A nurse is discussing generic and trade drugs with a client. The client wants to know why it takes so long for trade drugs to become available in the generic form, which are generally cheaper. What is the nurse's best response?
1. It takes 17 years for all pharmaceutical companies to develop a generic version of the drug.
2. It will take 17 years of clinical trials to approve the drug.
3. Sole ownership of a drug allows the pharmaceutical company to earn back the money spent to develop the drug.
4. Animal testing must continue for 10 years, then 7 years of human clinical trials, for a drug to be approved.
Correct Answer: 3
Rationale 1: The generic version of the drug is already developed but the copyright of the drug is owned by the pharmaceutical company that developed it for 17 years.
Rationale 2: The length of time for a drug to be approved by the FDA varies.
Rationale 3: Sole ownership of a drug allows the pharmaceutical company to earn back the money spent to develop the drug. For example, if it takes 7 years for a drug to be approved, competing companies will not be allowed to market a generic equivalent drug for another 10 years. The rationale for this is that the developing company must be allowed sufficient time to recoup the millions of dollars spent in research needed to develop the new drug. After 17 years, competing companies may sell a generic equivalent drug-using: a different name, which the FDA must approve.
Rationale 4: A drug can be approved in a much shorter period of time, and animal testing does not last 10 years.
Global Rationale: Sole ownership of a drug allows the pharmaceutical company to earn back the money spent to develop the drug. For example, if it takes 7 years for a drug to be approved, competing companies will not be allowed to market a generic equivalent drug for another 10 years. The rationale for this is that the developing company must be allowed sufficient time to recoup the millions of dollars spent in research needed to develop the new drug. After 17 years, competing companies may sell a generic equivalent drug–using a different name, which the FDA must approve. The generic version of the drug is already developed but the copyright of the drug is owned by the pharmaceutical company that developed it for 17 years. The length of time for a drug to be approved by the FDA varies. A drug can be approved in a much shorter period of time, and animal testing does not last 10 years.
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