FDA is asking for public comments on bioequivalence testing of generics

The US Food and Drug Administration (FDA) is calling for public comments on bioequivalence testing of generic drugs, in response to a citizen’s petition filed by the executive chairman of Pharmaceutical Scientist, Dr Sarfaraz K. Niazi.

Public comments have been requested specifically relating to the novel dissolution methods to allow biowaivers for all types of drugs. Niazi’s argument is to use a process called thermodynamic equivalence to accelerate the approval process for generic drugs and thus getting medicines to patients faster and more cost-effectively.

Thermodynamic equivalence removes the need for blood level studies to determine differences between products and instead identifies dissolution conditions that can discriminate differences in chemical potential. This process was created by Niazi and can be used to assure life-cycle clinical equivalence of a generic product and provide a critical measure of GMP compliance.

The FDA has agreed to the theoretical validity of Niazi’s argument. In a response letter to Niazi’s petition, Dr Janet Woodcock, director of the Center for Drug Evaluation Research at the FDA, wrote that her department “is largely responsive to your request that we ‘open comment’ on novel dissolution tests that can be used to establish bioequivalence… Therefore, your Petition is granted….”

“It has taken years of communication with FDA to reach this stage,” remarked Niazi in a press statement.

Niazi is now calling on the scientific community to submit their comments to the FDA. “I am encouraging scientists to respond to this challenge and help reduce the cost and time to approval for both chemical and biologic drugs,” she said.