Robert Kuttner discovered an excellent treatment for the common cold on vacation in France and is rightly outraged that it’s not available in the US:
Towards the end of our stay, my wife and I both had severe coughs (luckily not COVID). We went to our wonderful local pharmacist looking for something like Mucinex or Robitussin, which aren’t great but better than nothing.
“We have something much better,” he said. And he did it. It’s called ambroxol. It works on a totally different chemical principleto thin sputum, facilitate productive coughing and also acts as a mild analgesic and decongestant without rebound effect.
We experienced it as a sort of miracle medicine for coughs and colds. A box costs eight euros.
Ambroxol is available almost everywhere in the world in generic form. It has been widely used since 1979.
But not in the USA
…You can’t get ambroxol in the United States due to the failure of the Food and Drug Administration to grant reciprocal recognition to generic drugs approved by its European counterpart, the European Medicines Agency, although they have long been proven to be safe and effective. To gain FDA approval for sale of ambroxol in the United States, a pharmaceutical company would have to sponsor extensive and expensive clinical trials. Since it’s a generic, as cheap as aspirin, no pharmaceutical company would care.
…I petitioned the FDA, asking it to create a fast-track procedure, whereby generic drugs approved in Europe and found to be safe and effective could gain reciprocal approval in the United States.
This would allow ambroxol to be approved as an over-the-counter cough and cold medication without unnecessary new clinical trials. And if ambroxol turns out to have real benefits for Parkinson’s disease In addition, it would already be well established in the United States as an inexpensive generic.
Influenced by my work on FDA reciprocity, i.e. peer approvalTed Cruz introduced a bill, the Act of Result to expedite approval in the United States of drugs and devices already approved in other developed countries. Likewise, AOC noted that the The FDA is far behind the world by endorsing advanced sunscreens. Perhaps there is an opportunity here for bipartisan support.
Hat tip: excellent Scott Lincicome.
