Prescription Justice is a non-profit organization dedicated to helping Americans who are struggling or fed up with the high cost of medication. Prescription Justice formed in 2015 in response to new regulations that gave the FDA more authority to destroy prescription drugs imported by Americans for their own use. In 2014, about four million Americans imported medication for personal use because of drug costs. While the practice usually violates the law, people receive their orders over 99% of the time and have never been prosecuted for doing so. Prescription Justice provides guidance to consumers in the event their imported medications for personal use are seized by the government. We use the phrase “personally imported” or “personal use” because our efforts to help do not extend to commercial or wholesale importation of medication for resale. Unlike individuals importing medication for their own use, people who illegally import medication for resale and distribution are often prosecuted.
Our uniting purpose is to empower consumers to defend their personally imported prescription drug orders if the FDA refuses to allow their shipments of lawfully manufactured, prescribed medication. If the FDA refuses to allow your imported medication to enter the country, they must send you a letter explaining why and offer you the opportunity to defend your prescription drug order. The process of defending your prescription order is referred to as “submitting testimony.” Prescription Justice helps you do that. Prescription Justice also advocates for regulatory and legislative reforms to improve access to lower cost medication from other countries and to lower drug prices domestically, which would make it less necessary for people to buy medication from foreign pharmacies.
Prescription Justice’s board of directors is comprised of doctors, lawyers, activists and experts in drug affordability and prescription drug importation. Meet the board by clicking here. We are not your lawyers but have worked with lawyers to develop legal and other arguments that you can use if you have received a letter from the FDA that your imported medication is subject to destruction.
Prescription drugs cost on average 50% less in other rich countries. Sometimes the price differentials are over 90%. The reason is that drug prices are subject to different interventions, policies, and controls in most other countries that keep prices much lower for the same drugs sold in the U.S.
The answer may surprise you, but no. Under many circumstances, it is expressly legal to import FDA-approved drugs. Eighty percent of the active pharmaceutical ingredients (meaning the main drug) used to make the medications sold in American pharmacies are imported. Forty percent of the prescription medications you buy at your local pharmacies are imported as well. However, it is likely to be technically illegal for YOU to import a medication for personal use, as discussed in the next section.
The FDA says that under most circumstances it’s illegal to import medication for personal use. That’s because only “FDA-approved” drugs can be lawfully imported (the ones eventually sold in U.S. pharmacies). Most medications imported for personal use that will come from a foreign pharmacy will not meet the definition of FDA-approved drug – EVEN IF IT’S THE SAME MEDICATION.
In consultation with lawyers who are experts in prescription drug importation laws, we have devised arguments that may help you get your medication back. For instance, by providing certain evidence, such as having a prescription and a copy of the U.S. label of the drug, you may be able to bring your imported drug into compliance with FDA regulations. Or you may be able to convince the FDA to release your medication because you know that it’s a lawfully manufactured drug for which you have a prescription and you cannot afford it at your local pharmacy. Remember, unless it’s a counterfeit or otherwise bad drug, taking your real, prescribed medication away is unethical, at cross purposes with the FDA’s mission, and bad for your health.
No one has ever been prosecuted for importing small quantities of medication for personal use. Watch Marcia Crosse, PhD, director for the Health Care Team at the U.S. Government Accountability Office (GAO) explain FDA’s personal drug importation policies.