scholarly journals Does Direct-to-Consumer Prescription Drug Advertising Achieve a Mechanistic Fair Balance? A Critical Review of the Literature and Debate

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Wan S. Jung
1999 ◽  
Vol 25 (1) ◽  
pp. 149-167
Author(s):  
Tamar V. Terzian

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.


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