As a policy matter, how should the FDA handle drugs for life-threatening diseases?

As a policy matter, how should the FDA handle drugs for life-threatening diseases?

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May 15, 2022
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Should the Terminally Ill Be Asked to Await FDA Approval of Last-Chance Treatments?

Facts

Mrs. Barnett is a seventy-three-year-old widow who has just been diagnosed with ovarian cancer. Because of the lack of adequate screening procedures for this type of cancer, Mrs. Barnett’s cancer has long gone undetected and has progressed considerably.

Dr. Jason, Mrs. Barnett’s doctor, will perform immediate surgery, but the surgery will not cure the cancer. He has recommended that she undergo rigorous chemotherapy on a monthly basis for eighteen months following surgery. Thereafter, an exploratory operation can be conducted to assess the success of the treatment. The proposed chemotherapy will cause severe side effects, including nausea, oral lesions, and complete hair loss.

Dr. Jason has informed Mrs. Barnett and her two daughters, June and Sarina, that although chemotherapy will defer their mother’s immediate death, her chances of a recovery are slim. Dr. Jason stated that while, on average, one in three patients undergoing such treatment could expect to recover, he believed Mrs. Barnett’s recovery was highly unlikely. A second opinion from a reputable cancer treatment center confirmed Dr. Jason’s diagnosis and recommendations for treatment.

Sarina has heard of an experimental cancer drug being tested in Europe. Thus far the results seem promising. Though the drug may be obtained in Europe, it is not yet legal in the United States. The Food and Drug Administration (FDA) has just begun to review the drug, but it will be years before the drug could receive FDA approval.

Sarina is strongly opposed to the painful regimen of chemotherapy that has been proposed, particularly because the treatment seems futile. She wants to fly to Europe, obtain the experimental drug, and return with it to the United States. Mrs. Barnett is much too ill to travel. June, on the other hand, is opposed to any course of treatment that does not have the approval of the FDA. Mrs. Barnett, who is weak and confused, is looking to her daughters for guidance.

Social, Policy, and Ethical Considerations

As a policy matter, how should the FDA handle drugs for life-threatening diseases?

Answer and ExplanationSolution by a verified expert

Explanation
Well Explained.

Answer
No, the Terminally III should not be asked to wait for the approval of the FDA because clearly, these people have serious diseases that will lead to their death; the first thing to focus on should be to try to save their lives. Besides, there are some drugs in the United States which have never been approved by the FDA.
As a policy matter, the FDA should make the approval for drugs of life-threatening diseases to undergo shorter phases and take a short time before being approved. They should quickly approve the drugs because they have the mandate to base the effectiveness of the drug on just a "surrogate endpoint," This could include a blood test or simply X-ray results instead of waiting for the results of the clinical trial.

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