The US Food and Drug Administration (FDA) has written to global clinical network giant LabCorp to warn the company it is violating the law on a number of counts by selling its ovarian cancer test OvaSure. There was no suggestion that there was something clinically wrong with the test.
In the letter the FDA warned David P King, LabCorp president and CEO, that his firm was in serious violation of the Food, Drug, and Cosmetic Act involving the illegal marketing of the OvaSure test. The agency said because LabCorp did not seek marketing clearance or approval from the FDA, marketing OvaSure was against the law. The agency also informed the company that the product was misbranded under another section of the Act, and that the firm was in breach of several other violations such as failing to inform of its intention to “introduce the device into commercial distribution”.
Laboratory Corporation of America Holdings (LabCorp) is one of the largest networks of clinical laboratories in the world. The company has 36 primary laboratories in the United States and headquarters in Burlington, North Carolina.
The letter informed King that the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) reviewed LabCorp’s website information, press release, technical bulletin, and information given by LabCorp at a meeting with the FDA on 5th September about the OvaSure test, and found “serious regulatory problems involving these devices manufactured by your firm”.
The FDA asked that the firm promptly correct these violations or it will start to take regulatory action. LabCorp has 15 days to respond in writing.
The FDA wrote that based on the information collected it appeared that the ovarian cancer test was designed, developed, and tested by Yale University and not LabCorp. The instructions for using the product appear to have been written by Yale investigators, and certain materials and manufacturing processes follow specifications produced by workers at Yale.
The letter said:
“This device is not within the scope of laboratory developed tests over which the agency has traditionally exercised enforcement discretion.”
The FDA said it had not necessarily listed all “deficiencies associated with your devices” and reminded King that it was his firm’s responsibility to investigate and review all materials and make sure they complied with the regulations.
The agency said the firm should now take these violations promptly and if they failed to do so the FDA may proceed with regulatory action, without further notice. The actions may also include informing other federal agencies, including some who have direct purchasing influence over the product because they are involved in awarding government contracts (presumably for medical supplies, although this is not spelled out in the letter).
Source: FDA.
Written by: Catharine Paddock, PhD.