The recent incident with a pharmacy compounder inadvertently spreading fungal meningitis to customers has brought back the discussion of how much regulatory scrutiny should be applied to pharmacy compounders.
The right question to be debating is how large of a market should any product be allowed to capture without being under the full purview of FDA regulation? The problem that recently occurred was fundamentally caused by a manufacturer attempting to out-strip the confines of what has traditionally been a small-market business plan.
FDA typically lightens regulatory burden when small numbers of people are affected by a particular product. Just as FAA doesn’t regulate personal plane owners in the same way it regulates United, FDA doesn’t regulate LDTs or pharmacy compounders in the same way it does Pfizer. This is because the assumption is that LDTs and compounded products affect a relatively small number of people who are unlikely to be helped without this enforcement discretion.
It seems to me the problem isn’t whether FDA regulates LDTs or pharmacy compounders. The problem is deciding when the number of people affected by a product (therapeutic or diagnostic) warrants more scrutiny from regulatory authorities. When does the profit-potential of bypassing regulation become strong enough that we need government to help balance the equation by insisting that standards be met?
In the case of the pharmacy compounder that spread fungal meningitis, they were actively trying to increase the market for their product. But they were not pursuing changes (i.e., high levels of automation in manufacturing) that would have disqualified them as a compounder. The same measures that likely would have avoided the contamination of the product.
The debate on whether FDA should regulate LDTs seems to have stalled. I’m wondering if re-framing the question in terms of market-size requirements (which could work to the advantage of kit-manufacturers as well) could re-invigorate the discussion.