This could be the year Abbott Laboratories finally puts the quality-control problems in its embattled U.S. diagnostics division to rest.
At least that’s the hope of Abbott’s top executives, who say they have intensified their efforts and hired additional outside consultants to satisfy terms of a punishing Food and Drug Administration consent decree.
The North Chicago-based maker of drugs and medical products has been unable to sell some 60 diagnostic tests in the U.S. since entering into the consent order with the FDA in 1999 over manufacturing deficiencies.
Among other concerns, the FDA has questioned validation processes designed to ensure that tests used in making the products are done the same way each time. The diagnostic kits in question are used by hospitals and large reference laboratories to test for everything from hepatitis and cancer to cardiovascular disease.
Although executives are offering no guarantees on when Abbott will solve the problems, they are optimistic they will have a “favorable resolution” by the end of this year, Rick Gonzalez, Abbott president and chief operating officer, medical products group, told Wall Street analysts during the company’s earnings conference call last week.
Gonzalez said Abbott has two consulting firms working with the company. They are AccuReg Bioregulatory & Compliance Associates of Plantation, Fla., which is assisting with the development and implementation of the compliance plan, and Bio-Reg Associates Inc. of Beltsville, Md., which is monitoring ongoing compliance initiatives, an Abbott spokesman said.
“Our regulatory consultants are conducting rolling audits,” Gonzalez said.
Meanwhile, Abbott’s U.S. diagnostics sales still suffer. Revenues slid 8.4 percent in the fourth quarter, to $278 million, the company said.
Northwestern Memorial Hospital may be able to break ground this spring on its proposed new Prentice Women’s Hospital after clearing a key state regulatory hurdle.
Last week, the Illinois Health Facilities Planning Board gave its approval for the construction permit for the new Prentice, which is projected to cost $451 million and is expected to open in 2007.
The 288-bed facility, which two years ago won state approval for its design plan, has been in the works for several years, with the existing 27-year-old women’s hospital at capacity. In the last two years, Prentice has had a 22 percent increase in baby deliveries, to 8,784 from 7,191.
The state’s approval “will allow us to build on the Prentice tradition of providing world-class obstetrics care, while offering a growing array of women’s health services beyond maternity in one state-of-the-art center,” said Ralph Weber, vice president of community relations for Northwestern Memorial.
Northwestern Memorial officials still need final approval from the city before deciding a specific date to begin construction.
The new Prentice will be built on the site where the Wesley Pavilion once stood, at North Fairbanks Court and East Superior Street, a block west of the existing women’s hospital.
