In 1999, the Drugs-R-Us began testing its new drug, Reduceo, a medicine to help people lose weight. Tests looked promising and, in 2006, the company applied to the FDA for approval to market Reduceo as a prescription drug. In March 2009, the FDA granted Drug-R-Us approval to market Reduceo. Reduceo was sold with some "diet enhancing" cookies that contained no drugs but were claimed to help

Question

dieting with Reduceo. Frank saw an ad for the new drug. The Reduceo ad stated that it was a "wonder drug" and "tests prove it is the safest weight reduction drug on the market today!" Frank was interested and made an appointment to see his doctor. Frank's physician prescribed the new drug for his patient. Frank had no success using other weight-loss drugs, and dieting and exercise seemed ineffective. Frank took Reduceo from June until the end of August and lost 25 lbs. He also ate Reduceo's cookies. He was delighted with his weight loss, but was concerned because dots appeared before his eyes, causing disorientation. One day, the dots appeared before Frank's eyes while he was driving. He became disoriented and hit a tree and was seriously injured. He sued Drugs-R-Us, alleging negligence in manufacturing and inadequate warning of possible effects, as well as for deceptive advertising. When Drugs-R-Us submitted Reduceo for FDA approval, what standard would the agency have applied in it approval process? Drugs-R-Us would:
a. have to submit evidence that Reduceo was produced in a non-negligent manner
b. have to submit evidence that Reduceo would never cause an injury to any consumer c. have to submit evidence that Reduceo presented only a de minimis risk of harm
d. have to submit evidence that Reduceo was safe for its intended use
e. not have to submit any evidence to the FDA because the 1938 Act did not require such a submission

Answer 1

d