• jeffreypkiplinger

Bypassing FDA Approval

There's a nice, concise review of considerations for approval of inhalation drug products in the Asian Journal of Pharmaceutical Sciences. The paper can be found at https://bit.ly/2QkleGU. Shuguang Hu and coathors get right to the heart of how an inhaled drug is approved: the device coupled with the drug formulation are evaluated as the product. Currently approved products are delivered by metered dose inhalers, dry powder inhalers, and nebulizers.

So did anyone else find the lack of oversight of vape pens disturbing? Vape pens have been used to deliver - and this is just a short list of "legal" uses, varying by jurisdiction - nicotine in toxic doses, cannabidiol despite its indeterminate controlled substance status, THC and other cannabis extracts, and several synthetic cannabinoids of dubious safety. In addition, any drug that dissolves in a vape e-liquid (usually PEG or a similar fluid) may be in theory dosed with a vape pen. Heroin, oxy, cocaine free base, DMT, etc. Maybe just about anything in the Shulgin archives.

How did the agency drop the ball on this, considering their oversight of tobacco and food industries? In theory, you could make a sealed nicotine vaporizer device that might be of value to smokers trying to quit, and that could not be used (without disabling it) to deliver a DIY formulation. But allow an open source inhaled drug delivery device on the market without any approval process?

I've been thinking about this for some time, and this is just the beginning of a line of thought. If the process for drug product approvals is weakened by such precedent, and the agency relinquishes its oversight responsibilities bit by bit with each such omission, what can we do in a new unregulated world of drug product development?

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