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This week, an advisory panel of the FDA unanimously concluded that a widely used nasal decongestant is ineffective and basically worthless. The ingredient, phenylephrine, is found in numerous over-the-counter remedies—including Mucinex, NyQuil, and Theraflu—in all, in some 250 different products worth $1.8 billion in sales last year.
Decongestants in general are not very good. There is a well-known rebound effect. You get some relief for a while but then are more congested than ever.
As it happens, there is a near-miraculous generic cold medicine, ambroxol, that is available over the counter all over the world, but not in the United States. I stumbled on this medication last year when I was in France and had a bad cold. I went to the local pharmacy and asked if they carried something like Mucinex or Robitussin.
“We have something much better,” the pharmacist said. As I wrote last December in the Prospect, ambroxol works on an entirely different biochemical principle, to thin sputum and facilitate productive coughing, and also operates as a pain reliever and gentle decongestant with no rebound effect. My wife and I experienced it as a miracle drug for coughs and colds. A box cost eight euros.
Why is ambroxol not available in the U.S.? A comprehensive 2020 review in the journal Multidisciplinary Respiratory Medicine, available on the NIH PubMed site, found it safe and effective.
But no drugmaker has ever sought FDA approval, a time-consuming process requiring three stages of clinical trials. Why not? Because drugmakers could not make enough money with a generic to justify the expense. It’s obviously crazy to require this laborious review process for a generic that has been widely used in Europe since 1978, but this is how our system works.
Here is where President Biden could come to the rescue of cold-sufferers. He could direct the FDA to fast-track the approval of ambroxol for sale in the U.S.
When the U.S. ran short of infant formula in 2022 due to the misfeasance of a highly concentrated and profit-gouging industry, Biden ordered agencies to cut red tape and increase imports of formula from several countries, and we relied on their regulators to certify that these products were safe.
In fact, we already rely on EU agencies to certify that exported foods in general are safe and without toxic residues. European regulators are trusted with many other reciprocal delegations of regulatory authority, such as pollution standards in cars.
The European Medicines Agency, the counterpart of the FDA, has an excellent record. Under a new fast-track process, it would take just a few days for the FDA to review EMA records on the history of ambroxol in Europe to confirm that it has been safe and effective for decades.
Biden could also direct the FDA to establish a new process to fast-track approval in general for other generic drugs approved for sale in Europe but not in the U.S. That would save consumers money and give us access to beneficial medicines that we are now denied because of the manipulative greed of Big Pharma combined with an antiquated and captured FDA.
Al Gore was hailed as the man who helped bring us the internet. Joe Biden could go him one better. He could bring Americans relief from the common cold.
