Every day, thousands of individuals worldwide lose their battle with cancer. At

Question

Every day, thousands of individuals worldwide lose their battle with cancer. At the same time, pharmaceutical companies and drug manufacturers are racing to develop and test new drugs that may one day save the lives of individuals who would otherwise succumb to their disease. Often, it takes years, sometimes even more than a decade, and millions of dollars to bring the drug to the open market. Once the drug has been made, it must be approved by the Food and Drug Administration (FDA) for distribution and this only occurs after a series of well-controlled drug trials are completed in human populations. There have been several stories in the news over the past decade of individuals with terminal disease requesting use of a drug that has not yet been approved by the FDA.

Should a drug company be forced to provide an unapproved drug for compassionate use by the FDA or should the company be able to decide on an individual basis when to release its drug?

Be sure to support your response with >10 quality sentences. Be sure your response is fully supported with a detailed explanation of your logic.

Explanation / Answer

FDA should regulate the expanded use of lifesaving drugs showing promising result in final stage of drug development as those patients not eligible for enrolment in clinical trials sponsored by the company may not have fair chance of getting the medicine through company sponsoring trials. Companies sponsoring the trial generally not interested to extend the use of the medicine beyond the criteria of their studies. Some sponsored clinical trials criteria are very stringent or aiming particular group of people. Sometimes sponsored clinical trials criteria are biased on adulthood age. Expanded use of lifesaving drugs don’t include clinical trial result thus not in favour of company. Expanded use of lifesaving drugs puts monetary burden on sponsoring company. Expanded use of lifesaving drugs don’t aid in marketing or promotion of that drug. The price of the lifesaving drug is not regulated before approval. The drug company usually don’t have informed consent for those beyond the study criteria. Most of the needy patient may be simply out of the study criteria because they are beyond the study area, age group or the time of the study period.

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