Introduction

For years, generic drugs have been taking over the pharmaceutical industry as the more cost-efficient option compared to brand names. Americans fill one billion prescriptions for generic medications yearly and rely on them to work just as well as brand name medications; however, the comparable efficacy between brand versus generic is controversial. Many consumers choose to purchase the more expensive brand medication, although several companies manufacture a comparable generic, in order to avoid risks that may be hazardous to their health. Many factors must be considered when deciding whether brand or generic is the smarter option, including cost, efficacy, and tolerability.

Background

According to the FDA, a brand-name drug is a drug marketed under a proprietary, trademark-protected name. Once the patent for the brand-name drug expires, it allows generic drugs to come into the market at a much cheaper cost. The majority of generic medications are considered safe by the general public because the FDA has approved them. Brand-name consumers doubt the true make-up of generic medications and its similarity to the brand name. The concept of a cheaper drug makes the generic seem less efficacious with a greater risk for side effects.

Issue

Can generic drugs be considered a suitable alternative to brand-name drugs?

Rule

Generic drugs can be considered a suitable alternative to brand-name drugs if:

  1. They are indicated for the same treatment
  2. They have the same adverse effect profile

Analysis

Indications

Generic drugs can be considered a suitable alternative to brand name drugs. Before getting approved by the FDA, a generic drug must have the same active ingredients as the brand-name drug while also meeting the safety and quality standards. Additionally, the FDA requires that the generic drug be the same as a brand-name drug in  dosage, safety, strength, the way it works, the way it is taken (dosage), the way it should be used, and the health conditions that it treats (indications).

Many are concerned with the reason generic drugs are significantly cheaper, which may correspond to a less efficacious drug; however, that is not the case. They are simply less expensive because these manufacturers are spending less on marketing, advertising, and research and development. Because of the trademark law, manufacturers must often alter the appearance of generic drugs to differ from the original.

Adverse Effect Profiles

The company performs basic evaluations of sustainability and  “therapeutic equivalence” of generic drugs, which the FDA reviews. Drug products evaluated as “therapeutically equivalent” can be expected to have equal effect when substituted for the brand-name product. The only difference in ingredients between brand-name and generic drugs are the non-medicinal fillers, which may be ingredients that change the color of the drug. The manufacturer of generic drugs must provide a data from studies showing that these non-medicinal ingredients have not altered the quality, safety, and effectiveness of the generic drug. Generic drug manufacturers are also inclined to perform “comparative bioavailability” studies that explain the effects of these medicinal ingredients in healthy human volunteers. During these studies, volunteers get both the brand-name and generic drug. The study must show that the generic drug delivers the same amount of medicinal ingredient at the same rate as the brand-name drug.

Conclusion

Since generic drugs have the same indications and adverse effect profiles as their respective brands, they are suitable alternatives.

For more information on this issue, contact the Kulkarni Law Firm.