The Prescription Justice Action Group (PJAG) announced the publication of guidance on its website, www.pjag.org, to help American consumers challenge the U.S Food and Drug Administration (FDA) if their imported prescription drug orders are intercepted and threatened with destruction. Due to the high price of medicine in the U.S., about five million Americans import medication for personal use each year according to a survey by the U.S. Centers for Disease Control and Prevention. Many of the orders are placed using online pharmacies.
Despite federal restrictions against personal drug importation, Americans have never been prosecuted for importing small quantities of prescription medication for their own use. However, a new federal regulation (authorized by Section 708 of the Food and Drug Administration Safety and Innovation Act of 2012) gives the FDA expanded authority to destroy personally imported medication.
PJAG’s website educates consumers about their rights and offers step-by-step written guidance to use in responding to FDA notices of prescription drug confiscations. With permission from consumers, PJAG will also publicize cases where medications were taken away by the FDA.
While the FDA claims that the new regulation will protect patients, there is concern that the law thwarts access to critical medications. Currently, very few imported personal prescription orders are confiscated, but to what extent and how the FDA will use its new powers is unknown.
The law requires that the FDA notify consumers if their prescription drug orders are detained and that they have the right to appropriate due process to challenge FDA’s decision to destroy their medication. People affected by the new regulation may be unaware of how to exercise their rights.
PJAG’s legal advisers believe it is possible for consumers to persuade the FDA to release detained or refused medications by presenting the following testimony:
valid prescriptions written by their licensed U.S. healthcare providers;
evidence that their import is a genuine prescription drug;
evidence that the imported drug was made in an FDA-registered establishment;
a copy of the U.S. label for the drug (easily found online) to show that they are aware of the FDA’s required warnings and adequate directions for use; and
a statement affirming that the imported medication is unaffordable to them domestically.
Gabriel Levitt, president of PJAG, remarked, “Tens of millions of Americans are not filling prescriptions, choosing between food and medicine, and facing bankruptcy. We need to lower drug prices right here at home, not confiscate people’s imported and affordable medications and threaten their health. We hope that our guidance helps consumers get the medication they need and that the Prescription Justice Action Group can help raise awareness that people’s medications may be taken from them, and destroyed, by their own government.”
About the Prescription Justice Action Group
PJAG brings together doctors, lawyers, public health advocates, and companies dedicated to bringing down drug prices and helping people get the medication they need. It is a 501c4 non-profit organization. PJAG received initial funding from individuals and PharmacyChecker.com. The following is a listing of PJAG’s Board of Directors and their affiliations:
Stephen Barrett, M.D. (Quackwatch)
David Belk, M.D. (TrueCostOfHealthCare)
Tod Cooperman, M.D. (ConsumerLab.com and PharmacyChecker.com)
Douglas Grover, Esq. (Schlam and Stone)
Lee Graczyk (RxRights.org)
Gabriel Levitt (PharmacyChecker.com)
James “Jake” Nadler (Berkshire Prescription Services)