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Pros And Cons Of Direct-To-Consumer Advertising

3974 Words16 Pages

Marisol Alviso
Professor Russell Moses
CAPS 4360
19 June 2015
Should the Food and Drug Administration (FDA) continue to allow direct to consumer advertising (DTCA)?
I. Introduction
Direct-to-consumer Advertising is directed to the general public to spread the word on pharmaceutical drugs and medical goods. This business has grown rapidly since 1997 and is now the biggest source of health communication that reaches the public (Ventola). Although DTCA has been legal in the United States since 1985 it wasn’t until the Food and Drug Administration (FDA) relaxed its regulations on DTCA in 1997 that the issue became more prominent. In 2008 alone the US has spend almost $5billion in this industry ("Direct-to-consumer Advertising under Fire"). Since …show more content…

This made sure that manufacturer were taking safe guards to make sure their products would do no harm to consumers before they marketed them. “By the 1930s it was widely recognized that the Food and Drugs Act of 1906 was obsolete, but bitter disagreement arose as to what should replace it. By 1937 most of the arguments had been resolved but Congressional action was stalled. Then came a shocking development--the deaths of more than 100 people after using a drug that was clearly unsafe. The incident hastened final enactment in 1938 of the Federal Food, Drug, and Cosmetic Act, the statute that today remains the basis for FDA regulation of these products” …show more content…

Merell Company submitted a new drug called Kevadon, a sleeping pill that had been available in Europe since 1956, to the FDA. The US FDA reviewed this medication and believed that there was not enough data to prove that this medication was safe so he did not approve it to be sold. Then this same drug was suspended from the German market in 1961 for showing birth defects in newborns. The strict regulations of the FDA led to the right decision according to the public, which fostered support for stricter guidelines (108). Congress then passed the Kefauver-Harris Amendments in 1962 gave the FDA new regulations to abide by. This law required manufactures to provide proof on safety and effectiveness of the drug, it gave the FDA 180 days to evaluate and decide on whether they allow it or not. It made sure that new drugs were being evaluated before marketing and manufacturers had to keep records on any side effects that the drug caused that they may have missed and promptly report back to the FDA ("50 Years: The Kefauver-Harris

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