FDA Standards for Generic Drugs: what are they?

DISCLAIMER

The content provided in this Substack post is for entertainment and informational purposes only and is not intended to serve as medical advice. The views and opinions expressed herein are those of the writer and should not be taken as definitive or authoritative. Readers should not rely solely on the information provided in this post to make decisions about patient care. Instead, use this content as a starting point for further research and consult a qualified healthcare professional before making any changes to treatment or medication regimens.

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Introduction:

As healthcare costs have continued to soar over the years, generic versions of medications have become a cornerstone in patient treatment plans. They offer a cost-effective alternative to brand-name medications, however, misconceptions about their efficacy and quality persist. As healthcare providers, understanding the FDA's standards for generic drugs can better equip us to guide our patients and make informed prescribing decisions.

The inspiration for this post is Latuda having recently gone generic. While it is already a widely-prescribed antipsychotic, the introduction of a generic version will undoubtedly lead to it’s increased utilization. However, for those already on Latuda, this new era invites an array of questions concerning the implications of generic substitutions, their equivalence in quality, efficacy, and the potential impact on patient experiences. Personally, I have already had two patients that were previously stable on Latuda experience dystonia after switching from the brand name to generic version.

Because of these experiences, it seemed prudent to review the FDA’s standards for generic medications. In the subsequent sections, we delve into the FDA's regulations for generic drugs, the impact on prescribing practices, and how to navigate these changes while ensuring optimal patient care.

FDA Standards for Generic Drugs:

The FDA defines a generic drug as a medication that's bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Here's what that involves:

1. Active Ingredient: The generic drug must contain the same active ingredient as the brand-name drug, which is the component that makes the drug effective against the disease or condition it's treating.

2. Strength: The strength of the generic drug must match that of the brand-name drug. This means that the amount of active ingredient is identical in both versions.

3. Bioequivalence: The generic drug must release its active ingredient into a patient's bloodstream at nearly the same rate and to the same extent as the original brand-name drug. According to the FDA, the generic drug's maximum concentration must fall within 80%-125% of that of the brand-name drug, a range generally considered to not impact the drug's therapeutic effect significantly.

4. Inactive Ingredients: While inactive ingredients (known as excipients) don't have to be identical, the FDA reviews them to ensure they are acceptable and don't interfere with the drug's safety, efficacy, or absorption.

Implications for Providers:

Generic drugs have important implications for healthcare providers: