Safety and effectiveness of foreign prescription drugs

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Reference no: EM13774315

Dewey Cheatham is the new Vice President of Marketing for a large online search engine company, Pottstown Innovative Enterprises (AKA, PIE). Dewey has been doing some research into how he can increase the Company’s revenues and thereby really impress the Company brass. During his research he came across an article about Brazilian pharmacies looking for an advertising vehicle to tap into the U.S. consumer market. Further research reveals that this could be a billion dollar venture and if PIE plays its cards right, it could make a substantial amount of money given its extensive advertising network. Dewey is super ecstatic about the possibilities and is salivating over what this could mean for his career with PIE.

Before Dewey pulls the trigger on this, he decides to consult with his legal department. The legal department tells Dewey the following:

1. The shipment of prescription drugs from pharmacies outside the United States to customers in the United States may violate the Federal Food, Drug and Cosmetic Act and in the case of controlled prescription drugs, the Controlled Substances Act.

2. The FDA cannot ensure the safety and effectiveness of foreign prescription drugs that are not FDA-approved.

3. Imported drugs typically do not meet FDA’s labeling requirements and may not have been manufactured, stored and distributed under proper conditions; and may not have been dispensed in accordance with a valid prescription.

4. The government has historically been very lax in enforcing the laws in this area and legally there are a few gray areas; therefore the risk of any prosecution may not be significant.

After the consultation with Legal, Dewey is confused as to what his decision should be. What do you think Dewey should do?

Reference no: EM13774315

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