The United States Food and Drug Administration issued a letter to LabCorp warning them that they are in violation of the law. LabCorp doing illegal things brings up their checkered past, when they were charged with fraud in the LabScam investigation.

The FDA warning letter and possible criminal and civil action against LabCorp could be the beginning of the end for Laboratory Corporation of America. I say this because as one government agency moves against them, there are possibly other government agencies that might step up to further investigate other allegations against the company. It’s about time that this regulatory oversight process start. For too long LabCorp has focused on the buck as opposed to the law and the required quality standards. In my own opinion, it is a company that is out of control.

Here’s the FDA story:

WASHINGTON, Oct 8 (Reuters) - Laboratory Corp of America (LH.N: Quote, Profile, Research, Stock Buzz) is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday.

The OvaSure test does not fall in a category that can be sold without prior clearance from the agency, the Food and Drug Administration said.

“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the agency said in a letter dated Sept. 29.

The agency told the company to “take prompt action to correct these violations.”

LabCorp spokesman Eric Lindblom said the company was “disappointed” by the letter.

“We are currently in discussions with the FDA over the next steps and of course we share the FDA’s determination to assure patients are protected,” he said.

The company started selling the blood test in June, saying it could detect early-stage ovarian cancer in high-risk women.

The FDA letter was posted on the FDA website. You can read the full letter by clicking here.

LabCorp shares (NYSE: LH) fell nearly 1.8 percent today to close at $60.63 on the New York Stock Exchange.

This is a recent article about LabCorp and their practices. The United States Food and Drug Administration believes that LabCorp’s testing “…may harm the public health.” Shame on you LabCorp for putting money before patient’s health.

The US Food and Drug Administration is looking more closely at an ovarian cancer test from Laboratory Corporation of America after deciding that the existing data did not support the test’s commercial use.

 

The FDA Office of In Vitro Device Evaluation and Safety has asked Labcorp to discuss with the agency the utility of its OvaSure Yale test, after it learned that the performance characteristics of the test were based on research that is not representative of the intended pool of patients.

 

In a letter to Labcorp dated August 7, OIVD Director Steve Gutman wrote that the scientific community would not view the study as sufficient to establish performance characteristics for high-risk women who may have ovarian cancer.

 

“Based on our review of your promotional materials and the research,” Gutman wrote, “… we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health.” Gutman told Labcorp that OIVD would like to talk to the company about offering the test, and any other strategies the company may have for validating the test.

I’ve received dozens of emails related to problems and complaints against LabCorp. From those who have filed lawsuits against them to physicians that are fed up with service related issues. I will respond to them all this week. Since this is something that I do on the side because of the poor attitude of LabCorp company manager and executives, I can only do it during down time. Sorry about that.

The retail business has many dynamics. It’s a business that I know well. Relating these principles to LabCorp’s operation, it is hard to believe that there are so many patients that will never set foot in a LabCorp center again. Yet the company and its executives do not seem to be doing anything about it. It’s a real shame how a company can believe that they are so omnipotent that they can do whatever they want. Our country’s laws and regulations are established for these particular instances. They will eventually catch up to LabCorp. The government agencies will move in and that’s when you will see them change.

I also believe that the tough economy will severely affect LabCorp and their view of the customer. In my opinion, they see the customer as the HMO, insurance company or 3rd party payer. The patient is seen as a secondary factor when in fact it is all about the patient. Poor results or worst yet, no results, will not only anger the patients but also the payer as the patient will start complaining. Why do these managers and executives not see this? Oh well, they will when the 3rd party payers start cancelling contracts because of malpractice lawsuits. And the doctors that send them the specimens for results? They will eventually get tired of poor results that affect the lives of their patients. I believe that doctors generally care more about their patients than the lower prices offered by LabCorp. That will also work against LabCorp. When will this company wake up to reality?

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If you have billing issues with LabCorp, let everyone know.