Cities And Counties Unlikely To Heed FDA Warning On Importing Foreign Drugs

Yves here. I found this article more than a bit frustrating, in that it didn’t clarify the legal and medical issues regarding ordering drugs from foreign suppliers. I’m not sure whether this is due to the author being too close to the subject matter or a Kaiser Health News editorial stance of not getting very much into the weeds.

One matter it glosses over is the relationships among the patient, the physician providing the Rx, and the pharmacy. There is a legitimate concern with foreign online pharmacies in that some (many?) will authorize a drug prescription using an affiliated doctor when the doctor has made no exam of the patient, no review of records, and typically is simply authorizing a patient request. Having patients self prescribe is not a hot idea. The question then becomes what if any legitimate means there are for US patients to have their medical conditions validated by a non-US doctor if the foreign doctor has never examined the US patient.

A second matter is that the US has made it illegal to re-import drugs. This is a clear sop to the pharmaceutical industry, but is nevertheless a bar to ordering from Canada, since most of the drugs are likely to be of US origin.

A third, which the article alludes to, is whether the foreign pharmacy is selling bona fide drugs. There have already been scandals in the US drug distribution network with drugs getting into supply that were repackaged to hide the fact that they were past their sell-by date or to show a higher potency. If a foreign pharmacy is so outside the law that it has captive MDs writing scrips for whatever the patient wants, why should anyone expect the drugs to be any good?

I say this as someone who regularly gets a prescription medication from Australia. But I deal with a doctor who has examined me and get it shipped from one of the big drug store chains. But it goes without saying that Americans go to these lengths only because drug companies are allowed to charge what the market will bear, which is not surprisingly quite a lot, while in every other advanced economy, governments bargain hard for better prices.

By Phil Galewitz, Senior Correspondent for Kaiser Health News, who has covered the health beat for more than two decades. He is a former board member of the Association of Health Care Journalists. In 2004/05, he was a Kaiser Media Fellow and wrote about community solutions to the uninsured. Before coming to KHN, he was at The Palm Beach Post and was a national health industry writer for the Associated Press. Originally published at Kaiser Health News

Cities and local governments in several states said they will continue to use a Canadian company to offer employees prescription drugs at a highly reduced price, even though federal officials raised safety concerns about the practice last week.

The municipalities use CanaRx, which connects their employees with brick-and-mortar pharmacies in Canada, Great Britain and Australia to fill prescriptions.

In a letter Thursday to CanaRx, the Food and Drug Administration said the company has sent “unapproved” and “misbranded” drugs to U.S. consumers, jeopardizing their safety.

The FDA urged consumers not to use any medicines from CanaRx, which works with about 500 cities, counties, school districts and private employers to arrange drug purchases. Some of these employers have used the service as far back as 2004.

Prices of drugs from overseas pharmacies can be as much as 70 percent lower than what people pay in the U.S. because the costs are regulated by the foreign governments.

FDA officials would not explain why they waited more than a decade to act. They acknowledged the agency had no reports of anyone harmed by drugs received through CanaRx.

The FDA made its warning as Congress and the Trump administration look into ways to lower drug prices. Last month, Florida Republican Gov. Ron DeSantis said he has President Donald Trump’s backing to start a programto begin importing drugs from Canada for state residents.

After DeSantis’ comments, White House officials stressed that any such plan must get state and federal approvals.

The FDA said that in most cases importing drugs for personal use is illegal, although it very rarely has tried to stop Americans from bringing drugs across the Canadian border. It has not stopped retail stores in Florida that help consumers buy drugs from Canada since 2003. Nine storefronts were raided by FDA officials in 2017, although the FDA has allowed them to continue operating.

Schenectady County in New York, which has worked with CanaRx since 2004, defended its relationship and had no immediate plans to end it, according to Chris Gardner, the county attorney. “We will wait to see how this plays out, but right now it’s status quo,” Gardner said.

He said CanaRx, which is headquartered in Windsor, Ontario, helped the county save $500,000 on drug costs in 2018. About 25 percent of the county’s 1,200 workers use the program and get their drugs with no out-of-pocket costs. If they use American pharmacies, they generally have a copayment.

“This is a good program, and on the merits it looks lawful, and they are not doing the terrible things that the FDA is suggesting,” Gardner said.

CanaRx officials denied they were breaking any laws or putting Americans’ health at risk. They say they are not an online pharmacy but a broker between brick-and-mortar pharmacies in Canada, Australia and Great Britain and U.S. employees. People can buy drugs via CanaRx only with a prescription from their doctor.

The company said it has no plans to stop distributing drugs.

“The FDA’s characterizations of the CanaRx business model and operating protocols are completely wrong,” said Joseph Morris, a Chicago-based lawyer for the company. “It is not possible to place an order via any CanaRx website; the websites are informational only.”

Morris said the FDA notice prompted calls from many municipalities but all so far say they plan to stick with the company.

Columbia County, N.Y., has been using CanaRx for about a decade and the savings allows it to offer employees drugs with no out-of-pocket costs instead of paying up to a $40 copay in local pharmacies.

“This is bull,” Stephen Acciani, an insurance broker who works with the county, said of the FDA crackdown. “They are not selling unsafe medications.” His recommendation would be for the county, which has more than 600 employees on its health plan, to continue using CanaRx.

He noted that employees receive drugs through the mail in their original packaging from manufacturers.

Kate Sharry, a benefits consultant to the city of Fall River, Mass., and more than 100 other municipalities in Massachusetts, said, “It will give some clients pause. How can you not pay attention to this from the FDA?” But she expects the local governments to stay with CanaRx.

Federal health officials under both Republican and Democratic administrations have blocked efforts to legalize importing drugs, saying it’s too risky.

“Sometimes a bargain is too expensive,” said Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, a New York-based nonprofit that receives some of its funding from drugmakers.

Pitts, who applauded the FDA action, said it’s difficult for consumers to know when their pills from foreign pharmacies don’t have the correct potency or ingredients. He said doctors may also not realize a patient’s problem stems from issues with the medicine. Instead, the physicians may just change the medication’s dosages. He said it is not safe for Americans to buy drugs that are imported through foreign pharmacies.

Gabriel Levitt, president of PharmacyChecker.com, a website for U.S. consumers that verifies international pharmacies offering drugs online, said CanaRx is one of the safest ways for Americans to get drugs from legitimate pharmacies in Canada and other industrialized counties.

He said the FDA is trying to intimidate CanaRx and its local government clients. “My biggest fear is they will scare consumers and they won’t take their very safe and effective medications because they hear about this bogus warning.”

“The FDA’s action, which appears to try and make those programs look unsafe and sinister, seem to have a political and public relations purpose, one that is perfectly allied with the lobbying agenda of drug companies,” he said.

He pointed to testimony by FDA Commissioner Scott Gottlieb last week — just a day before the CanaRx warning. When asked about importing Canadian drugs, Gottlieb did not mention CanaRx, but he said that people going to a “brick and mortar” pharmacy in Canada “are getting a safe and effective drug. I have confidence in the Canadian drug regulatory system.” He added that his concerns are with online pharmacies.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the industry trade and lobbying group, cheered the FDA action but denied it had any role in it, said spokeswoman Nicole Longo.

“PhRMA supports the FDA’s efforts to crack down on organizations that are circumventing its robust safety and efficacy requirements,” she said. “Drug importation schemes expose Americans to potentially unsafe, counterfeit or adulterated medicines.”

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29 comments

  1. polecat

    Will someone explain to me WHY we even HAVE and FDA anymore .. if this is how they protect their charges, who seem to Not be the public ??
    It’s no wonder that the public has shown increasing mistrust of our governmental institutions.

    Reply
    1. pretzelattack

      in some order
      1.to advance the interests of the industries they regulate
      2.to serve as a springboard for jobs in those industries
      3.to protect the interests of the public
      4.to maintain a facade of protecting the interests of the public

      imo.

      Reply
      1. Carla

        Basically a good list and priority order, but I think it would be more accurate if we just eliminated #3.

        Reply
        1. pretzelattack

          that may be; in order to accomplish 1 and 2 they have to maintain the facade, and in order to do that, they actually have to protect the public interest to some extent. i’m thinking there are some people that still work there that are actually interested in 3, but maybe i’m too idealistic. neoliberalism and corruption are hollowing out our institutions.

          Reply
          1. JBird4049

            I think plenty of people at the FDA want to do their job of protecting the health of Americans, but since the leadership are political appointees wanting to do #1 and #2 those doing #3 are shut down whenever they hinder the money.

            Reply
            1. pretzelattack

              i was thinking of the pushback and work people studying climate were still able to do despite that work being altered and opposed by their bosses at nasa and the epa; the latest example i’m aware of being the effort to preserve the information and data the trump administration tried to hide or dump–to do this they had to put their jobs at risk, as james hansen had to do under earlier administations. the friction of resistance by the rank and file trying to do their jobs , to the agendas of the political appointees, probably varies by the agency.

              Reply
  2. Mike G

    Can’t remember the name at this time of night, but the better Canadian pharmacies adhere to a code of conduct as strict as any in the US as far as prescriptions.
    If the US was serious about safety of importation, it would be easy to adopt such a code and allow importation only from pharmacies adopting the code. Competition would force them all to adopt it.

    Reply
    1. Yves Smith Post author

      As I indicated in my intro, it’s not just a matter of the pharmacies. It’s a matter of the doctors issuing the prescriptions. Please tell me how many US citizens who order drugs from a Canadian pharmacy have a legitimate prescription from a Canadian doctor, as in the doctor has examined them determined they have a condition that warrants them getting that medication, and is in a position to monitor their use. For starters, imagine how many people would (or even do) order human growth hormone, which a lot of “anti-aging” doctors in the US prescribe? It’s already a dodgy practice due to this practice being suspected of increasing the odds of getting cancer, but it would take large scale record keeping to determine that, and the MDs have no interest in finding that out.

      Reply
      1. Carla

        I regularly fill one prescription online with Canada Pharmacy. They require a prescription from my regular doctor which my doctor’s office faxes to them. It costs less than a third of what I would have to pay for it here.

        Reply
        1. BrooklinBridge

          The Canadian Pharmacy accepts prescriptions from US doctors? Do you know if that is generally true in Canada (and other countries)?

          Reply
      2. Anders K

        While this is an important part of the puzzle to make sure patients get the right medications, it doesn’t seem like it’s the one the FDA (in this case at least) is actually worrying about. If the quality of the medication is the issue, I doubt that Canadian pharmacies should be the first in line to examined (I was also amused by the bundling of Canada together with other pharmacies as being “overseas” ). If, however, protecting the US Pharma industry is the concern, of course this would be a first stop due to convenience and the perceived (not sure about real) safety of ordering from them.

        If getting the right medication is that important, and if one wishes make sure patients meet with a doctor in the flesh first, it should not be that hard to get Canada to join in on a system which would provide digital prescriptions from said doctors (and not allow for substitutions if one is worried about drug interactions). It would cost quite a bit of money, but it should be worth it for getting it right – and it will probably even get approval from the doctors.
        I just doubt that it is the medication safety that is the goal of this exercize.

        As an aside, in Sweden we have started to get access to doctors by video-call and they can prescribe medications based on that. It’s not the first step towards crapification of the “medical experience” – but at the same time I can see the benefit for low-impact, occasional illnesses (why do you have to get to a primary care center, wait in line for hours only to get non-dangerous drug X prescribed) but I can see how the slippery slope to only privately insured people or the deathly ill having physical access to doctors.

        Reply
  3. The Rev Kev

    A lot of concern is raised in this article about bringing in pharmaceuticals from overseas but through the wonders of globalization, it is not so simple anymore determining a place of origin. I have just read that about 40% of drugs consumed in the US are manufactured overseas, mostly coming from China and India. Even if you decide to only take drugs manufactured in the US, about 80% of the ingredients also come from overseas so no luck there either. There is a bit more on this topic at https://www.latimes.com/business/lazarus/la-fi-lazarus-drugs-country-of-origin-20180515-story.html
    I would immediately dismiss the FDA’s concerns about these drugs as this is the same agency that allowed opioid painkillers to proliferate and fuel an epidemic of addiction and overdose under its watch. The long and the short of it is that there is something seriously wrong with a system where it is cheaper to bring in drugs from 10,000 miles away than from the drug store down the street. As for the situation where doctors cannot properly supervise patient’s drug use, perhaps as a stopgap solution you could have consultations by Skype in some center and where the doctor has access to the patient’s medical records. It may not be a great system but may be better than none.

    Reply
    1. Phacops

      And, don’t forget about past FDA guidance that promoted drug substance adulteration by Chinese manufacturers.

      Prior to 2008 the FDA issued guidance on receiving and using drug substance (active ingredient) from suppliers. A manufacturer was allowed to accept and use drug substance using the certificate of analysis along with a test for strength and identity after they received three lots that met all specifications. So, there was deliberate adulteration of Heparin drug substance by Chinese manufacturers. Sulfonated junk protein which met strength and simple identity testing was substituted for heparin and used by final drug manufacturers. This ended up killing about 80 people and injured near a thousand. The response by Chinese authorities was that they have no interest in regulating drug substance being exported. Caveat emptor, indeed.

      I had an interesting time reading journals with a translator . . . Some ads were for setting up potemkin drug manufacturing facilities to obtain a facility license from the FDA after which manufacturing was sent to often substandard facilities.

      Don’t get me started on India where falsification of manufacturing and testing records is a way of life. The FDA even allows drugs where testing was fabricated to be sold by pharmacies after they had issued embargos.

      Far more ignorant about drug quality issues by manufacturers are the pharmacists who fill your script.

      Reply
  4. Phacops

    Meanwhile, drugs, devices and bulk drug substance from India and China are distributed by pharmacies in the US despite a history of adulteration by manufacturers from those countries. All with the FDA’s approval.

    Having been through facility inspections by Canada’s HPB I’d trust their regulatory process. Compared to the FDA it seemed to me that the HPB was not as adversarial, pushed for concrete solutions for issues they observed, and were far more interested in applying quality engineering to pharma manufacturing than the FDA.

    Reply
  5. Steve Ruis

    Yeah, right. My asthma medicine, made under patent, I get from Canada and is “made” in Ireland. I get twice as much medicine for one third of the price. And I am supposed to show loyalty to American sources?
    My Canadian pharmacy requires a prescription, which they confirm with my doctor via telephone. How is this wrong? Oh, because American Pharma says so, through their bought and paid for politicians.

    Reply
  6. Lee

    We’re already getting some cheap medications from other countries. Most notably in the news of late have been widely prescribed generic blood pressure medications manufactured in India and China tainted with carcinogens, which your family doctor will prescribe and which you can pick up at your local pharmacy. No new legislation needed for this particular poison pipeline.

    Reply
      1. Lee

        I just started taking amlodopine besylate. I’ve previously had adverse reactions to three other blood pressure meds I’ve taken. Two of them were on the FDA recall list. Fingers crossed.

        Reply
      2. Phacops

        Notice in the discussion to use test methods to characterize nitrosoamines in product, there is a backhand warning to manufacturers not to change the manufacturing process without proper validation.

        In reality this can be a severe infraction of good manufacturing process and indicate to an inspector that there are facility-wide deficiencies in process control. Wonder if this has triggered a quality systems inspection by the Agency?

        Reply
    1. Skk

      Costco pharmacy showed it’s mettle to me, when the ranbaxy scandal over generic lipitor blew up, I asked them not to give me a ranbaxy generic. They said o we stopped using them 15 months ago

      Reply
    2. Phacops

      Carcinogens or other potent impurities showing up in drug substance points to a manufacturer unilaterally changing the manufacturing process without exhaustively revising tests of their impurity profile. That is something that cannot be done under good manufacturing practice without undergoing process validation including characterization of all impurities (not lumping them under the heading of NMT x% of all other impurities) and a submittal for approval to regulators before implementation of the change.

      That is basic to drug manufacturing and the adulteration with impurities not before present in the materiat speaks directly to the general regulatory environment for all drug and device manufacturing in the country of origin.

      Remember the contaminated tryptophan produced by Showa Denko when they made an organism substitution in their fermentation in 1989? That production change resulted in permanent injury to 1,500 supplement users and over 30 deaths.

      Interesting how when we lose the facility in manufacturing expertise, quality engineering, and proper regulatory oversight, people are ignorant of risk.

      Reply
  7. Skip Intro

    The real tragedy is that this blatantly corrupt scaremongering undermines the credibility of the FDA and other regulatory organs, and leads to things like measles epidemics. Can anyone here honestly claim that most published research results in the medical/pharmacological sciences are really reproducible, objective, and unbiased? The results of systematic corruption that leads to widespread loss of trust can be seen in areas as disparate as toxic securities and pedophile priests.

    Reply
  8. mauisurfer

    My prescription for ventolin/asmol inhaler was costing $47 to have filled at my HMO,
    and that is with “advantage” health plan and medicare.
    Cost even higher at Costco.
    Got my doc to write prescription, sent it to canada, now my inhalers come from Singapore
    for $4 each.

    Reply
    1. Phacops

      Not manufactured in Singapore. I’d bet on one of the facilities run by Chinese on Batam, across the strait. Manufacturing is done by Indonesian girls sent to compounds there from their villages who get paid next to nothing.

      I’d have an ethical problem supporting such abusive conditions, even at a $43 savings. It’s just plain ugly.

      Reply
  9. baldski

    The US imported $108 billion in pharmaceuticals last year. Does this mean drug companies are off-shoring production to low cost countries? They can import drugs, but you can’t. What is wrong with this picture?

    Reply

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