Generic drug industry needs to stand up for patient safety

The Generic Pharmaceutical Assn. says a proposed federal regulation that would allow makers of generic drugs to inform people about all known health risks would create “dangerous confusion” and have “harmful consequences for patients.”

And why would that be?

For the answer, the industry group pointed me toward a recent report from Matrix Global Advisors, an independent consulting firm. The report says the rule change would needlessly complicate the market and add $4 billion a year to already bloated healthcare costs.

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“Higher insurance premiums, self-insurance costs and reserve spending on product liability will likely force generic drug manufacturers to raise prices,” said Alex Brill, the head of Matrix and the report’s author. “Generic manufacturers also may exit or decline to enter the market for products with greater liability risk.”

It’s not until you reach the last page of the Matrix report that you discover it was “sponsored” — that is, paid for — by the Generic Pharmaceutical Assn.


As my colleague David G. Savage reported last week, generic drug makers are pulling out all the stops to fight the Food and Drug Administration’s attempt to provide consumers with more information about the possible risks of prescription drugs.

One would think any move to improve drug safety would be welcomed by all concerned. After all, nobody wants a costly lawsuit related to misuse of a prescription med or an unforeseen side effect.

In this case, though, the $240-billion U.S. generic drug industry has long enjoyed different (read: looser) rules than those applied to brand-name drugs. And it likes things just as they are.

“They’ll fight anything that could add to their costs,” said Mindy Marks, a health economist at UC Riverside. “That’s why we have an FDA — to make sure consumers have enough information to make informed decisions about drugs.”

Makers of brand-name drugs have strict requirements about risk warnings. Just think about all those fast-talking voices at the end of commercials for everything from heart medications to pills that promise to make a man more of a man.

The same doesn’t apply to generic drugs, and you can thank the five conservative justices on the U.S. Supreme Court for that.

They decided in 2011 that generic-drug companies don’t share the same level of responsibility as makers of brand-name equivalents to update their warning labels when a new risk comes to light.

The conservative justices followed this bizarre ruling with an even stranger 5-4 decision last year. They said that because generic makers are just following brand-name makers in their use of ingredients, patients can’t sue them even if their product is found to be harmful.

In response, the FDA came up with a modest rule change that would help level the playing field. It would empower generic makers to update their warning labels any time new risks become known, rather than wait for federal authorities to require a change.

“More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date,” said Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

Seems reasonable enough.

Let’s say a big company makes baby cribs. And let’s say smaller companies manufacture copycat cribs.

If a potentially dangerous design flaw becomes known, you’d think all producers of these cribs have a responsibility to inform consumers. And, by the same token, you’d think all such companies are legally accountable for the products they sell.

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