US prescription-drug advertising transparency directive

MEMORANDUM FOR THE SECRETARY OF HEALTH AND HUMAN SERVICES THE COMMISSIONER OF FOOD AND DRUGS 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...