements can mislead the public about the risks and benefits, encourage medications over lifestyle changes, inappropriately intervene in the physician-patient relationship, and advantage expensive drugs over cheaper generics.

The FDA has historically stipulated that a manufacturer, packer, or distributor must provide the public with materially complete information that fairly balances both the benefits and the risks of the drug.  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.  

This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

                               DONALD J. TRUMP