Should the FDA Approve More Drugs?

Life can be vexing. Life is not a math problem that has one indisputable correct answer. We are constantly weighing options as we make decisions. How much risk would we tolerate in order to hope to capture a reward? Does an NBA star go for the three pointer or drive to the rim? Does a defense attorney put his client on the stand or leave him mute hoping that the prosecution hasn’t met the required burden of proof? Does a surgeon recommend an operation today or should the patient wait another 24 hours to see if his condition improves without surgery?

All of us struggle where to draw the line. Look at the ongoing debates in the public square regarding national security. While some government officials deny this, most of us acknowledge that there is a tension between guarding our civil liberties and protecting our security. Civil libertarians claim that we can do both, but I believe that trimming civil liberties would provide our intelligence community with more tools to protect us. I am not advocating this, but simply acknowledging what I believe to be a truth. There will never be consensus on where to establish this boundary.

Weighing the Options

The Food and Drug Administration (FDA) also struggles with an analogous issue. They must balance the public’s need for new medicines while protecting us from unsafe medicines. How much testing should a pharmaceutical company have to pursue to satisfy the FDA of the drug’s safety and efficacy? This query is not easily answered. More testing would likely enhance the safety of drugs that the FDA approves for our use, but would result in fewer medicines becoming available to us. Would the public want medicines released sooner that show real promise for conditions such as Alzheimer’s disease, cancer, depression and autism? Would the public tolerate greater risk of unknown side effects of drugs that are released on an expedited track? What would these companies’ legal exposure be here? Conversely, should the FDA’s pathway toward drug approval be lengthened in order to increase the margin of safety?

Desperate patients and their families may demand drugs that have minimal safety and efficacy data. We all understand this. But short circuiting the process means that there won't be high quality clinical trials, often with a placebo arm, to vet the drugs properly. This does not serve the public at large as well as ill patients who deserve effective and safe drugs.

These are tough calls to make. When the FDA deviates from established protocols, the results can be disastrous, as occurred with their botched accelerated approval of Aduhelm in 2021 for Alzheimer's disease.

So, do you want more drugs or more safety?

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