generic brand drugsIntroduction

Generic drugs become available once a patent expires on a branded drug, which, in the US, is generally 20 years. Generic drugs account for more than 80% of all prescriptions in the US, and since generic drug manufacturers do not incur the same costs as the company that originally marketed the drug, generic drugs are typically sold for substantially lower prices than the “identical” branded drug. In addition, state laws allow pharmacists to automatically substitute a prescription with a generic version even if the doctor prescribed a brand name drug. While generic drugs are supposed to be identical to brand name drugs, what happens when something goes wrong with the generic drug? Is it acceptable to sue the brand name maker?

Background

According to the FDA, when a generic drug is submitted for approval by a sponsor, the drug is required to have the same active ingredient (inactive ingredients may vary), strength, dosage form, and route of administration as the brand name. In addition, generic drugs must perform “approximately” the same in the body as the brand name drug and be used for the same indications. A slight level of normal variability is permitted, but inactive ingredients and manufacturing processes may vary. While generic drug labels are required by law to be identical to the labels of their brand name competitors, generic drug companies are not required to conduct extensive preclinical and clinical studies on their generic copies, and this can result in an incomplete safety profile. Inactive ingredients contained in the generic “copy” may cause different adverse effects on people that the branded drug does not.

Issue

Should branded drug makers be held liable for generic copies claimed to cause harm to patients?

 Rule

Branded manufacturers should be held liable for generic drugs claimed to cause harm to patients if:

  1. the generic versions are truly bioequivalent to the branded drug and safety is established

OR

  1. the branded manufacturer does not include the known side effects on their label

Analysis

Just how identical are generic drugs to their branded version? An independent review conducted by ConsumerLab on Wellbutrin vs. generic bupropion found that the generic version was indeed NOT therapeutically identical to the branded drug. In addition, the FDA also conducted a bioequivalence study comparing the 2 drugs and also found that the generic version failed to act in the body in the same manner as the branded drug; therefore, it is not bioequivalent. As a result of numerous reports to the FDA, the drugs were removed from the market.

A systematic review published in the Journal of the American Medical Association reviewed 47 articles (38 randomized–controlled trials) that studied cardiovascular medications and the clinical equivalence between generic copies. Results of the review indicated that the majority (53%) of the reports expressed a negative view of generic substitution.

Several lawsuits have been brought against generic drug manufacturers over the last few years for complaints regarding the safety of generic drugs. Many of these cases are being dismissed due to a Supreme Court decision made in 2011 stating that the generic drug companies did not have control over their labels and therefore cannot be sued for not alerting patients to the risks involved while taking these drugs. This case has set the precedent for allowing generic companies to “get away” with marketing drugs that may not be safe.

To make matters worse, in January 2013, the Alabama Supreme Court ruled that Pfizer was to be held liable for a generic copy of its drug, Reglan, that is claimed to have caused harm to patients. Although this case is set for a rehearing, the ruling was not good for branded drug makers. According to the President of the American Association of Justice, “It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers–not generics–can be held accountable for their drugs’ dangerous side-effects.” In addition, in the case against Pfizer, the branded label clearly states the risks involved with taking the drug, including the adverse event in question.

Conclusion

Since inactive ingredients of a generic drug may differ and be of lower quality than that of a branded drug and, subsequently, clinical trials conducted by generic manufacturers are not required to establish the safety and efficacy of generics copies, there is no way to really determine that the generic copy is made the same way or is “identical” to the brand name drug. Therefore, the brand name company should not be held liable for claims made against it.

In addition, using the case against Pfizer, since the branded label clearly states the risks involved with taking the drug including the adverse event in question, the branded manufacturer should not be held liable for a drug that they did not manufacture and market.

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