In this blog post I’m going to get personal. Not about me but about importing medication from Canada and other countries. You’ll see what I mean. Last week, Senator Bernie Sanders introduced an amendment to the budget bill, which would have paved the way for future deficit neutral spending to implement new regulations expanding lawful access to lower cost imported medication from wholesalers, pharmacies and individuals. Unfortunately, the amendment was defeated 52-46.
Let’s forget about the fact that drug companies give members of Congress lots of money. OK, I can’t forget: it’s about two billion dollars over the last 15 years. Some senators who voted against the amendment cited their concerns with safety as a basis for their vote. Let me explain why they are wrong, at least when it comes to personal vs. wholesale drug importation.
Senator Cory Booker (D-NJ), who says he supports importation as part of several actions needed to address high drug prices, voted against the amendment because of safety, saying:
“Any plan to allow the importation of prescription medications should also include consumer protections that ensure foreign drugs meet American safety standards.”
For starters, many foreign-made drugs do meet “Americans safety standards” and those medications are sold in U.S. pharmacies. Surprise! The importation of prescription medication is already allowed and, according to the FDA, 40% of the medications we buy in the U.S. are foreign made and 80% of the active pharmaceutical ingredients that make up “American medications” are foreign-made. The FDA argues that they have oversight over those foreign-made medications; and I agree with them, although its oversight – like those of all drug regulatory authorities is imperfect. But lack of FDA oversight does not mean that medications sold outside the U.S. are not entirely, equally as safe as those sold here.
More importantly, Americans already buy medication internationally, often by using the Internet for well over 15 years now, in technical violation of the law. They do it because they can’t afford it here or it’s just so much cheaper that it seems unjust to do otherwise. Occasionally the FDA snags a prescription order but people are not prosecuted for small imports of medication for personal use. Are they safe? If they buy from licensed pharmacies in many different countries then, yes, they are usually very safe.
The key to safety is consumer guidance toward safe international online pharmacies and away from rogue operators. Empirical data in peer-reviewed studies, led by people, such as Roger Bate, who are sometimes considered pro-pharma, demonstrate that IF consumers import medication that they have ordered from credentialed online pharmacies THEN they will obtain lawfully-manufactured, safe and effective mediation. In contrast, orders placed with rogue online pharmacies, usually ones that don’t require a prescription or hide their identities with no mailing address, have turned out to be fake or substandard medication.
But what are these credentialed online pharmacies? Well, PharmacyChecker.com is one of the credentialing agencies tested in the peer-reviewed studies. Our standards and verification program rules can be found here. While compliant online pharmacies in the PharmacyChecker Verification Program must meet many standards, the key to safety and consumer fairness is verifying the licenses of the pharmacies filling the orders, making sure the online pharmacies require a valid prescription and are transparent and honest in their pharmacy services.
In contrast to the personal drug importation described above, importation legislation considers wholesale importation: meaning pharmacies and wholesalers importing commercial quantities of medication for resale and dispensing in U.S. pharmacies, hospitals, clinics, and other licensed healthcare settings. Again, such importation already happens, lawfully. But in those instances, the distribution and therefore the pricing is controlled by the drug companies.
Case in point. Wellbutrin XL – the version sold in American pharmacies – is made in Canada [read the label]. The company licensed to sell that drug in the U.S. charges a higher wholesale price to U.S. commercial purchasers than Canadian commercial purchasers pay. Through regulatory reforms, such as the ones envisioned by Senator Sanders, CVS pharmacy could buy the lower cost Wellbutrin from a licensed wholesaler in Quebec, which ostensibly means they can charge PBMs and consumers much less – if they pass the savings on to the consumer.
Those regulatory reforms due pose new safety considerations because the FDA would be expected to provide the same guarantees over those newly permitted wholesale imports – and that costs money. It’s still a good idea and can be done right but it’s important to distinguish that from Americans buying medications for themselves from Canadian pharmacies.
Personal importation is when a consumer decides to trust a pharmacy in another country to send medication by mail. The consumer is putting his or her faith in the regulatory framework of the country from which the medication is sent. For the FDA to give its guarantee over those medications it would need to register pharmacies, which is something it could do. Keep in mind, the FDA doesn’t license pharmacies in the U.S., the state boards of pharmacy do and those state boards could do so for foreign pharmacies as well.
Now what about drug quality in Canada vs. the U.S. There is no empirically-driven study, of which I’m aware, to support that drugs sold in Canada are any less safe than here. In fact, I have reason to believe they are safer but I’ll save that for another post. Happily going further, medications sold throughout the European Union, Australia, New Zealand, Japan, Singapore, and many other countries are probably equally as safe as you’ll find here, too.
In the poorest countries with very weak regulations, however, counterfeit and substandard drugs are a serious problem, but one that may be improving. Medications sold or made in India are somewhat in a middle ground, which we’ve written about in detail here. In fact, Mr. Bate’s recent testing of Internet drugs showed that credentialed U.S. and international pharmacies are equally not perfect because India’s standards may be lower. However, his research and, well, FDA’s own efforts, demonstrate that the best Indian drug companies can and do make the highest quality medications. And thank God for that. About 40% of all generic medications sold in U.S. pharmacies are Indian-made. And since well over 80% of all medications dispensed in the U.S. are generic, about 1/3 of the medications sold in U.S. pharmacies are Indian.
But let’s conclude by getting down to the basics. Money; fairness; freedom. Medications cost far less outside the U.S. Just because there are safety concerns doesn’t make it right to prevent a person from buying a medication from another country, especially when they cannot afford it locally. The thing to do is help them do it most safely: guiding them to credentialed online pharmacies. Shouldn’t it be their personal decision?Tagged with: Bernie Sanders, Congress, Corey Booker