Texas A&M researcher receives FDA grant to develop test to bring generic eye medications to market

The cost of some medications can be staggering, especially if these medications are only available as brand-name drugs. One reason brand-name drugs cost so much to develop, as much as $2.6 billion, is that it can take about 14 years to develop them, ensuring drug safety and efficacy through rigorous regulatory approval processes.

Brand-name products may be reproduced as generics once the 20-year patent protection expires, allowing for greater access to medications at lower costs.

To ensure that generic drugs are therapeutically equivalent to brand-name drugs with similar characteristics and clinical effects, the U.S. Food and Drug Administration (FDA) has testing methods and application processes for drug companies.

The FDA recently awarded Srinath Palakurthi, Ph.D., associate professor of pharmaceutical sciences and director of graduate studies at the Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy, a $250,000 grant to support the development of a test method for finding therapeutic equivalency of topical eye medications. Currently, there are tests for tablets and capsules, but not for topical eye medications.

The test method will show whether the medication is equally effective in both the brand and generic formulations. More importantly, it will help reduce the amount of time and money required to bring a generic product to the market.

“Currently there is a lack of predictive assays for drug release for topical ophthalmic emulsions and suspensions,” Palakurthi said. “It is critical to develop an appropriate drug release method that can help compare and contrast eye products and also predict the drug release in the eye. Such a quality control test would guide the product development process and accelerate the product approval of ophthalmic formulations.”

The grant was awarded through the Center for Drug Evaluation Research, which ensures that safe and effective drugs are available to improve the health of people in the United States. The center regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

Palakurthi plans to develop the new test method in the coming year. This test method will pave the way for future topical ophthalmic products in generic forms to be validated for patients who need the medications. Palakurthi’s goal is to create a test method specifically for eye products that have expired patents and are ready for the generic formulations.