Allergan Cited Over Eye-Product Marketing

Federal regulators have cited Allergan Inc. for misleading customers in marketing its anti-infection eye product, Ocuflox.

In a May 30 letter, the Food and Drug Administration notified the Irvine-based drug company that it had violated the law by using data from test-tube experiments, rather than human tests, in promotional materials to suggest that Ocuflox kills more bacteria than competing products.

The agency demanded that the company quit circulating both a sales brochure and letter to physicians that referred to the test-tube results.

“The big issue was that [Allergan] claimed effectiveness by using data on how the drug works in the test tube. That does not always correlate with how it may work in the human eye or the human body,” said Tom Abrams, the agency official in charge of overseeing drug marketing. “They tried to use the lab data to say that theirs was superior to other drugs,” he said. “It’s a comparative claim without adequate evidence to support it.”

Dave Garbe, Allergan’s director of scientific information and medical compliance, said Monday that the materials do not violate the law and that they repeatedly point out that the data resulted from lab tests.

Abrams said it will evaluate Allergan’s response to see whether the company makes a good case for continuing to use the materials.

Abrams said his division each year issues hundreds of such notices of marketing violations to drug companies and that in virtually all cases the agency and the companies work out their differences.

Allergan stock closed down 25 cents a share at $32.375 in New York Stock Exchange trading Monday.