Tetracycline. Another example of generic bioinequivalence

Area of Science:

• Pharmacology
• Drug Quality Assurance

Background:

• Government procurement systems often prioritize cost savings when purchasing medications.
• The Food and Drug Administration (FDA) provides batch certification assurances for pharmaceutical products.

Purpose of the Study:

• To compare the quality and efficacy of a generic tetracycline hydrochloride tablet acquired through lowest-bidder purchasing with the innovator capsule product.

Main Methods:

• Comparative analysis of a specific tetracycline hydrochloride tablet formulation purchased via state lowest-bidder contracts.
• Evaluation against the original innovator tetracycline hydrochloride capsule product.

Main Results:

• The tetracycline hydrochloride tablet obtained through lowest-bidder procurement demonstrated inferior quality compared to the innovator capsule.
• Cost-driven purchasing may compromise antibiotic efficacy.

Conclusions:

• Lowest-bidder purchasing of antibiotics, despite FDA assurances, can result in suboptimal drug products.
• Ensuring drug quality and therapeutic equivalence should be paramount in government pharmaceutical procurement.