Abbott Laboratories Friday said federal regulators requested yet another 30 days to review manufacturing processes at a Lake County plant, a development that again delays the return of key diagnostic products to market.
Abbott said it now may not know until mid to late May whether the Food and Drug Administration believes the company has taken adequate measures to correct various manufacturing deficiencies at its Lake County diagnostics plant. Without FDA approval, the products–which generate about $250 million in annual sales–cannot be marketed.
Abbott said earlier this week that it hoped to get a green light from the FDA within two weeks.
Still, Abbott said Friday that the new timeline does not change its previous earnings guidance for the second quarter or full year 2002. “We have previously stated that the bulk of returned product sales were planned for the third and fourth quarter,” Abbott spokesman Don Braakman said.
As part of a consent decree Abbott signed in November 1999 to resolve the matter, the company agreed to pay a $100 million settlement to the FDA and to correct the deficiencies. The agency said Abbott violated quality assurance guidelines at its Lake County plant, where it makes diagnostic kits to test for various conditions including hepatitis, cancer and cardiovascular disease.
The FDA’s review has lasted longer than expected.
Despite the latest extension, analysts did not seem concerned.
“I guess the lesson is that when the FDA puts you in the penalty box, you don’t get out so fast,” said Kenneth Abramowitz, analyst with the Carlyle Group in New York. “Whether they are one or two months late is not particularly tragic. Given Abbott’s resources, they are clearly going to invest whatever they have to to make sure they are in compliance.”
Abbott shares declined 13 cents Friday to close at $53.69.
