Branded or generic drugs: What's in a name?

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Although generic medications approved by the FDA are identical to the innovator in their active and inactive ingredients, prescribers must be cognizant about sources of problems associated with the use of ophthalmic generic drugs.

Dr. Kahook

By Cheryl Guttman Krader; Reviewed by Malik Y. Kahook, MD

Generic medications can offer cost savings for patients and conserve limited health-care resources.

However, there are potential problems accompanying the use of generic ophthalmic drops. With those issues in mind, there is an onus on prescribers to monitor patients carefully and report concerns to the FDA.

The lower cost of generic products has value for patients in terms of increasing access and possibly compliance, but it also has potential societal benefit, explained Wiley A. Chambers, MD.

“For the first time, in 2012, there was a drop in the annual expenditure for prescription medications, and that was due to an increase in the number of generic products dispensed,” said Dr. Chambers, clinical professor of ophthalmology, The George Washington University, and deputy director, Division of Transplant and Ophthalmology Products, Center for Drug Evaluation and Research, FDA, Silver Spring, MD.

“Our ophthalmic resources are limited, and if we make the best use of our dollars by using generic products when available, we can spend the money on developing innovator products for new indications,” he reasoned.

Malik Y. Kahook, MD, The Slater Family Endowed Chair in Ophthalmology and Professor of Ophthalmology, University of Colorado School of Medicine, Aurora, CO, presented the case for branded medications.

Dr. Kahook noted that the majority of his patients use generic medications and that he believes generics are typically safe and effective. He also said he believes in cutting health-care costs, but not in cutting corners to get there.

“In cases where product approval was obtained without prior clinical data, our duty is to alert the FDA to confusing variables as well as to potential efficacy and safety issues that can be missed with in vitro testing,” Dr. Kahook said. “The duty and burden is on all physicians to ensure patient safety.”

Defining generic drugs

Dr. Chambers explained that a generic drug is a product that is approved by the FDA after being submitted as an Abbreviated New Drug Application. A generic is intended to copy the safety and efficacy of the innovator (or a designated generic to the innovator if the innovator is discontinued). A generic is expected to contain the same active and inactive ingredients as the innovator product. Since all of the ingredients in ophthalmic solutions are dissolved, order of ingredient mixing and particle size is a moot issue.

Dr. Chambers also clarified that before the regulations for generic medications existed, multiple companies made their own versions of a product containing the same active ingredient (e.g., prednisolone acetate 1% or diclofenac 0.1%). These individual products are each considered an innovator as they have unique formulations and were approved based on data from clinical trials, not in vitro testing. Currently, however, there may be generic versions of each “innovator.”

Areas of concern

As pointed out by Dr. Chambers, “generics” manufactured outside of the US are not regulated by the FDA. They may differ in their inactive ingredients compared with the innovator product, and those differences can account for differences in efficacy and stability relative to the innovator. As shown by Dr. Kahook, foreign generic products have also been found to be affected by problems with contamination.

These foreign medications make their way into the hands of U.S. consumers via mail order purchases. In addition, Dr. Kahook pointed out that some U.S. companies are distributing generic medications manufactured outside of this country.

“Regulatory standards for generics can be different in different parts of the world,” Dr. Chambers said. “We have tried in the United States to keep our products to be true generics when they are ophthalmic solutions, but the lesson for physicians and patients is to be careful about all mail-order products, generic or otherwise.”

Container differences between generic and innovator products also create the potential for problems with generics. Dr. Chambers acknowledged that regulations on generic medications were developed for solid oral formulations, not ophthalmic drops. As pointed out by Dr. Kahook, differences in bottle material and dropper configuration with ophthalmic drops can affect the ease of use and volume of drug dispensed. In addition, differences in container appearance, including cap color and dropper configuration, can be a source of confusion for patients.

“Saying that generics are equivalent to the branded medication based on their having the same active and inactive ingredients is not true and does not cover the whole story as there can be issues with bottle type, bottle color, and also labeling issues,” Dr. Kahook said.

He noted that while generics are supposed to have the same label as the innovator, the FDA recently proposed a rule that would permit generic drug makers to update their label if they received information about potential safety problems.

Remaining vigilant

To minimize problems with generic medications, Dr. Kahook said that all patients seen at the University of Colorado are asked to bring all of their medications to every visit. Any changes in medication and manufacturer are documented, and patients who changed from a branded product to a generic are asked to return for earlier follow-up.

‘This represents a cost and effort burden on the clinic, but we want to stay alert for changes in efficacy or new signs and symptoms of an adverse event,” Dr. Kahook said.

Dr. Chambers agreed that it is important to know about any changes in medications patients are using and to monitor patients for any changes in efficacy or safety. However, he pointed out that a switch to a generic may not be the only culprit as problems can arise for a variety of other reasons.

In addition, Dr. Chambers encouraged physicians to be attentive to medication container-specific problems with generic ophthalmic medications and to bring them to the attention of the FDA.

“In many cases, the FDA can do something about it,” he said.

Wiley Chambers, MD

E: wiley.chambers@fda.hhs.gov

Dr. Chambers has no relevant financial interests to report. His presentation reflects his personal views and not necessarily those of the FDA.

Malik Kahook, MD

E: malik.kahook@ucdenver.edu

Dr. Kahook is a consultant to the FDA and to several manufacturers that make branded and generic ophthalmic medications.

Dr. Chambers and Dr. Kahook spoke as opponents in a point-counterpoint session on branded and generic medications at Glaucoma Subspecialty Day during the 2013 meeting of the American Academy of Ophthalmology.

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