Rule regarding the destruction of imported medicine released
The final rule related to Section 708 of the FDA Safety and Innovation Act has been released and goes into effect on October 15. This rule establishes a process for the seizure and destruction of imported prescription drugs valued at $2500 or less.
To refresh your memory, Congress passed the FDA Safety and Innovation Act (S. 3187) and President Obama signed the bill into law back in June of 2012. Section 708 of the bill changes prescription drug importation as we know it.
Typically, the FDA has looked the other way, allowing packages of prescription drugs ordered online from foreign pharmacies to be delivered. But this new provision gives the government the authority to destroy personally imported drugs at their point of entry.
The rule went into effect primarily because it was tied up in a must-pass FDA reauthorization bill that had wide bipartisan support, despite the fact that many expressed concerns about the 708 provision.
We enlisted your participation in actions to protect and ensure access to affordable imported medicine. Through our online system, our supporters sent:
- 1683 letters to their senators, urging them to speak out against harmful section 708 rules
- 1649 letters to Secretary of Health and Human Services Sylvia Burwell regarding harmful section 708 rules
- 823 letters to senators, urging them to support:
We have also worked with various organizations and members of Congress to encourage them to speak out against 708. Here are some examples.
- Our ally Congress of California Seniors sent this letter to Leslie Kux, assistant commissioner in the Office of Policy at the FDA (and copied the letter to each member of California’s congressional delegation) with a series of questions regarding how Section 708 will be administered. They received no response.
- Senators David Vitter, Dean Heller, Chuck Grassley, and Angus King Jr. sent a letter to Margaret Hamburg (then-commissioner of the FDA) about their opposition to 708 citing the “potential health threat to hundreds of thousands of Americans who receive their affordable drugs from safe, licensed and legal pharmacies in Canada.”
- Representative Keith Ellison sent a letter to the FDA with constituent comments regarding concerns about how the proposed rule would affect them.
RxRights, along with others, made a public comment regarding our concerns with the (Administrative Destruction of Certain Drugs Refused Admission to the United States) while it was pending. Specifically, the real financial and health costs the rule may have on consumers, including some of our most vulnerable populations: lower income Americans and senior citizens.
But the FDA largely ignored our pleas to revise the rule to accommodate the nearly 5 million Americans who import their needed medications each year. What do we do now? We have no choice but to wait to see how they go about enforcing the rule. And then—with your help—we will respond. Please contact us immediately if you or anyone you know has their medication seized.
There is a precedent for success if we work together! Some of you may remember that in 2006, the FDA and Customs launched a major campaign to seize and deny Americans their personally imported medicines at the ports of Miami. Then an ad-hoc group of American consumers, advocacy groups, and elected officials worked together and were able to counter that effort. Please be ready for action, we will likely be calling on you for help soon.