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March 25, 2013

Purdue medication safety expert discusses generic drug Supreme Court case

WEST LAFAYETTE, Ind. — A Purdue University medication safety expert says a U.S. Supreme Court case about the liability of generic drug manufacturers could increase the cost of medications and lead to drug shortages.

"All drugs, regardless of if they are brand name or generic, come with certain risks, and it is important that patients discuss the benefits and risks of taking a medication with their physician and pharmacist," said John B. Hertig, associate director for the Purdue College of Pharmacy's Center for Medication Safety Advancement. "It is a tragedy when someone is hurt by a reaction to, or side effect of, a medication, and we never want to see that happen. It also is tragic if someone cannot afford or doesn't have access to a needed medication or treatment. There is no easy solution to the issues raised by this case."

The Supreme Court heard arguments March 19 in Mutual Pharmaceutical v. Bartlett, a case in which a pharmaceutical company is seeking to overturn a $21 million jury award using a 2011 Supreme Court decision that limited the liability of generic drug manufacturers.

Approximately 80 percent of U.S. prescriptions are filled with generic drugs, which typically cost four times less than brand-name counterparts, Hertig said.

"One concern if the decision in this case places liability on the generic drug companies is that these companies may stop manufacturing drugs that carry a risk of certain side effects," Hertig said. "Patients may then only have access to a more expensive brand name drug, and there could be shortages if the manufacturer cannot keep up with the demand."

The generic forms are cheaper and can quickly be brought to market because they are able to "piggyback" on the work done by the brand-name drug's manufacturer. No lengthy testing and drug-approval process is needed for generic drugs if manufacturers can prove that the drug is equivalent to its brand-name counterpart, he said. However, federal law requires generic drug manufacturers to use the same labels as their brand-name equivalent.

In the 2011 case, the court decided that generic drug manufacturers cannot be sued for failure to provide adequate label warnings about potential side effects because of this requirement. This means that if an unlisted or inadequately explained side effect arises, someone taking the brand name drug could make a claim against the manufacturer, while someone taking the generic equivalent could not.

In the current case, Mutual Pharmaceutical argues that federal law also bars design defect claims because the drug's design also must match that of the brand-name counterpart.

"Patients, doctors and pharmacists must work together so that the patient makes the best and most informed choice about his or her treatment options," Hertig said. "In light of this case, a patient may want to know whether the drug being prescribed or administered is brand name or generic, not just for cost considerations, but also for the legal ramifications."

The faculty and staff of the Purdue University College of Pharmacy's Center for Medication Safety Advancement work with health professionals, students, and lawmakers to improve the systems that surround medication use.

Writer: Elizabeth K. Gardner, 765-494-2081, ekgardner@purdue.edu

Source: John B. Hertig, 317-275-6085, jhertig@purdue.edu