FDA Committee Sides With Big Pharma… Again

FDA’s Pharmacy Compounding Advisory Committee has voted to limit your access to drugs not made by drug companies. Action Alert!

A few weeks ago, we told you that the FDA’s Pharmacy Compounding Advisory Committee (PCAC) was meeting once again to decide whether patients will have access to customized medicines.

True to form, PCAC voted to reject all the substances that came before them (the meeting minutes aren’t published yet, but you can look at webcasts of the meetings here). PCAC, following the FDA’s guidance, voted to reject artemisinin, nettle, ubiquinol, vanadyl sulfate, and nicotinamide adenine dinucleotide.

As we’ve pointed out in previous articles, this is only the latest group of natural substances PCAC has recommended be banned. In almost all cases, the committee has followed the FDA’s recommendation, which is based on very dubious criteria. In some cases, the existence of a commercially available drug is enough to persuade the FDA that a substance does not need to be available to compounding pharmacies, a clear nod to Big Pharma.

The agency clearly does not understand the concept of customized, natural medicines. Mass market “one size fits all” drugs are not meeting patients’ individual needs, and compounding is needed in many cases. Additionally, the agency does not seem concerned that it is eliminating consumer choice.

These are only recommendations at this point. Eventually the FDA will have to issue a formal rulemaking to add or reject substances to the accepted list of “bulk ingredients.” However, unless the trajectory changes, we can continue to expect the FDA to look out for #1, Big Pharma.

Action Alert! In the meantime, if you haven’t already, send a message to the FDA telling them that Congress has instructed them to specify how office use compounding can continue and to clarify that the FDA does not have the authority to limit the interstate dispensing of customized medicines. Please send your message immediately.

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