Robert Kuttner found the best flu treatment while visiting France and is rightly upset that it isn’t available in the United States:
Towards the end of our stay, my wife and I developed a bad cough (thankfully, not COVID). We went to our wonderful local chemist for something like Mucinex or Robitussin, not great but better than nothing.
“We have something better,” he said. And he did. It is called ambroxol. It works through a completely different chemical system, thinning the sputum, making it easier to cough, and acting as a pain reliever and decongestant without side effects.
We saw it as a miracle cure for coughs and colds. The box costs eight euros.
Ambroxol is available almost everywhere in the world as a generic. It has been widely used since 1979.
But not in the US
He continues the story:
…You can’t get ambroxol in the US because of the Food and Drug Administration’s failure to grant the same recognition to generic drugs approved by its European counterpart, the European Medicines Agency, when it has long been proven safe and effective. To get FDA approval to sell ambroxol in the US, the drug company will need to fund extensive and expensive clinical trials. Since it is generic, as cheap as aspirin, no drug company can be bothered.
…I have filed a petition with the FDA, asking it to implement a fast-track process, whereby generic drugs approved in Europe, and proven to be safe and effective, can receive the same approval in the US.
This would result in the approval of ambroxol as an over-the-counter medicine for coughs and colds without unnecessary clinical trials. And if ambroxol has real benefits for Parkinson’s, it will already be well established in the US as a cheap generic.
Influenced by my work on FDA reconciliation aka peer approval, Ted Cruz introduced a bill, the Impact Act to accelerate approval in the United States for drugs and devices already approved in other developed countries. Similarly, the AOC noted that the FDA is the world’s laggard in approving advanced sunscreens. Perhaps there is an opportunity here for bipartisan support.
Hat tip: Excellent Scott Lincicome.
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