In the past I’ve made the suggestion that FDA certification should be optional and that said certification should provide certain benefits to the company in the form of certain tort immunities. Below, I’d like this post to be a thread to discuss how that might work (specifically the FDA tort immunity part).
My notion for how this might work is that a person has no grounds for suit against the pharm manufacturer for defects or side effects if the manufacturer can show that the approved procedures were followed.
What does this cover? That means, from famous examples, a parent of a thalidomide child has no grounds for suit against the manufacturer because the drug was used for the approved purpose and correctly manufactured. It had unforseen and unintended consequences. Which is, we all agree, unfortunate. But unfortunate occurances a priori do not make for grounds to sue.
What does it not cover? It doesn’t cover uses not claimed. If a drug is produced with specificied (in the FDA approval) uses. If it can be shown that the manufacturer was touting uses beyond the uses mentioned in the approval or for effects not listed … this can provide a ground for suit. Commenter Boonton noted:
One infamous case, for example, was oxycotin which was marketed as impossible to become addicted too.
If the FDA approval documents lack the claim that “it is non-addictive” then claiming the same gives ground for suit. One the other hand, if it did, then there would be no standing.
FDA approval processes are expensive. This then gives companies the motive to seek that certification. Today the approval is required, but it buys you nothing except the opportunity to sell product in the US. My suggestion would be to make the approval process more or less optional, but give motive for the company to seek approval. The consumer would realize that the FDA label implies a high level of testing and scrutiny, which is something they might value in a drug.