Re: Farmas USA
AMRN presenta lo que parece que sería como un recurso de inconstitucionalidad, contra la decisión de la FDA "limiting off-label promotion of such truthful and non-misleading information", por considerar que vulnera la primer ay la quinta emmienda...
AMRN
Once a drug is approved by FDA for a specific use in a specific patient population, physicians may exercise their medical judgment to prescribe the drug for any use in any patient population. It is estimated that approximately 20% of all prescriptions in the United States are used by physicians for such “off-label” indications. FDA has taken the position, however, that federal law prohibits pharmaceutical companies from proactively promoting data to the medical community regarding off-label uses—even when such information is accurate, not misleading and reflective of accepted medical treatment.
