Please review the attached article about the deaths and risks associated with the use of Viagra. When the Food and Drug Administration permits the sale of pharmaceuticals in the U.S. marketplace to what degree should "side effects" be allowed? Does the benefit outweighing the risk all that should matter? Are you surprised that notwithstanding the death of hundreds, that the drug is still on the market? Try to include some examples of other drugs that have been pulled off the market for less risk.

CONSUMER PROTECTION AND ENVIRONMENTAL LAW Law & Ethics Questions Web Exercises 1. Did the FDA exceed its delegated authority under the FDC Act 1. WEB For the complete opinion of this case, g by enacting its tobacco products rules? www.prenhall.com/cheesemancases. 2. Did the cigarette companies come out ahead by the result reached 2. WEB Visit the website of the U.S. Supreme C in this lawsuit? supremecourtus. gov, and try to find docume 3. ETHICS Do you think that the cigarette companies have "bought this case off" Congress? Explain your answer 3. WEB Visit the website of the federal Food and 4. ETHICS Do the state and federal governments have a Administration, at www.fda.gov. stake in cigarette product sales? What economic effects 4. WEB Visit the website www.bwdocs.com. W would a ban on cigarette sales cause to state and federal ments are posted on this website? governments? 5. WEB Use www.google.com to find an article risks of smoking and the difficulty of giving up ETHICS SPOTLIGHT Safety Warnings About Viagra The anti-impotency drug Viagra is prescribed by doctors to male By requiring the new warnings, the FDA hopes patients who cannot have or have trouble getting erections, and it helps such men have intercourse. The drug became successful and risk factors before taking Viagra. is now used by millions of men worldwide. In the United States, the Food and Drug Administration (FDA) approved the drug for use by the Law & Ethics Questions general public. After hundreds of deaths of men taking the drug were reported, 1. Are there risks in taking many of the prescription the FDA investigated and found that men with certain health predispos market today? Can you describe one such drug sitions may be at risk of death if they take Viagra. Therefore, the FDA 2. ETHICS in applying a cost-benefit analysis to the required Pfizer, Inc., the manufacturer of Viagra, to place labels on and marketing of a drug, when is a point reaches Viagra containers, warning individuals with the following conditions to cost (in injuries, side effects, and deaths) exceeds be careful when taking the drug: society? Explain. Men who have had a heart attack or an irregular heartbeat In the past six months Web Exercise Men who have a history of cardiac failure or coronary artery 1. WEB Visit the website of Pfizer Pharmaceutical C disease that caused angina manufacturer of Viagra, at www.pfizer.com. " Men who have significant high or low blood pressure Regulation of Cosmetics The FDA's definition of cosmetics includes substances and preparations altering the appearance of, and promoting the attractiveness of a person, Ex other facial makeup products are examples of cosmetics subject to FD. Ordinary household soap is expressly exempt from this definition. The FDA has issued regulations that require cosmetics to be labeled ingredients, and to contain warnings if they are carcinogenic (cancer-causing dangerous to a person's health. The manufacture, distribution, or sale of adult branded cosmetics is prohibited. The FDA may remove from commerce any contain unsubstantiated claims of preserving youth, increasing virility, growing Regulation of Medicinal Devices In 1976, Congress enacted the Medicinal Device Amendment to the FI amendment gives the FDA authority to regulate medicinal devices, such as hes ers, kidney dialysis machines, defibrillators, surgical equipment, and other herapeutic, and health devices. The mislabeling of such devices is prohibited empowered to remove "quack" devices from the market. 194