Gliatech Inc. pleaded guilty Thursday to six misdemeanor charges for providing false or incomplete information to the Food and Drug Administration (news – web sites) about the biotechnology company’s main product, a back surgery gel.
U.S. District Magistrate Judge Jack B. Streepy gave the company the maximum $1.2 million fine for six violations of the Food, Drug and Cosmetic Act.
The gel in question, ADCON-L, reduces scarring after back surgery.
Gliatech received complaints from January 1999 to February 2000 from surgeons about adverse medical reactions suffered by patients who used the gel.
The company pleaded guilty to failing to report medical problems to the FDA within 30 days, and falsely representing test results to the FDA.
Gliatech has stopped selling the gel ADCON-L in the United States pending further FDA review.