FDA wants to seize and destroy imported Rx drugs

The FDA wants to eliminate your ability to import safe and affordable prescription drugs. They have proposed new rules that would give them the right to seize and destroy imported medicine.

The proposed rules pertain to section 708 of the FDA Safety and Innovation Act (S. 3187). More about section 708. The rules 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. What are the grounds for destruction? If the drug “is or appears to be adulterated, misbranded, or unapproved.”

The language gives consumers the illusion that they can appeal the FDA’s decision. They claim the proposed rule would provide the owner or consignee of a refused drug with:

1)   Written notice that FDA intends to destroy the drug

2)   The opportunity to provide testimony to prevent said destruction

But the cards are stacked against consumers on this issue, as usual. We already know that the FDA considers prescriptions imported from Canadian and other international online pharmacies to be “misbranded” or “unapproved.” It is a mistake to assume that the general meaning of the terms “adulterated” or “misbranded” applies here, because the Prescription Drug Marketing Act of 1988 prohibits drug importation by anyone but drug manufacturers. The fact that personal importation falls outside the allowed parameters of the act means any drug not imported by a drug manufacturer can be considered an adulterated, misbranded or counterfeit drug.

This means personally imported drugs—no matter how legitimate their point of origin—will be targeted. We believe the purpose of this new regulation is to sever your lifeline to safe, affordable prescription medicines from licensed, registered pharmacies outside the U.S. And if taking away needed medications wasn’t harmful enough, the proposed language puts patients on the hook for the cost of storage and destruction of the drugs as well.

Putting an end to importation has been a goal of PhRMA (the drug lobby) and its allied front groups for more than a decade and a half, during which time their predatory pricing practices have made the U.S. into a safe haven for the highest prescription drug prices in the world. In the FDA’s own analysis of the proposed rules, they admit that the seizures will likely benefit pharmaceutical companies “through increases in sales, brand value, and investment in research and development if the destroyed drug is a counterfeit or an otherwise falsified version of an approved drug.” Last we heard the FDA is tasked with protecting consumers, not the pharmaceutical industry’s monopoly.

Big pharma doesn’t need help from the FDA. The pharmaceutical industry already enjoys outrageous profitability at the expense of the American public. Pharma already enjoys a number of questionable competitive advantages that help to boost their profits, including lengthy patent monopolies, direct-to-consumer advertising and the ability to pay off generic competition in order to preserve profits.

While we share the FDA’s purported goal of protecting the American public from counterfeit drugs and rogue pharmacies, section 708 is a flawed approach to guaranteeing the safety of prescription medicines. The FDA has been allowing personal importation for years. If they were truly concerned about safety, why not conduct random testing of imported drugs? This would be more beneficial than destroying shipments of life-saving medications.

The FDA describes the primary health benefit of the proposed rule as “the value of the illnesses and deaths avoided.” We need to draw the FDA’s attention back to the incredible value that importation provides. Over the years, the ability to import safe, affordable medicine has helped preserve the health and welfare of millions of Americans—not to mention their financial security. If this lifeline is cut off, illness and death are the sure results.

Now is the time to speak out about the proposed rules! We’re in the midst of a 60-day public comment period (ends on July 7, 2014). During this time, in addition to preparing a public comment, we will be asking our supporters to take action. Those of you with Senators who have been supportive of importation in the past will be hearing from us via email (be sure you’re signed up for our list). We’ll be asking you to send letters to your Senators asking them to use their influence to ensure the FDA doesn’t proceed with these unjust rules.

27 Comments On “FDA wants to seize and destroy imported Rx drugs”

  1. US Pharma has taken a less than five dollar prescription and turned it into a 8-9 dollars a PILL with the strangest excuse and gobbledegook to enrich themselves at the expense of sick and painful victim’s of gout. This under the radar theft clearly shows what will happen if you take the purchase choice off the table for Americans.
    To say that Canadians would sell dangerous drugs is beyond imagination. It’s about money and theft by fountain pen and bad law.
    Money counting rooms in hell are full and growing….fast

  2. I don’t understand – why do you want “adulterated, misbranded, or unapproved” drugs? Why would anyone want them? What am I missing?

  3. Any foreign drugs (whether legitimate and authentic or not) could be labeled as “unapproved” because they aren’t officially approved by our FDA. Or they could be considered “misbranded” because they feature writing in French and English, as Canadian medications might.

  4. This is horrible!

  5. Then why isn’t the debate about THAT point, rather than opposing the FDA’s ability to block anything at all? The term “officially approved by our FDA” should mean something, and to most it does.

    If you want to drum up support, you should be discussing the key issue, which seems to be WHICH drugs are being blocked, not the law that allows blocking itself – which is clearly needed for the stated purpose.

    I say all this because this campaign sounds exactly like the all-to-common anti-FDA, anti-establishment fight – akin to alternative medicine – against what most see as reasonable regulations to protect us from fake and dangerous drugs. I find it strange that you’ve made it entirely about total deregulation rather than properly defining the word “misbranded” in the law. It’s kinda Tea-Party-ish (anarchist), if you know what I mean. But mostly, it seems you’re not communicating the real issue in your pleas for support.

  6. Sorry if you have found some of our messages to be misleading. It’s a difficult issue to try to simplify this issue in an email. That’s why we link to longer blog posts for those who want more information. We support FDA actions to ensure the safety of our medicine. But right now, the proposed language of the rules would block ALL foreign drugs, whether legit or not. This is a huge concern to anyone who depends on imported drugs. We want the FDA, HHS and our legislators to give this issue more careful consideration before enacting rules that would effectively cut off access to personally imported drugs.

  7. I tend to agree with the overall sentiment (I’ve supported this campaign so far), which is why it’s so important that your message be more clear than it is. It’d be sad to lose this battle to murky language that comes off as being paranoid of “big gubment”.

    I’d like to see specific examples of which drugs would/are being blocked, and why they shouldn’t be – can you show any? That would strike home for anyone familiar with the drug, and very simply demonstrate the problem to all. More importantly, it allows an objective analysis by anyone of whether or not the drug is truly “legitimate” and safe, instead of relying on fearful emotions. For example, if you’re talking about alt-med treatments of any kind, then I and many others would strongly oppose your efforts, otherwise, I’m all for it like most people should be. The problem is that there’s no way to tell which side you’re on – that I can see.

    I think the issue would be better served and supported by more if you led with a more specific and targeted tack. My two cents.

    EDIT: I’ll just add that the “longer blog posts” you linked to don’t adequately describe your position like you have here – hence why I asked.

  8. Pingback: Tell the Secretary of HHS: Americans need continued access to affordable meds! | RxRights

  9. Hi Skeptek –

    Glad you’re trying to keep the debate “real.”

    UNAPPROVED DRUGS: Prescription drugs manufactured, packaged and
    labeled for sale in Canadian or other foreign pharmacies generally will not comply perfectly with FDA regulations and are, therefore, generally considered unapproved drugs. Those “unapproved” drugs, IF APPROVED in the country from which they are dispensed will often be the same medication sold in the U.S. in terms of safety and efficacy.

    MISBRSNDED DRUGS: Foreign prescription drugs where the
    actual capsule, tablet, inhaler, patch, or other formulation is identical to
    those sold in U.S. pharmacies are often considered misbranded drugs because the drugs are labelled and packaged differently than in the U.S.

    Therefore, safe and effective medication sold in Canada and many other
    countries are considered unapproved and/or misbranded by the FDA. The
    designation of “unapproved” and “misbranded” does not make those medications any less real or safe – or needed by the person who ordered, and is waiting for them. If they don’t get those real medications, and don’t take them, then they may get sick and die.

    Section 708 makes no distinction about safety in terms of which drugs FDA will destroy. Its destruction authority thus seems arbitrary and capricious, at least as it concerns the public health. If FDA finds a drug that is counterfeit or adulterated then by all means it should seize and destroy it.

  10. Thanks for your support, comments, and suggestions. We’ll take them into consideration when crafting further emails and posts. It’s a complex issue that is difficult to boil down for emails and blog posts. But we’re always happy to engage with people who have questions.

    We are talking about authentic prescription drugs bought from legitimate international online pharmacies with a doctor’s prescription. Often these are maintenance medications for chronic conditions such as asthma, heart disease, hypertension, etc… You can visit our website to see hundreds of testimonials from people who depend on importation to access medicine at prices they can afford.

    See Gabriel Levitt’s response above for some more specifics.

  11. Thanks to you and RxRights for taking the time to spell all that out. I agree that it’s a complex topic to summarize, but you’ve done a fine job here.

    I agree that the authority to destroy meds on those grounds is nonsensical, and I can’t help but wonder what arguments in favor of Section 708 could possibly amount to – if there are any. I need to educate myself further.

  12. Thank you for addressing my questions so directly – that was refreshing. I can see your dilemma in communicating this to a modern audience – there’s a nuance to it. However, you could start by fixing the formatting errors on your FAQ page (accordion/spoiler tags,etc.), adding links to the data and documents that support the cause, and perhaps even adding Gabriel’s summary to it.

    As for the specifics, I require no more convincing, but I’d still like to see actual examples of particular drugs by name. Also, and I mean no offense to anyone, testimonials are most commonly useless distractions, and sometimes even harmful to objective understanding of an issue, so I don’t have the motivation to wade through them.

    No matter – I feel better about supporting RxRights now, thanks to you.

  13. Please indulge me and forgive my ignorance, but here’s what I learned today:
    1. Section 708 of the FDASIA (the law that passed) only grants authority to destroy drugs that are already prohibited under Section 801 of the FD&C Act (a good law).
    2. Section 801 of FD&C Act only prohibits drugs that are:
    A. Manufactured, processed, or packed under insanitary conditions.
    B. Forbidden in the country produced or from which it was exported.
    C. Adulterated (Section 501 of the FD&C Act)
    D. Misbranded (Section 502 of the FD&C Act)
    E. Unapproved new drugs (Section 505 of the FD&C Act).
    F. Prohibited under Section 301 of the FD&C Act (interstate commerce).

    Gabriel mentioned “unapproved” in your objections, but do you really oppose the prohibition of new drugs before they’re approved (E. above)? I don’t remember you saying that. If so, then I may need to change my support position depending on your specific objections, because I’m of the opinion that new drugs should be approved before they’re allowed into the country. Regardless, isn’t it the FD&C Act at issue, not the FDASIA?

    As for “misbranded” drugs, that leaves us with Section 502 of the FD&C Act as the root of the problem.

    I read here that “Section 708 [of the FDASIA] changes prescription drug importation as we know it.” But isn’t it actually the FD&C Act that allows these drugs to be prohibited in the first place? I guess what I mean is, isn’t that your actual issue – that the FD&C Act somehow allows prohibition of “legitimate” drugs? Wouldn’t the proposed rules in the FDASIA make complete sense if good drugs weren’t getting caught up by whatever prohibits them in FD&C Act?

    Am I wrong about this all this?

  14. Glad to hear you feel better about supporting us! Thanks for the heads up about the FAQ page. We recently updated our WordPress plugins and didn’t realize that created a formating problem on that page.

  15. No, you’re not all wrong and you make good points. When you think of a drug that is “unapproved” what comes to mind?

  16. I have found that a lot of imported drugs have the same manufacturer that the U.S. has. As far as I know, the U.S. could be getting their medications from the same facilities. If people are unable to buy affordable drugs by getting them from other countries, I’m sure there will be a lot of people who won’t be able to get their drugs at all because of pricing. It hurts the individual but would also put a minuscule dent in Big Pharma’s profits because the individuals wouldn’t be able to order their drugs from the U.S. because the cost would be too exorbitant.

  17. I was gratified to see rmiers1 quote Colchacine as one of the drugs that would be destroyed. The greed-driven way that USPharma got the FDA to give them an exclusive right to market Colchrys and forced the rest (23 U.S. manufacturers) out of the business of making this drug, caused the price for the identical product to go from $.09 per pill to a worldwide price of $.45 and a US price of $5.00 per pill. (competition is wonderful) This effective gout treatment is a lifeline for many people.

  18. Pingback: A handful of senators stand up for affordable medicine | RxRights

  19. Are they trying to destroy VIPPS certified drugs? There are a lot of dangerous counterfeits that look exactly like the real drugs. The drug lords have found a way to make more money selling counterfeits, that actually are made with street paint, and chalk. All they need to do is have Canada in their website, and people will purchase it. We need to be extremely careful.

    If they are trying to destroy VIPPS CERTIFIED drugs, this is horrible! We can’t afford our medications! Most of these authentic drugs are made here, in the U.S., then sold in Canada and other countries at a much lower cost. Most of these drugs are necessary for our survival. How can they be so insensitive?

  20. Yes, it is importation to take care when ordering online. But if drugs are imported or reimported from abroad–even from legitimate international online
    pharmacies–they are not VIPPS certified. This is because VIPPS only
    certifies US-based pharmacies.

    And US-based pharmacies can’t offer the same dramatic savings as
    international pharmacies (since other countries control drug prices but
    the US does not).

    However, there are several groups that work to
    verify the safety of international online pharmacies. Some are members
    of our coalition. We have more information on our website about this
    issue:

    http://www.rxrights.org/nabp-report-lumps-real-and-rogue-pharmacies-together/

    http://www.rxrights.org/tips-for-choosing-a-safe-online-pharmacy/

  21. Big Pharma is inexcusably greedy, it charges exorbitant prices simply because it can. I will grant it costs money to research and develop medication, but when you compare the prices for those same drugs produced in other countries the marked contrast with U.S. prices is inescapable. It would be a travesty if the Big Pharma lobby were able to use it’s very deep pockets to usurp the rights of Americans to shop wherever they find the most competitive prices. They have no right to dictate to the American public where they buy their medication. Do not allow this self-serving piece of legislation to pass. It would be the final nail in the coffin for financially strapped citizens and it would, quite literally, make Big Pharma a total monopoly. This is transparent corruption of the democratic process where one can easily see this piece of legislation is at the behest of Big Pharma to increase it’s already obscene profits, and benefits consumers not one whit. For shame!

  22. I suggest the government concentrate on illegal drug trafficking and leave this issue to the honest, hard working and financially challenged people of America who WISH they had the luxury of prescription drug coverage!

  23. Canada is safe or safer than US. Same drug companies wanting to ban Mexican pharma actually manufacture the drug in Mexico.
    Some drug companies only seek more profits. Satan loves excess profit especially when harm and pain is involved.

  24. WE SHOULD HAVE OWN OWN GREAT MEDS MADE HERE!!! AND ONLY WE THE PEOPLE SHOULD BE ALLOWED TO BUY OUTSIDE AND “NOT THE PHARM” BECAUSE IT PROTECTS OUR RIGHTS AND IT WOULD FORCE THE DRUG COMPANIES TO DO THE RIGHT THING AND MAKE GREAT PILLS OR WE WILL GO ELSE WHERE.

  25. I am outraged that the FDA is now
    seizing and destroying legal and USA prescribed, non USA pharma drugs
    that come to the USA to US Citizens!!!! The FDA told me today that
    CONGRESS is pushing the FDA to do this, to destroy personal use drugs
    legally purchased from non USA sources with a USA doctor
    prescription. THIS IS OUTRAGEOUS and MUST STOP. I am contacting AARP
    and advising them of this push. The old people are being abused int
    his way. For example, with donut holes and all in medicare, Celebrex
    is $5 a capsule, and I can get it from Canada in generic form for 32
    CENTS. WTF???? STOP THIS FDA and CONGRESS mandated tyranny. My drugs were seized [celecoxib] that I need for chronic and sever back pain INSTEAD of opiates.!!! They have been sent BACK or DESTROYED> and I appealed to the FDA as notified… NO DICE, still “illegal” and they blame congress forcing them to do this.

  26. You’re right Larry, it is totally outrageous. You spoke to someone from the FDA? We’d love to hear more about their response.

    We’re glad to hear of your efforts to contact AARP. They haven’t fully come out to support importation as a key issue, but they should.

    Can you tell us more about your drugs that were seized? Was this recently? We are trying to establish whether these confiscations are isolated incidents or not. Thanks for your comments and support!

  27. Thank you for contacting AARP. We’d recommend contacting your legislators and writing a letter to your local newspaper too. With your help, we can raise the profile of this issue. When were your medications confiscated? We’d like to learn more about this so that we can determine the best way to fight it.

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