COMMENTARY

Generic vs Brand-Name Drugs: An Ongoing Debate

Roger F. Steinert, MD

Disclosures

April 13, 2012

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Hello. I am Dr. Roger Steinert, Professor and Chair of Ophthalmology at the University of California-Irvine and Director of the Gavin Herbert Eye Institute.

The topic that I would like to discuss in this month's blog is generic vs brand-name drugs. Generic drugs, in principle, have the appeal of a seemingly lower cost, and there is certainly lots of pressure from the health insurance companies to use generics whenever possible. But the concern is that generics are not necessarily equivalent to brand-name drugs, and it is not just an issue of the patent running out.

An example of this came up in a very peculiar way in June 2011 with a US Supreme Court decision. Even the justices who made the decision said that it was fairly absurd, but it was an issue of federal vs state law. The issue is that when a manufacturer of a brand-name drug finds out about a possible adverse event, they are required to change their labeling, whereas the makers of a generic equivalent are not required to change their labeling. So, there is no warning to patients and no obligation on the part of the generic drug manufacturers to warn patients about a potential adverse event.

This is an issue of the way the labeling law has been written. The opinion of the Supreme Court seemed to be that this was absurd, but it was law and Congress had the power to change it if they didn't like it. There have been all sorts of ramifications. At a minimum, this focused people on the issue of generic drugs and whether they are wonderful things that save us money or whether they have a potential downside.

In ophthalmology we have a very special situation. We are talking largely about eye drops and the effect that they can have on a very sensitive part of the body.

When the US Food and Drug Administration (FDA) allows a generic drug to be marketed, the manufacturer has to use the same concentration of active ingredient and the same route of administration as the branded drug that was previously approved by the FDA. But that is the only requirement. There is no review, no burden of proof, no burden of testing the so-called "inactive ingredients," which include things like the preservatives and other components that can have a significant effect on the eye.

Probably the most famous instance of this issue occurred in 1999 when a number of corneal melts were recognized and ultimately tracked to generic diclofenac, a nonsteroidal agent. This problem was not occurring with the brand-name drugs, and ultimately the problem was attributed to variations in a so-called inactive ingredient (except with respect to the eye, where it apparently was quite active) that was in the generic drops, and this led to a surge in branded nonsteroidal agents. Now we are facing the same issue with steroids, nonsteroidal agents, multiple antibiotics, and glaucoma medications. Many brand names that we have been accustomed to using are going off patent and the generic equivalents are coming out.

The manufacturers are also using "line extensions," which is when the drug manufacturers perform a relatively minor modification in one of their drugs and are then able to get a new patent for it and have patent protection for the new formulation for another extended period of time.

On the one hand, this sounds like a way of inappropriately getting more money from the consumer. But on the other hand, it means more scrutiny and higher expectation for the brand-name drugs. As a result, patients get better-quality medications.

This debate is expected to go on indefinitely. The intensity of the debate is going to increase, in part because the cost of bringing a new drug to market has been rising exponentially. This cost is much higher than the rate of inflation. It is commonly said that it takes more than $100 million -- and sometimes close to $1 billion -- to bring an entirely new class of pharmaceuticals to market, not to mention the exposure that the manufacturer has to class-action lawsuits and tort actions.

From our point of view as practicing ophthalmologists, we have to be sensitive and aware that our patients may not be getting what we think they are getting, and keep an ear tuned to complaints about stinging and burning that we didn't formerly hear with respect to a particular class of medication. If necessary, we can try to force the use of a branded medication, although in many cases the third-party payers simply won't pay for the brand name even if you specify it; it can be quite a battle to justify it and get them to pay for it. We want to avoid sight-threatening complications. It is bad enough to have unnecessary discomfort, but if we get into more situations like corneal melting, we are going to see even more issues related to generics vs brand-name drugs.

So, just a word of caution: We should be attuned to that potential, and certainly if you think you are seeing some problems with a certain medication, whether it be branded or generic, be sure to report it to the FDA promptly so that an investigation can take place into whether this is an isolated incident or represents a bigger trend that could be dangerous and is something we all need to know about.

This is Roger Steinert for Medscape. I hope you have enjoyed this blog, and please feel free to comment.

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