Earlier this year, Indiana became the 25th state to pass “Right to Try” legislation that enables terminally ill patients to use medications that have not gained Food and Drug Administration (FDA) approval. As explained in The Indiana Lawyer, the state law shields providers from liability when prescribing unapproved drugs to patients who have no other treatment options, as long as the doctor, patient and provider all consent to the medication.
Amy Judge-Prein, Faegre Baker Daniels counsel, said that the law presents a dilemma to pharmaceutical companies.
“When a drug is not approved under our federal laws and regulations, then it would be against the law in the strictest sense to provide that drug to a patient for use,” Judge-Prein said. “The only way a manufacturer can supply an unapproved drug is within a recognized exception, such as within a valid clinical trial or through one of the FDA’s expanded access programs.”