Drug Information Association Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug...

Area of Science:

• Pharmaceutical Sciences
• Regulatory Science
• Drug Development

Background:

• The US Food and Drug Administration's (FDA's) generic drug program enhances access to affordable, high-quality generic medications.
• Generic drug approval relies on demonstrating pharmaceutical and bioequivalence to reference listed drugs.
• Ensuring therapeutic equivalence requires evaluating clinical relevance of formulation and bioequivalence data.

Purpose of the Study:

• To outline the FDA's regulatory framework for generic drug approvals.
• To describe the role of the Office of Generic Drugs' (OGD's) Clinical Safety Surveillance Staff (CSSS) in evaluating generic drug equivalence.
• To highlight the importance of defining equivalence for maintaining drug quality, efficacy, and safety.

Main Methods:

• Review of the FDA's two-tiered regulatory framework (pharmaceutical and bioequivalence).
• Analysis of clinical relevance in formulation and bioequivalence data for therapeutic equivalence.
• Examination of investigative processes developed by the CSSS to assess allowable differences and equivalence.

Main Results:

• The FDA's framework ensures generic drugs perform identically to brand-name drugs in safety and efficacy.
• The CSSS employs specific processes to investigate potential impacts of allowable differences in generic drugs.
• Case examples (clonidine transdermal, lansoprazole ODT) illustrate CSSS investigative processes.

Conclusions:

• The FDA's generic drug program successfully increases availability of affordable, quality generic drugs.
• CSSS initiatives enhance FDA review processes and improve the quality of generic drugs in the US market.
• Clear definitions of equivalence are crucial for upholding the safety and efficacy of generic medications.