Biotech Values

[zipjet]

>>[“Much of the argument for why we are proposing
to invoke pre-emption seems to be based on a false
assumption that the FDA approved labeling is fully
accurate and up-to-date…”]

That confuses the issues. {understand not DD doing that}

The public policy question is whether a drug company should be burdened with costs/liabilities for undesirable effects of a drug* whose utility/safety has met the standards of FDA and whose properties in detail have been described by FDA in the label.

Keep in mind that many of the cases brought are about the label - the theory being that the drug company "failed to warn" of the risks. Yet, the drug companies are prohibited from describing risks differently than the label - they can neither warn of greater nor lesser risks.

Preemption in this context says that since the drug company cannot vary the warning, it cannot be sued for risks that may be perceived to differ.

If Congress wants to widen or narrow the liability of drug companies for their products, then that is the appropriate forum for the balancing of interests to take place.

ij

* By "drug" here I mean the precise drug, should the company produce a compound that varies from the approved "drug" then liability would easily attach.