19 Nov 2015
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Prescription Justice Action Group (PJAG), a new non-profit organization, is here to help bring justice to American consumers who are literally sick from the high cost of prescription medication. New federal regulations and other actions by the government and pharmaceutical industry, particularly toward online pharmacies, threaten access to safe and affordable imported medication. PJAG recently formed to coordinate a response to these developments and to advocate for policies to bring down drug prices here at home.

Its Board of Directors supports new laws and regulations to lower drug prices in the U.S. and opposes current laws and regulations that obstruct access to safe and affordable medication, both domestic and foreign.

Today, we are proud to announce guidance to help American consumers who import lower cost medication for personal use if their prescription orders are intercepted by the U.S. Food and Drug Administration (FDA). For our press release on this new guidance click here.

Public health professionals, advocacy groups, and presidential candidates are up in arms about the high cost of prescription drugs and often view them as a public health crisis. According to a survey by the Kaiser Family Foundation, prescription drug prices are a top healthcare concern among American consumers. Tens of millions of Americans are not filling prescriptions, choosing between food and medicine, and even going bankrupt, all due to high drug prices.

Compared to the U.S., prescription drug prices are on average 50% lower in other advanced economies. According to a survey by the U.S. Centers for Disease Control and Prevention, about five million Americans import lower cost medication for personal use each year because of high domestic drug costs. Despite federal restrictions, Americans are not prosecuted for importing small quantities of prescription medication for their own use.

PJAG’s initial focus is to empower consumers to stand up to a new federal regulation that could threaten their ability to obtain affordable medication. Promulgated under Section 708 of the Food and Drug Safety and Innovation Act of 2012, the FDA has new powers to destroy small quantities of imported prescription medication ordered by individuals for their own use. The new regulation became effective on October 15, 2015.

It’s uncertain how aggressively and arbitrarily the FDA will use its new powers. Fortunately, Section 708 requires the FDA to notify consumers when their imported medication orders are refused and inform them of their right to “appropriate due process” to provide testimony to challenge the FDA’s decision to destroy their medication.

Public comments to the FDA about its proposed regulation expressed serious concerns that the FDA is not providing due process, ignoring the public health costs of Americans being denied imported medications, and not providing consumers with guidance on how to provide testimony. Such concerns, while addressed in the final ruling, were largely dismissed by the FDA.

PJAG is now providing guidance, and is in the process of developing a free online submission platform, to help consumers provide testimony to the FDA and exercise their rights. There are legal, ethical and even human rights arguments that consumers can make to the FDA, which in many cases should serve as a basis for the FDA to release those medications to the consumers who ordered them.

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