Opinion: On compounding, the FDA marches to the beat of its own biases

The FDA’s approval of the drug Aduhelm as a treatment for Alzheimer’s disease — despite the recommendation of its own advisory committee against approval — came as a surprise to many. But to me, that decision is the latest in an ongoing pattern of FDA keeping its own counsel and doing things its own way.

I’ve seen this firsthand in its oversight of pharmacy compounding, where the agency has a track record of cutting corners, manipulating processes, and even defying Congress to implement its own agenda.

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