Legal Responsibility for Generic Drugs

Generic Drugs

When prescribed a drug product, patients can receive the brand-name variety or a generic drug.  Generic drugs have the same pharmacological active ingredients as their brand-name counterpart but are sold at a lower cost, simply because generics are produced when the patents and exclusivities of the brand-name drug end . A major difference between the two types of products, is that generic drugs do not require the same inactive ingredients as its brand-name version.  Thus, depending on the individual, a person may have differing reactions to generic drugs based on the inactive ingredient present.

According to the FDA, generic drugs must be sold with the same label as of the brand-name variety despite the two being manufactured and regulated differently as well as possibly containing different inactive ingredients.

This detail led a brand-name drug manufacturer into trouble last month.  The Supreme Court of California ruled against Novartis, a brand-name drug manufacturer, holding them liable for failing to warn the proper risks in the generic drug labels.

This came after a generic drug label, terbutaline, failed to warn of its risks for pregnant women and led to deficiencies in fetal brain development.  Prosecutors claimed Novartis was responsible since generic drug companies must use the drug label provided by the brand-name counterpart, called Brethine.

Novartis claimed that they were not responsible as they did not manufacture the generic drug and additionally Brethine underwent a change of ownership.  Another company, aaiPharma Inc., bought rights to the brand-name drug in 2007, the same time when a pregnant woman was taking terbutaline.

The court countered that while Novartis owned the drug, it was their legal responsibility to update the label of its unwarned risks; in the case of both Brethine and terbutaline, its adverse effects relate to fetal brain development.

Moving forward, there are concerns that this liability for brand-name companies may affect their ability to innovate and may cause rising drug costs.  On the other hand, a branded drug companies will be motivated to develop new and safer labels for their drugs.

If you have any questions, please feel free to contact Focal Point Research Inc.  We are industry leading FDA and Drug Regulatory Consultants that you can trust to help guide your company in the right direction.