Generic drug industry needs to stand up for patient safety

The FDA is applying that reasoning to the prescription-drug industry. If a company offers a drug to consumers, whether as a brand-name or a generic version, it must stand behind the safety of that drug.

Yet the generic-drug industry says this would end the availability of relatively cheap alternatives to brand-name medications and cause irreparable harm to the healthcare market.

Ralph Neas, president of the Generic Pharmaceutical Assn., told me that his group doesn't want to kill an overhaul of the labeling rules. It just wants to improve them.

"The rule change, as it's written now, isn't based on science," he said. "It's based on politics."

A better approach, Neas said, would be for the FDA to study and approve all notification changes in advance.

This would prevent different makers of generic drugs from introducing different warning labels, which Neas said would only confuse people.

"What you don't want is a situation that could jeopardize patient safety," he said.

The industry's approach would have the added benefit of shielding generic makers from costly lawsuits because there'd be no expectation of them acting independently, in a timely fashion, to get the word out on health risks.

Makers of generic drugs could instead sit back and let the FDA do all the deciding — a process that now takes months if not years.

Edward Norton, a healthcare economist at the University of Michigan, said he could understand the industry's point of view. No company wants added costs and responsibilities.

"But I don't understand why there's a difference between brand-name drugs and generic drugs," Norton said. "The fact that most drugs sold in this country are generics but don't have the same requirements for warnings makes no sense."

Seems to me that if you're in the prescription drug business, whether as a maker of brand-name or generic medicines, you have exceptionally high standards to meet in terms of safety and safe usage.

The idea that the generic drug industry feels it shouldn't be as accountable as other drug companies is simply ridiculous — and wildly irresponsible.

Kind of like basing your case on an "independent" report that you paid for.

David Lazarus' column runs Tuesdays and Fridays. He also can be seen daily on KTLA-TV Channel 5 and followed on Twitter @Davidlaz. Send your tips or feedback to

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