One man's foreign-source warning is another's generics bash

"Most unfortunate" is what Roger Bate says of the headline of his opinion piece in last week's Wall Street Journal--"Beware the Risks of Generic Drugs"--because the article "really wasn't about generics at all." Neither was the original research report, which was penned by the Legatum Fellow in Global Prosperity at the American Enterprise Institute. A brief summary of the article ran in last week's newsletter.

Bate's report is called Dangerous Substandard Medicines: An Increasing Global Problem. It shows drugmakers in poorer parts of the world "commit obvious and major production flaws so serious that many of their products fail even the most basic quality-control tests." Bate says in an email that he's had "quite a few comments" on the WSJ piece [35 printed in the paper as of Monday]--most, unfortunately, related to the headline. 

With its misleading headline, the story was read by some as an attack on generic drugs and drugmakers. But its intent, according to Bate, is to discuss various drug quality problems--some in the U.S., but most not. "My work and most of my research is on products made and consumed outside of the U.S.," he tells us.

One FiercePharmaManufacturing reader, a VP at a generics maker who will remain anonymous per his/her CEO, felt the sting. "This article seems more like Big Pharma scare tactics on generics in general than a nuanced assessment of the issues in importing products from China," he wrote to us in an email.   

As proof, the reader points to the penultimate sentence, adding the italics: "But at the very least, patients should realize that not all the drugs they take, even allegedly bioequivalent generics, will in fact work perfectly." The sentence appears in Bate's report and our summary, but not in the WSJ piece.

"Coming from the generic sides of the business," our reader says, "I can say that I have had my share of problems in trying to develop some generic products simply because of the wide variability in the [FDA's] reference listed drug (RLD). This is why FDA has had to resort to a partial and/or full replicate reference-scaled average bioequivalence approach for these kinds of RLD products.  

"FDA works very hard to ensure that products that it grants [an Orange Book therapeutic equivalence] rating of AB are [bioequivalent].  And I can also tell you that the generic industry works even harder to develop products that meet these very tough standards."

In response, Bate says: "The point is that not all products that claim to be generics are in fact bioequivalent (hence the word 'allegedly'). I certainly wasn't saying that generics (bioequivalent products) won't work. In our sampling of products made by large pharmaceutical companies in well-regulated environments (including the best Indian producers and all producers in the EU and U.S.), none exhibited easily detectable problems." That statement includes generics makers.

Our reader also takes exception to chart data displaying variability in API content and impurities in copy versions of docetaxel versus innovator drug Taxotere; the chart doesn't identify which of the 32 versions listed are FDA-approved for use in the U.S. Our reader says the data suggest that the copies are supposed to be bioequivalent, adding that the vast majority of those listed are not approved for use in the U.S.

Bate replies that the point of the graph is to show the wide variation in basic product quality. "Non-specialists [who read this report] will have no idea that so many producers make such woeful formulations...Many of these copies will not work, given how poorly many of them perform in basic tests of API content."

I think the Bate report underscores a problem that is far bigger than most of those outside the drug-making profession realize. WSJ headline aside, that confusion can exist within industry discourse between poorly manufactured products and well-made generics may partly explain the public's unfavorable view of "pharma," whether that be Big Pharma, generics-makers, foreign suppliers or all three. - George Miller