Every day, countless people across America order prescription drugs from pharmacies in other countries as they hunt for something increasingly elusive — affordable medications.

But there’s a problem. Under most circumstances, importing medicines is illegal.

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  • It is frustrating to see this tired “solution” being peddled over and over again, despite multiple expert responses indicating that such a law would guarantee that Americans would be exposed to a flood of counterfeit medications, which at best would be ineffective and at worse cause illness and even death. The last 5 FDA Commissioners in a row, including Scott Gottlieb, all have opposed this shortsighted idea, with good reason, yet this article hand waves past the issues by noting a few of them and then blithely postulating that they can easily be dealt with, but without actually offering practical ways of doing so. Incidentally, this article neglected to note that a key source of counterfeit drugs is terrorist groups–Hezbollah has a major factory in the Middle East that helps to fund its operations. It’s estimated that perhaps 30-40% of the medications used in India, Turkey, China and other parts of the world are counterfeit. Online Canadian pharmacies also obtain drugs from these sources. There is no credible way to prevent this, especially since Canada’s population is 10% that of the US and Canada would not be able to supply the US with legitimate drugs to any great degree, but would have to rely on external sources. The example given in this article to the effect that active pharmaceutical ingredients are sourced ex-US is specious, as those suppliers are carefully vetted and monitored by legitimate biopharma companies, and subject to FDA and other regulatory inspections. It is unlikely that Hezbollah or Russian criminal organizations would allow the same.
    Beyond the infeasibility of this idea is the fallacious principle that underlies it: that we should be importing other countries’ lower drug prices here. It is indeed unfortunate that the rest of the world declines to pay its fair share of the cost of biopharmaceutical innovation. However, the solution should be to find ways of distributing these costs more equitably, not to undermine the last bastion of biopharma innovation, which produces almost 60% of all new drugs (i.e. almost 50% more than the rest of the world combined).
    One might also ask why it is that drugs, which comprise about 14% of healthcare costs, are the lone object of attention in editorials such as this one. All medical costs are much less in other countries than in the US, and drugs do not stand out as unusually more expensive on a relative basis. In fact, many surgical procedures in the EU cost less on a relative basis–up to 20% or less the US cost. Perhaps we ought to consider importing EU and Canadian surgical teams, as well?

    • Mr. Cohen throws out a lot of numbers about counterfeit drugs that I know are not defensible. But his rant is quite indicative of the Orwellian approach of the drug companies to talking about counterfeit drugs and online pharmacies.

      — Importation was referred to as a tired solution. Mr. Silverman’s point is that it’s already a solution. Millions of Americans import medication for personal use. For many it’s a lifeline of affordable medication. Here’s a source: http://khn.org/news/faced-with-unaffordable-drug-prices-tens-of-millions-buy-medicine-outside-u-s/

      — FDA commissioners, including Scott Gottlieb, oppose it. That’s true. But FDA Commissioner Gottlieb’s colleague at American Enterprise Institute, Roger Bate, an expert on counterfeit drugs, supports personal importation. Unlike Gottlieb or the FDA, Mr. Bate has done peer-reviewed, empirical research on online pharmacies and importation and the results are nothing what you’d ever imagine. Source: http://safemedicinescoalition.org/resources/The-risks-and-benefits-of-the-Online-Pharmacy-Market.pdf.

      — Terrorist groups are a key source of counterfeit drugs, particularly Hezbollah. Importing lawfully-manufactured medications from Canada and other countries is one thing. Terrorist manufacturing counterfeit drugs is another. Pointing out that Hezbollah is involved in this trade is scary but simply doesn’t present an argument against Americans importing lower cost medication from Canada.

      — Cohen writes: “It’s estimated that perhaps 30-40% of the medications used in India, Turkey, China and other parts of the world are counterfeit.” It’s also estimated that less than 1% of drugs used in India are counterfeit. Saying “It’s” estimated does nothing to argue a point. There are a lot of fake “facts” on this topic that don’t work to the advantage of the drug companies.

      — Mr. Silverman’s point that many APIs and medications sold in the U.S are already imported is called “species” by Mr. Cohen because he attests that those ingredients are carefully vetted by FDA. They might be but FDA may know very little about API sourcing. Here are some facts with sources to show that. In a 1998 GAO report the authors note that FDA find that 80% of the APIs in U.S. medications are imported. Fast forward to 2011 when FDA became focused on the so called huge growth in global pharmaceutical manufacturing because, now, 80% of APIs are imported. The thing is that FDA’s own data shows zero growth between at least 1998-present. Is importation of APIs growing or not? Does the FDA really know?
      GAO 1998: http://www.gao.gov/products/GAO/HEHS-98-21. P. 1.
      FDA 2015: https://blogs.fda.gov/fdavoice/index.php/tag/pharmaceutical-quality/.

      My belief is that until recently FDA did not (and perhaps could not) reliably know the penetration of lawful importation in terms of % of sales in the U.S. Improvements in data management, better funding for inspections, and just the will to get it under control are real and FDA is more strongly living up to its mission.

      The rest of Mr. Cohen’s comments are about saving pharma R&D, noting that medications are only 14% of healthcare costs, and healthcare costs are lower in all areas in Canada and the EU. The last two points aren’t arguments against importation so not sure why they are here.

      The R&D cost claims from the drug companies are highly exaggerated (here’s a good summary from 2009: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2630351/).

      I believe that pharma R&D is expensive but it’s still NOT a valid argument against importation of lower cost medication, especially personal importation. If you can’t afford a medication (tens of millions of people can’t), biotech research costs are NOT YOUR PROBLEM. Getting affordable medication for you and your family is the only important focus. Sometimes importation is the answer.

    • Mr. Levitt’s reply begins by characterizing my original note as a “rant” and “Orwellian.” This is unfortunate as, in my experience, resort to name calling is generally reflective of an emotionally held position, rather than one founded on fact or reason. That said, here are some references to consider:
      http://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=1022&context=jil
      http://www.whpa.org/background_medicines_counterfeiting_in_africa_chioma_jo_onwuka11-2010.pdf (especially pages 12-19)
      http://www.aarp.org/health/drugs-supplements/info-2016/counterfeit-prescription-drugs-rx.html
      http://www.bbc.com/news/business-37470667
      “Fake drugs constitute 25% of domestic medicines market in India: ASSOCHAM”. Retrieved 2017-06-05.
      http://www.downtoearth.org.in/news/fake-drugs-constitute-25-of-domestic-medicines-market-in-india-assocham-45393

      These amply detail the scope of the problem of counterfeit and substandard medicines (at the cost of scores of thousands of lives a year for malaria alone). To posit, as Mr. Levitt essentially does, that this is a problem for developing countries, conceding that it supports terrorism, “but after all what can be the harm in letting a developed country like Canada export drugs to the US,” is to ignore the multiple authorities, including those at FDA, and within Canadian regulatory and governmental agencies, all of whom agree that allowing drug reimportation to the US and Canada would invite a tsunami of illegal drugs to be funneled through Canadian shells, little of which could be regulated or effectively prevented. Bear in mind that Canada, at 10% of the US population, could only supply the US to any meaningful degree via massive imports of drugs from other countries, which it would not have the size, scope or funds to police effectively.
      This also begs the question of what really would be achieved, other than exposing Americans to harm–the answer is price controls by another name. The only reason that other countries are able to get away with exerting their own price controls on drugs is that the US remains the only market in the world where high-risk investments in drug development are rewarded substantially enough to encourage further investment. Remove that incentive and we won’t have to worry about disparities in pricing–twenty years from now we’ll all be using today’s drugs at tomorrow’s (generic) prices, but without access to tomorrow’s drugs.
      The paper that Mr. Levitt adduces to counter arguments about the costs of drug development in fact is attempting to counter an argument that is itself fallacious (one which admittedly the pharma industry put forth for years, and should not have): that the costs of a drug are directly related to the costs of its development. This is not the case. However, what is very much the case is that investment capital is fungible–it doesn’t care if it is directed to a new therapy for Alzheimer’s or a new capability for Amazon’s Alexa. But to invest in the Alzheimer’s therapy is to recognize that ~98% of all Alzheimer’s trials have failed, that the average time for any drug to be developed successfully is 10-15 years, that 90% of all drugs that reach Phase 1 clinical trials ultimately fail and that 90% of all biopharma companies today are not profitable. The cost in question then is not that for an individual drug, but for supporting the entire risk-taking ecosystem that must pay for the 90% of failures in order to realize a return on the 10% of successes. The biopharma industry invests about $150 billion/year in R&D (https://www.bio.org/sites/default/files/BIO_RD_one%20pager%205-9-17.pdf) about 5x the budget of the NIH. High prices for new branded drugs are necessary to support drug innovation. It’s critical in this regard to acknowledge that these high prices don’t last forever. On average, new drugs lose exclusivity within ~10-12 years and are available cheaply as generics forever after. About 90% of all US prescriptions today are for generics. It is this that provides the financial “headroom” to pay for biopharmaceutical innovation. That is a great deal for American society. The challenges have been that the system has not always worked efficiently, with various games being played around exclusivity periods (and on the other side, unfortunate undermining of intellectual property rites by misguided policies). A rational system would create more certain and dependable exclusivity periods, and in return assure even more rapid and reliable generic and biosimilar entries when exclusivity periods legitimately expire.

    • I apologize to Mr. Cohen for calling his comment a “rant”. He’s right that that’s wrong. However, I stick to the notion that the argument’s he’s making about safety are “indicative of the Orwellian approach of the drug companies to talking about counterfeit drugs and online pharmacies.” I respect that he is assessing properly things he’s reading in the news and even academic literature — but there’s a lot within those sources that are plucked from thin air. That’s what makes it Orwellian. I’ll bring more back to this discussion soon but you should read Bate’s full paper here: http://safemedicinescoalition.org/resources/The-risks-and-benefits-of-the-Online-Pharmacy-Market.pdf.

  • We should all petition our representatives to reject these Draconian Legislative attempts to curtail our right to relieve our pain &suffering.
    A senior arthritic & cancer survivor.

  • The only sure way to prevent counterfeit drugs from entering the supply chain is for the FDA to mandate Radio Frequency Identification (RFID) tags for all legit drugs at all points along the supply chain so that every bottle can be tracked back to its original source. However there is no mandate, only “encouragement” from this FDA document.

    https://www.fda.gov/Drugs/DrugSafety/ucm169918.htm

  • A medicine I used to take given by my Dr. who worked in orphan diseases, is made in Calif. but not sold in the USA. I had to go underground or have someone buy it overseas. I can’t get it anymore but it is sold out of the country. Why???

  • It almost always comes down to economics. As long as foreign lobbyists have access to our corrupt politicians and can bribe them, Congress may be willing to allow competition. If no effort is to be made to consider the interests of our officials, nothing will be accomplished.

  • Are we talking about a Country where we find “regulated” lead containing water, inadequate public schools, banks involved in red lining and hosts of other intentional offenses? The garbling of the FDA assumes that their public ignorance and greed matches that of their board and their other shills. It is well documented that increasing longevity of recent decades is related more to ameliorating the rapid progress of tertiary illnesses than to prevention and primary treatment. Access to appropriate therapies is limited to those who have the means to pay prime rates. Our elected Reps seem to be thinking that “poor and sick/dead” is as acceptable as an earlier administration’s mantra of “collateral damage”, referring to civilian mortality from weapons of death. This huckstering of medications is a top down issue bent on compromising the political base.

  • To summarize, it is cheaper for Americans to buy drugs that are shipped to another country first before they are shipped to the US. Could part of the problem also be that that here in the US, there too many middle men in between a medically necessary drug and the patient? Can’t imagine that the middle men would go along with drug importation unless they don’t lose any business and also get a portion of the savings.

  • Bingo. You’re exactly right. Let me throw one more idea out there. Give the drug companies a break by accepting approvals from certain other countries. Countries like Canada, Japan, the EU, UK, etc. Any approved drug or device in those countries will be accepted here. Allow importation from these countries as well. That way drug companies can’t cut sweet heart deals with those countries and have the US foot the entire R&D bill. While the drug companies face price pressure, approvals may be less expensive, and more expansive

  • c’mon ed, you’re better than this.

    the reason why congress + pharma want to prohibit importation is because therapies cost less in many other countries. this is due to a variety of reasons (cost of living, payers’ bargaining power, etc).

    the risk of tainted formulations is a real but separate issue.

    if congress allowed importation, then pharma would simply raise prices in other countries, thereby obviating the driver of importation. your solution makes zero sense.

    • Hi Kerry,
      Thanks for the note. I agree with your point, although there’s a provision in the bill introduced by Sanders to try to obviate that scenario. Whether that can, in fact, be addressed as envisioned remains to be seen.
      All best,
      ed

    • Kerry – I’m not sure what you mean when you write “you’re better than this”. Ed Silverman brings objectivity to this, no?

      Yes, drug companies would push back on pricing if importation laws were reformed to allow importation of lower cost drugs, but there would be push back against that, too. How do you know where prices would land?

      Also, the article is more than an analysis of the proposed legislation. It informs readers that millions of Americans already import medication for personal use, illegally, and our “domestic” supply is already heavily reliant on importation. That being the case, let’s make importation work even better for affordability.

      Safety issues are real but the hyperbole funded by industry is Orwellian.

    • ed, thanks for your response.

      i haven’t read sanders’ bill, but not sure how congress could dictate how pharma prices its products outside the US.

      in my view, a better alternative to lower drug prices would be for congress to prohibit DTC advertising, which inexplicably is allowed in only 2 out of 196 countries worldwide (including the US, as you know).

    • Hi Kerry,
      There is a link to the bill in the column, so you can brush up at your leisure. As for DTC ads, I suspect that is another tough march uphill, especially since there will be some pretty stiff fights over commercial speech, not that it is impossible. If nothing else, it would be extremely interesting.
      Best
      ed

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