Accessing Non-FDA Approved Drugs for Individual Treatment

The U.S. Food and Drug Administration (FDA) is responsible for evaluating and approving drugs based on their safety and effectiveness. However, not all applications receive approval— about 58% of drugs under standard review pass the rigorous process. Many treatments fail to meet FDA requirements, even if they are successfully approved and available in other countries.

For patients who require a drug that is approved abroad but not in the U.S., there is a potential solution: the FDA’s Personal Importation Policy. This special pathway allows individual patients to access non-FDA-approved medications under strict conditions.

When Can a Non-FDA Approved Drug Be Imported?

A healthcare professional may help a patient obtain a foreign-approved drug if:

1. The drug treats a serious condition with no effective U.S. alternative.
2. It is not marketed or promoted in the U.S.
3. It poses no unreasonable risk to the patient.
4. The patient confirms in writing that it is for personal use (up to 3 months) and provides either a U.S. doctor’s details or proof of ongoing treatment abroad.

Why Is This Exception Important?

Many patients begin treatments abroad due to unavailability in the U.S. If they return home and their therapy is not FDA-approved, they may face a sudden halt in treatment. This policy offers hope for patients with serious conditions who otherwise have no viable options in the U.S.

While this is not a general approval process, it provides a lifeline for those in exceptional circumstances, ensuring that medical treatment can continue when no alternatives exist domestically.

(source: FiercePharma)

Author: Laurens Gerholt