New FDA Rule Weighs Heavily on Americans Struggling to Afford Medicine

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Rule would allow for seizure and destruction of medications imported for personal use. RxRights and aging rights groups say it will jeopardize public health.

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This is a dire situation. If the proposed rule is enacted, millions of Americans who import safe, affordable prescription drugs from legitimate international pharmacies will lose a vital lifeline to crucial medicines.

The FDA has proposed a new rule that would allow them to seize and destroy medications imported for personal use from outside of the United States. Consumer and aging rights groups are expressing alarm that the rule will endanger public health.

The proposed rule pertains to section 708 of the FDA Safety and Innovation Act (S. 3187) and would give government officials the authority to destroy an imported drug valued at $2,500 or less that is refused admission under the Federal Food, Drug, and Cosmetic Act. Under the rule, a drug may be destroyed if it “is or appears to be adulterated, misbranded, or unapproved.”

The Centers for Disease Control has said that 2 percent of the adult population—or roughly 5 million Americans—import their medications from another country due to the inability to afford their medications at home.

“Importation is a lifeline for seniors on fixed incomes and those without prescription drug coverage,” says Bob Hines, board chair for Mature Voices Minnesota, a nonprofit working to empower older adults that happens to have a well-established importation program.

“Personal importation offers a critical, viable solution to current medical costs and health challenges in the U.S. The proposed rule will endanger the health and well-being of untold numbers of Americans,” says Dan Hines, publisher of TodaysSeniorsNetwork, a leading informational website on aging issues.

According to the Commonwealth Fund, 50 million Americans did not fill a prescription due to high costs in 2012. Access to affordable prescription drugs may prevent or reduce medication non-adherence, a growing problem in the U.S.

“We regularly hear from Americans who simply can’t afford the exorbitant cost of their needed medications—so much so that we dedicated a portion of our website to telling their stories,” says Lee Graczyk, lead organizer for RxRights, a consumer group concerned with the high price of U.S. prescription drugs.

Testimonials on the RxRights site are grouped by state and feature first names only. Many of the stories specifically refer to drug importation. Lori from Missouri says, “I have just been put on a monthly regimen of six medications. I work for a mail order pharmacy and I cannot afford the prescriptions. Just one of my medications in the U.S. is over $175/month, minimum. Through a Canadian pharmacy, it is almost affordable at under $100. This is a huge issue; people cannot afford U.S. pharmacy prices. Most of us are fixed or lower level income, and we need to be able to continue accessing the lower cost of pharmacies outside the U.S. borders."

The RxRights site also includes information on how to choose a safe online pharmacy. According to Graczyk, RxRights shares the FDA’s safety concerns about the potential for rogue and counterfeit medications. But his group believes that educating consumers about how to identify safe online pharmacies is the best tactic. “Americans have been personally importing drugs from safe and affordable pharmacies in Canada and elsewhere for nearly two decades with no ill effects,” says Graczyk.

RxRights is mobilizing their 82,000 supporters across the country to raise awareness of the consequences the proposed rules will have. Graczyk says he hopes to influence the final rules. “This is a dire situation. If the proposed rule is enacted, millions of Americans who import safe, affordable prescription drugs from legitimate international pharmacies will lose a vital lifeline to crucial medicines.”

RxRights is a national coalition concerned about the high cost of U.S. pharmaceuticals and dedicated to promoting and protecting American consumer access to sources of safe, affordable prescription drugs.

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