Today I learned about ambroxol, a cold medication available over-the-counter, much like Mucinex and Robitussin, but unlike those two ambroxol may actually work. It’s been available in Europe for almost 50 years and costs around $5 per box, but alas:
You can’t get ambroxol in the U.S. because of the failure of the Food and Drug Administration to grant reciprocal recognition to generic medications approved by its European counterpart, the European Medicines Agency, when they have long been proven safe and effective. To get FDA approval for the sale of ambroxol in the U.S., a drug company would need to sponsor extensive and costly clinical trials. Since it is a generic, as cheap as aspirin, no drug company would bother.
If the drug is that good and that cheap a trial should be neither extensive nor costly — it would certainly be cheaper than the $10 billion the American tax payer gave for Paxlovid, with potentially many more people benefiting. So why not have the NIH run the trial and the FDA approve the drug? Would that not be faster than trying to pass any legislation through the United States Congress?
More generally, I would like economists, politicians and the general public to understand that well-run clinical trials do not have to be complicated and expensive. They are not a limited resource going up in price because of low availability and high demand, requiring us to think of workarounds. In fact, there are more patients than ever, more researchers than ever, and more technology than ever to make them economical and efficient.
Of course, if your notion of a clinical trial is one that includes mountains of paperwork and research bloodwork gathered on the off chance it may someday be needed then yes, it can get pricey. But that is like complaining that pianos are really expensive and unaffordable because the price of a Steinway piano has gone through the roof since the early 1900s. You can play music on a Casio just fine, and if I were an economist I would really want to know why on Earth almost everyone in the pharmaceutical and biotech industry was getting grand pianos instead of electronic keyboards.
(↬Alex Tabarrok, who as an economist interested in drug pricing may want to look into the cost of clinical trials)