The FDA is set to enforce a ban on personal importation of drugs from abroad for personal use. In doing so, the agency is jacking up the cost of medications used in my household by nearly $1500 a year. That is just for one medication. And it’s an over-the-counter drug in the country we order from but available only by prescription in the United States. It really should be OTC here as well. There should be a lot more OTC drugs available, but I digress.
I’m only on one (inexpensive) prescription drug I pick up from my local pharmacy, but it would be nice to have options. A Texas woman interviewed by the Wall Street Journal currently pays $10 a week for a Canadian prescription drug that costs 100 times more in the United States. She’s not alone. The Wall Street Journal reports more than two million Americans take prescription drugs they ordered from abroad to save money.
Indeed, numerous states have authorized their residents to mail order drugs from Canada, although Florida is the only state that has FDA approval. Other states have passed laws allowing importing drugs from Canada – including Colorado, New Hampshire, New Mexico, North Dakota, Maine, Texas, Vermont and Wisconsin – but the FDA has not signed off on the plans.
Technically the law has not changed, but the FDA is planning to enforce regulations (designed to protect drug industry profits) that in the past the agency quietly ignored for low value drug orders. Now a private firm will be charged with enforcing federal law, and you can expect strict adherence to regulations with no sympathy. More from WSJ:
Zonos, a St. George, Utah-based company that processes customs documentation for foreign mail services, handles much of the mail moving through Canada and other countries.
The FDA says it will continue to evaluate drug imports for personal use on a case-by-case basis, according to a spokesperson for the Department of Health and Human Services. But what does that mean? More from WSJ:
That means Zonos, not customs agents at the border, will effectively decide which packages get through—by checking each one against the FDA’s actual criteria for personal drug imports, most of which have gone unenforced at scale for years.
The following is the FDA’s criteria for personal drug imports, according to WSJ:
The FDA generally won’t stop a personal shipment if it treats a serious illness with no good U.S. treatment, isn’t marketed to American consumers, carries no unusual safety risk and comes with a doctor’s note for a 90-day supply or less. Before the rule change, that was rarely checked upfront for parcels under $800 in value because of a decades-old customs exemption for low-value mail.
The policy change is essentially shutting down any chance to reduce drug costs for 70 million Baby Boomers reaching the time in their lives when they begin to use more prescription drugs. There are many other people (more than two million according to JAMA Network Open) who currently import a drug or two. It is difficult to get my doctors to change the pharmacy they send my prescriptions to electronically when prices change from one pharmacy to another. Imagine how difficult it will be to get my doctor to create a hardcopy of a prescription that I send to a foreign pharmacy, who then must include it in a shipment. Good luck with that.
To make matters worse, about 80% of the drug market is controlled by the three biggest pharmacy benefit managers (PBMs). They have such concentrated power that they have stopped competing to lower drug prices charged to Americans and instead profit off higher prices. Patients often find a prescription is cheaper to pay cash through a discount card than using pharmacy benefits through their drug plan.
Americans will still be allowed to bring back small amounts of prescription drugs when traveling abroad. It is unclear what prompted the sudden crackdown on person drug imports, especially since previous administrations quietly encouraged it or tolerated it. More from WSJ:
The government is trying to crack down on illegal contraband that it says comes into the country through low-value foreign shipments that don’t pay tariffs or submit data for tracking.
Yet, analysis of intercepted drug imports only found 33 packages of opioids out of 53,000 drug shipments (and no fentanyl). Data from Customs was similar: only 227 opioids (half fentanyl) out of 30,000 drug shipments intercepted.
I’m not usually a proponent of conspiracy theories but it makes me wonder if there were not discussions with drugmakers who want to close the arbitrage opportunities as more Americans order their drugs from abroad at reasonable prices.
Read more at WSJ: Americans Are About to Lose Access to Cheap Gray-Market Prescriptions From Canada
This is not what I would have expected with RFK leading HHS.