How Pharmaceutical Companies Are Keeping Americans From Doing Something The Government Says They Can Do

from the taking-options-away dept

The EFF's series on "shadow regulation" continues, this time exploring how American pharmaceutical companies are keeping affordable medication out of the hands of Americans. The examination goes beyond what's already common knowledge: that patents and regulatory capture have created a skewed marketplace that ensures healthy profit margins, rather than healthy Americans.

But what's not generally known is that the pharmaceutical companies have "partnered" with internet intermediaries to lock Americans out of purchasing options specifically approved by the FDA. To hear big pharmaceutical companies tell it, purchasing drugs from other countries (where the price is generally lower) is extremely dangerous, if not completely illegal. But that's simply not true.

[D]iscretionary guidelines developed by the Food and Drug Administration (FDA) and enforced by the CBP allow American consumers to import a 90-day supply of some prescription medications for personal use, including by bringing them across border checkpoints in personal luggage, or by mailing them from overseas. In the latter case, a large market exists for pharmacies registered in other countries such as Canada, Australia and Turkey, that will accept online orders and mail genuine pharmaceuticals to American consumers at cheaper than local prices.

Multiple industry groups -- most of them using the word "safe" in their names to insinuate that purchasing drugs anywhere but where they want you to is inherently "dangerous" -- have blacklisted certain foreign sellers and have pushed for internet service providers to enforce the blacklists.

The Alliance for Safe Online Pharmacies (ASOP) and Center for Safe Internet Pharmacies (CSIP) are two of these groups. Both groups feature a lot of overlapping membership but having two separate organizations gives this the appearance of more membership diversification than there actually is. While there's nothing inherently bad about wanting to ensure Americans purchase legitimate medications from foreign vendors, the blacklists cover more than just questionable sellers.

Two registers of online pharmacy websites are approved by both the ASOP and the CSIP. These are run respectively by LegitScript, and by the National Association of Boards of Pharmacy (NABP) under the name Verified Internet Pharmacy Practice Sites (VIPPS). A third, independent register is run by the eponymous PharmacyChecker.com, which the ASOP and the CSIP do not recognize. This is because while all three exclude sellers of fake and counterfeit drugs from their approved lists, only the U.S. pharmaceutical industry-run registers LegitScript and VIPPS also exclude overseas online pharmacies that supply genuine drugs to Americans under the FDA's personal use policy.

The shadow regulation keeps American purchasers away from legitimate sellers with lower prices. Going forward, ICANN's domain name registration is going to further prevent Americans from accessing more affordable drugs. These groups have pressured ICANN into using the same skewed blacklist when approving .pharmacy domains. While there are still other top-level domains available that may also help bring customers to legitimate vendors these groups want to lock out of the market, that too may change in the coming months. The National Association of Boards of Pharmacy (NABP) wants ICANN to police the web for it and, hopefully, to shut down domains owned by foreign medical vendors it doesn't like.

If it can't force ICANN to bend to its will, it will use tools it already has in place: pressuring online payments providers and ad services to cut off support for any seller it hasn't whitelisted.

This all helps ensure the industry can sell you drugs at the price it wants, rather than the price the market defines. Somehow, the exact same medicine produced by the exact same company should cost more simply because an American pharm tech put it into a bottle and printed a label, rather than someone who lives outside US borders.

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Filed Under: big pharma, drugs, grey market, pharmaceuticals, reimportation, shadow regulation