Lawsuit against Solvay Pharmaceuticals

Phyllis Gardner comments on the lawsuit against Solvay Pharmaceuticals: "This is precisely why one does not want a lessening of FDA-mandated controls on drugs, including imports. Solvay is an international chemical and pharmaceutical company headquartered in Brussels, employing more than 31,000 worldwide. They must have been attempting to market for "off-label" use, i.e. the use of a drug for an indication that has not been FDA-approved. This is strictly forbidden in the US, though marketers will attempt to skirt the issue to avoid the costly clinical trials to prove efficacy in a drug that was approved for another indication. This practice is particularly common in oncology, where an antineoplastic is approved for one type of cancer, and oncologists will try it in other types of cancers without going through the clinical trials to prove efficacy. Part of the problem is the cost of clinical trials, and part is the perceptions of patients when they are asked to undergo a placebo-controlled clinical trial for their cancer. When the drug is already approved, the patients are very unhappy to be randomized to the placebo group. The off-label marketing of a drug for "hot flashes" is not analogous, since this is hardly a life-threatening condition".

RH: Doesn't Solvay have to meet the European equivalent of FDA tests? It would simplify things if the EU and the US agreed on identical tests.