Patients Taking Generic Drugs Need More Protection

In a recent ruling issued by the U.S. Supreme Court, generic drug companies are not responsible for insufficient warnings to patients regarding the potential dangerous side effects associated with the use of their products, provided that their packaging labels are identical to those of the brand name medications they duplicate.

The ruling provides no real answer or guidance as to how generic drug companies are to properly fulfill their responsibility to provide consumers and providers with accurate warning labels for their products. However, the ruling could prompt lawmakers in Washington to craft swift changes to current legislation, as Congress and the FDA both retain the authority to alter regulations if they so desire.

For example, the makers of generic drugs are currently unable to have direct access to the clinical-trial and post-approval data that makers of brand-name drugs use to craft product warnings. Increasing the transparency of this process could open the lines of communication between the FDA, generic drug companies, and their brand-name counterparts. This type of transparent communication would allow all product warning labels to reflect the most current and comprehensive information available.

Without legislative reform, the Supreme Court’s ruling leaves patients taking generic drugs extremely vulnerable, subjecting them to a bizarre statutory process. Also, the consumer’s right to sue over inadequate warnings is ultimately based on sheer chance, depending on whether or not their pharmacist filled their prescription with a brand-name drug or a generic. The patient using the brand-name medication still has the ability to sue the manufacturer over inadequate warnings, while the patient taking the generic cannot. This fact is especially alarming, considering that approximately 75 percent of prescriptions are filled with generics, as opposed to brand-name products.

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