Massive Brand Recalls Widen Doors for Generic Drugs
Driving to work yesterday, I listened to a story on National Public Radio about the effect of Johnson & Johnson’s massive recalls on consumer choices. The news wires and blogosphere have been hyping up a major shift in consumer purchasing in the US from over-the-counter brand-name drugs to generic drugs ever since J&J had to remove from the market millions of bottles of its most popular allergy and fever-reducing medications, including Tylenol, Motrin, and Benadryl.
During the radio show, reporter Andrea Gardner conveyed the following, “My baby Olivia is running a fever. Usually I’d give her Infant Tylenol. But it was recalled back in April. So now, generic acetaminophen is my only choice. I don’t usually give my daughter generic drugs. I buy it for myself, but when it comes to my baby I go with the brand.”
The choice to avoid purchasing over-the-counter generic drugs out of fear that their quality may be less than that of a brand-name drug is quite common among parents, explained consumer psychologist Kit Yarrow during the program: “Parents are just 100% dialed-in to caring for their kids, and especially when we are dealing with health products, if there is any risk at all that you are jeopardizing that—that is going to drum up a boatload of guilt….”
But, adds Gardner, “after months of having only generics to choose from, parents have realized there is no boogieman in the bottle.”
And this is where generic-drug companies have a huge opportunity. They can capitalize on American consumers’ new-found willingness to purchase and use generic drugs not only for themselves, but also for their children. By the time J&J cleans up its image and regains consumer trust in its drug products [another recall of a Tylenol product was issued this week, again for a musty smell], Americans may have decided that the generic drugs they’ve been using as an alternative are just fine and decide that they don’t need to go back to (and pay more for) brand-name products.
Dubious FDA policies
They don’t always require the minimal blood level testing that I’ve mentioned. For very water-soluble chemicals and “non-critical drugs” the FDA accepts data from in vitro studies of tablet dissolution. These cheap tests offer no protection against contaminants, too much excipient, etc. Even worse, the FDA won’t disclose which drugs it has approved solely on the basis of these “biowaivers” (secret deals).
The FDA sees its main job as getting as many generic drug applications processed as rapidly as possible. They don’t want to waste time on inspections or ordering testing of a larger number of “volunteers”. I don’t have to tell you that the metabolism of almost all drugs, including caffeine, ethanol and cannabis extracts is different in the sick and elderly. Those are the main recipients of prescription drugs.
The FDA makes no effort to limit switching from one generic to another, or even to compel pharmacies to tell us if we are switched to a new formulation. A thoughtful patient may assume that he or she got the wrong pills when they find that the new pills look different. The FDA does not require drug labeling by country of manufacture. We had serious problems with Chinese made heparin; I think that drugs made in the US, Canada or Mexico are safer than those from the lowest wage countries.
FDA regulation of drugs, although problematic, is much better than their regulations of new devices, new forms of radiation therapy, etc. FDA policies overall are similar to those of the European Medicines Agency (EMA) and Health Canada.