Have We Come Full Circle? 

 

We previously reported on the Office of Generic Drugs (OGD) initiative to make generic drug products look more like their brand name counterparts (here and here).  The FDA Guidance on Size and Shape of Generic Products brings into focus the issue of functionality.  In addition, Dr. John Peters, the newly appointed Deputy Director of OGD, just posted a piece on the FDA website on the “Importance of the Physical Characteristics of Generic Drugs” (here).  In that article, Dr. Peters noted that:

“When the appearance, particularly the color and shape, of a generic drug is different from the RLD [reference listed drug], it becomes increasingly difficult for patients and health care professionals to correctly identify medications. The risk of error is especially high with elderly patients who take multiple medications each day and are used to sorting their medications by shape, color, and size.”

Dr. Peters also noted that OGD has taken a particular interest in what he termed “Patient-Focused equivalence” or something that I have termed “functionality” when I have been questioned about whether the concept of generic drug “sameness” had taken on new definitions.

So now it is time for a brief history lesson and also a current day wake-up call!  When Hatch-Waxman was in its infancy in 1984, the generic industry was worried about something called “trade dress infringement” as it worked to develop its generic products.  The concept of ANDA sameness included a product that had the same dosage form, route of administration, strength, and active ingredient.   In an effort to avoid a problem with trade dress infringement, the generic manufacturers designed their generic products to look different than the RLD that they were copying. If the brand product was blue, they made their product white.  If the brand product was shaped like a triangle, they made theirs round.   The generic industry was more worried about patents on the active ingredient and their use than on the physical characteristics of the product.

Over the course of time, firms made unique shapes (like Valium tablets with the “V” inside, or with unique shapes and scoring configurations like Desyrel Tablets) and the generic firms avoided running afoul of those unique characteristics by making their products different.

However, the FDA received complaints about actual and potential medication errors and confusion in the marketplace by tablets or capsules that were of a different shape, size, or color.  How can a patient (or pharmacist, for that matter) catch a dispensing error in a product has 5 strengths and all of the strengths are the same size and same color?  If a patient gets a generic product substituted that is twice the size as the brand name drug they have been taking for years, what is the patient to think? All of these are legitimate issues that can impact patient acceptance of generics, as well as patient compliance.

But what happened a day or two ago that may drive difference rather than similarity as the preferred option for generic drug design?  A Delaware Federal Judge issued a temporary restraining order against Dr. Reddy’s from selling a copy of the AstraZeneca’s drug Nexium because the color of the generic product was too close to that of the brand name product.  The industry and the FDA need to watch this case closely, because if FDA is going to be forcing generic products to look more like the brand they copy, they may be pushing the generic right into the hands of the brand name company’s lawyers.