I received an interesting mailer last week from a company selling Lucentis and Eylea sourced from Europe and other non-EU countries to US-based retina specialists. The Lucentis was labeled from Novartis and the Eylea from Bayer. It goes without saying the prices of these imported drugs were considerably lower than US prices. It sounded perfect. Get licensed drug that is the same as what we use here for a lot less. Patients benefit from receiving labelled drug, and physicians benefit from increased revenue. Not so fast.
Of course, this practice is absolutely illegal and purchase of these internationally sourced drugs is against US law, as the FDA restricts the importing of drugs from overseas if a version is available domestically. However, it raises some interesting questions. Why are they illegal, since they are likely made in the same place that Lucentis from Genentech and Eylea from Regeneron are made? The quick answer is that since these versions are not licensed in the United States by the FDA, the manufacturing process is not approved by the FDA and they cannot be sold here. Why can’t we use drugs licensed and made per FDA standards in the United States and sold in other countries? The main reason is that there are no reciprocity agreements for drug trade between countries.
If a drug is approved worldwide but not in the United States, why can’t we just import it? The short answer is, you can. Take for example deflazacort (a drug to treat the rare Duchenne muscular dystrophy) that US patients could import from the United Kingdom and other countries for around $1,600 a year when it was not available here. The FDA guidance allows the personal import of drugs that are not approved if the drug is for a serious condition for which no effective treatment is available in the United States, there is no promotion of the drug in the United States, the drug does not represent an unreasonable risk, and less than a 3-month supply is imported for personal use. This was perfect for the steroid deflazacort.
Why can’t we just bring in any nonapproved drug like any other commodity? Safety is the main reason. Take for example thalidomide, a sedative sold by a German company in the 1960s to prevent morning sickness in pregnant patients but which caused severe birth defects. Interestingly, thalidomide eventually did gain FDA approval in 2006, but for the treatment of multiple myeloma due to the pioneering work of Judah Folkman and Robert D’Amato.
So, what about deflazacort? When a US company received FDA approval for the drug, the price increased to almost $90,000 a year, and importing the drug became illegal. For a pill that costs around $1/pill in Canada, this was robbery, and we have discussed this here many times. Our pricing system is broken, because we must subsidize the rest of the world’s clinical research with our higher drug prices. That means if you receive this flyer, beware. RP
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