CT Arzneimittel GmbH
Insulin has been a generic drug for a century. Big Pharma has profited by tweaking the basic formula to extend the patent and then raising prices to astronomical levels. One of President Biden’s good deeds, via the Inflation Reduction Act, was to ensure that under Medicare, insulin would cost people no more than $35 a month.
As the Prospect has written, pharma pulls the same caper with basic, simple, lifesaving devices like the EpiPen, and with other medications where drug companies alter one molecule, or in the case of the EpiPen the delivery mechanism, of a generic drug so that they can patent a new, clinically identical product and jack up the price.
Now unfolding is the next pharma outrage. I’ve written about a miracle cold and cough medication called ambroxol. It is far superior to junk like Mucinex and Robitussin, which tend to have rebound effects. A key ingredient in both of those medications was recently found to be worthless.
Ambroxol, which is highly effective, has been available in Europe (and in most of the world) since the late 1970s as a generic. It costs about $5 a box.
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.
Now, it turns out that ambroxol could also be a breakthrough drug for Parkinson’s disease.
In 2009, researchers discovered that ambroxol increased the activity of an enzyme called GCase (glucocerebrosidase) in the body, which is believed to have a role in reducing the progression of Parkinson’s. Professor Anthony Schapira at University College London and the Royal Free Hospital found that when skin cell samples taken from people with Parkinson’s were treated with ambroxol, the level of GCase activity in these cells increased.
This finding in turn led to Phase II clinical trials in the U.K., funded by three nonprofits: Cure Parkinson’s, Van Andel Institute, and the John Black Foundation. These demonstrated further promise, and Phase III trials are about to begin.
You can see where this is headed. If the big drug companies run true to form, we can expect them to develop their own, patentable variant of ambroxol, treating it as a new profit center rather than a mercifully inexpensive generic treatment.
Cure Parkinson’s, the British nonprofit co-sponsoring the trials, says on its website, “If the ASPro-PD clinical trial proves that ambroxol does indeed slow the progression of Parkinson’s, the urgent focus of everyone involved will be to ensure that the drug reaches people with Parkinson’s as quickly as possible.” When did we ever see such a statement from Big Pharma?
The Biden administration could prevent the capture of ambroxol as a Parkinson’s medication and also make it widely available in the U.S. as a treatment for colds and coughs. I’ve petitioned the FDA, asking them to create a fast-track procedure, whereby generic drugs approved in Europe, and well established as safe and effective, could get reciprocal approval in the U.S.
This would produce approval of ambroxol as over-the-counter medication for coughs and colds without unnecessary new clinical trials. And should ambroxol turn out to have real benefits for Parkinson’s as well, it would already be well established in the U.S. as an inexpensive generic.
I don’t have high hopes for the FDA. Too often, the FDA has been one of the government’s more captured agencies, under Democrats and Republicans alike, looking out for the welfare of the drug industry at the expense of the public’s health.
But the FDA is part of the Department of Health and Human Services, and the president is not without influence. During the crisis over a shortage of infant formula, the government temporarily liberalized the usual procedures to let in imported formula.
To his credit, President Biden has been intermittently willing to take on Big Pharma. In August, when he announced the first ten prescription drugs to be subject to price controls, Biden declared: “There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma’s pockets.”
Creation of an FDA fast track for medications like ambroxol should be another of those times.
