Medical Products Liability, BBS Assignment #3 SPL Paper

SPL
Name
Institution of Affiliation
Date
1. What ad did you choose and where did you find the ad (TV, online, etc.).
LUNESTA is a commonly marketed drug both in the internet, magazines, televisions and many other media available in the USA. People have perceived LUNESTA as to cure insomnia with a single pill overnight. The particular advert I selected shows a man in a jovial mood still covered in cozy white bed sheets as warm sun rays come through the window. The man wears a pleasant and jovial expression on the face which appeals to the message the advert is trying to relay to viewers. The man shows no sign of distress, and he is ready to kick start his day with a smile. Certainly, this drug advert is trying to attract attention and emotionally appeal to its customers. In this case, the drug was basically under scrutiny in a page of the New York Times, the advertising section whereby an outline of the information displayed was on both its advantages and side effects. The drug has become a subject of concern with the manufacturers reportedly accounted to spending hundreds of millions of dollars on marketing the drug (Singher, 2009).
2. Do you think the ad meets the FDA regulatory and guidance requirements? Why or why not?
Yes, I perceive that the advert on LUNESTA is within the jurisdiction stipulated in Section 503 C (2) of the Prescription Drug Marketing Act of 1987. It says:
"(2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term 'coupon' means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with section 503(b).
Prescription Drug Marketing Act of 1987 [S 503 (2)(c)]
The sale of the drug is authentic and within law, since it acknowledges to the customer that if any symptom unintended is observed, the client should report it immediately to the FDA (U.S. Department of Health & Human Services, 2010).