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.

23 Comments On “Rule regarding the destruction of imported medicine released”

  1. This is the result of lobbying by Big Pharma who spends over 6 billion dollars a year lobbying our lawmakers! They are so damn greedy, they pose a threat to our health! whats going on. Don’t take my word for it, go to Fierce Bio or Fierce Pharma and read what really goes on in the drug industry.

  2. And what makes you think they even care? Money makes the world go round not sick people. You tried to appeal to their humanity unfortunately they don’t have any.

  3. There is no way the amount that comes across the borders is even remotely hurting them financially.. It is pure greed and people cant get what they want or need. Im tired of the govt telling me what i need for my protection. Give me the facts and let me make my own decision. I hope the govt will not actually do the dirty work for big pharma as they dont help the people at all with there meds.. Its crazy..

  4. Why did Obama sign this? How can our government prevent its people from acquiring needed meds.? Why should they care where we get them. It should be no concern of theirs. I’m sick of this country and I feel so helpless. It’s wrong.

  5. You’re right: this is so wrong. This bill was signed because it was a tiny portion of a much larger bill regarding reauthorization of the FDA. We’re anxious to see if they will enforce it considering all the public and media outcry about drug prices, and large public support for legalizing importation. We want to hear from you if your meds are confiscated. We will mobilize to fight and we need all hands on deck.

  6. You’re right, it’s crazy. And greed is leading the way. We’re hopeful that all the media attention of late around drug prices leads to some changes. Of course, we need consumers to speak out to Congress about the issue too.

  7. We have to hope that humanity wins out in the end. It’s the only thing that keeps us going! If we all band together, we’re a powerful force to be reckoned with.

  8. Yes, you’re right. It’s disgusting how pharma influences our elected officials and ultimately our laws. Agreed that Fierce Bio and Pharma are great resources. We also recommend Pharmalot.

  9. In this, Julie, you ARE helpless. You don’t own your representatives, Pharma does. Now, please, just sit down and hush up.

  10. I have an account at CanadaDrugs.com, where I currently maintain three live prescriptions. I haven’t needed to use them since the ACA went into effect last year, as my medications are now covered by insurance and I can source them locally, although for several years just prior to the ACA, Canada Drugs was an essential source of medications that I would not have been able to afford otherwise. I certainly intend to keep my account with them active, as a hedge against any unanticipated interruption of my medical coverage (as happened abruptly eight months ago, due to a brain-dead clerical error by someone at my state health exchange).

    To say that I am hopping mad about this Section 708 would be an understatement. A corporation without sufficient government regulation is like a cancer cell. It is programmed to do one thing, and one thing only: Grow. And grow. And grow – without any consideration of the effect its growth may have on the rights and privileges of others. Left to its own devices, it will become malignant, and will ultimately destroy the entire economic, social, cultural and environmental infrastructure in which it exists – just as a cancer will grow, metastasize, and ultimately kill the entire body, or a parasite will ultimately kill its host.

    Whether it is merciless price-gouging by Big Pharma, or indiscriminate flouting of our environmental laws by Big Petro, or the near destruction of our entire economy by Big Money on Wall Street, I believe America has reached a tipping point. It is time for the people to fight back, and fight back hard. If we don’t, we may soon lose the ability even to fight back at all. America will then devolve into a state of corporate Feudalism, the most sophisticated banana republic on earth.

  11. The Democrats are in bed with Big Pharma because of all the millions of dollars of contributions/lobbying and god knows what else!

  12. To be fair, it’s not just the Democrats, it’s both parties. Pharma will give to the front runner of either party to make sure they have a say in future decisions. Check out the Center for Responsive Politics website for more info: https://www.opensecrets.org/industries/indus.php?ind=H04

  13. I depend on medications that are either unavailable or prohibitively priced in the USA for my basic daily functioning in life. Otherwise I am totally disabled, and my quality of life is not worth living. If the medications i order for personal use, necessary for my well being, are ever stolen out of the mail by the FDA acting outside the bounds of the US Constitution and Due Process, I will sue the FDA in small claims court for illegal search and seizure, and I will set up with remailers to effectively prevent any further seizures of my property.

  14. When the law itself becomes a tool, not to promote and protect the public interest, but to promote and protect corporate interests at the expense of the public interest, that is the point at which the law has lost its moral authority. It’s no longer about right and wrong, or about constitutional and unconstitutional. It’s only about who has the money and the power – and who does not.

    Ya gotta do what ya gotta do.

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