Question

Thoroughly answer the following questions in question/answer format.

1) What is the purpose and method of Clinical Trials in the Drug Approval Process?

2) Why did the U.S. government take steps to allow for expedited review of generic drugs, and what is necessary for generic drugs to receive approval?

3) Why was the early proprietary medicine trade a threat to public health?

4) What is the main criticism of Medicare Part D?

5) What are at least ways that the U.S. government supports the pharmaceutical industry's research and development of prescription drugs.

Answer 1

1) What is the purpose and method of Clinical Trials in the Drug Approval Process

For approval of any drug, medical products or formulation you require scientific efficacy and safety data which is unbiased, scientifically generated and according to the ethical and safety guidelines. For this purpose clinical trials are conducted where the said drug or medicinal product are tested on human volunteers and the safety and efficacy data is generated in clinical trials. So clinic trials work as the experiment and demonstrative proof of the drug efficacy and effect in the general population in which the drug is intended to use. So clinical trials are essential for obtaining regulatory drug approval in the process.

2. Why did the U.S. government take steps to allow for expedited review of generic drugs, and what is necessary for generic drugs to receive approval?

Expedited reivew if any drug including the generic drug is given approval only in case if emergency situations or in case of public health emergency or crisis circumstances. So if the US government has allowed for the expedited reivew if the generic drug it can be due to their affordability and wider public use. Generic drug have the same formulation and chemical composition as that of approved drugs. But to ensure that the generic drug has the exact same chemical composition of the drug and also performs very similar interns of efficacy, a small generic drug trial is to be performed. So in normal circumstances the generic drug require the trial data to be submitted but in case if public health emergency the expedited approval for the drug could be provided .