Genzyme Says F.D.A. Will Oversee Its Factory
By ANDREW POLLACK
Published: March 24, 2010
The Food and Drug Administration is preparing to fine the biotechnology giant Genzyme for recent manufacturing problems and take a greater role in overseeing operations at the company?s factory in Boston, the company said Wednesday.
Genzyme?s announcement indicates that federal regulators have, in effect, lost confidence in the company?s ability to run its factories without close supervision.
Genzyme, in a news release, said that the F.D.A.?s enforcement action would probably result in a consent decree, ?under which a third party would inspect and review the factory?s operations for an extended period and certify compliance with F.D.A regulations.?
Last June, Genzyme was forced to shut its factory, on the banks of the Charles River in the Allston neighborhood of Boston, because of viral contamination. That caused severe shortages, which still persist, of two of Genzyme?s biggest products, which are treatments for rare diseases: Cerezyme for Gaucher disease and Fabrazyme for Fabry disease. Each drug sells for tens of thousands of dollars a year.
Then in November, the F.D.A. said that Cerezyme, Fabrazyme and three other Genzyme drugs that are made in part at the factory were contaminated with particles of steel, rubber or fiber, potentially causing a risk for patients.
The manufacturing problems distressed patients, led to a fall in Genzyme?s sales and earnings and opened the door to competitors.
The issues also left the company vulnerable to a move by the billionaire investor Carl C. Icahn, who is trying to place himself and three associates on the company?s board. The legacy of Henri Termeer, the chief executive who has run the company for a quarter of a century, is in jeopardy.
The F.D.A. has entered into consent decrees with other pharmaceutical companies in the past for manufacturing issues. In 2002, Schering-Plough, which is now owned by Merck, paid $500 million to the government for repeated failure to remedy manufacturing problems involving dozens of drugs at four factories.
Genzyme, which had $4.5 billion in revenue last year, said it expected that shipments of Cerezyme, Fabrazyme and another drug, Myozyme, would continue uninterrupted during the period of the F.D.A.?s enforcement action. But it suggested that shipments of Thyrogen, a drug used by people with thyroid cancer, might be slowed.
?Genzyme will work cooperatively with the F.D.A. to restore the agency?s confidence in its ability to operate the Allston plant at the highest standards,? the company said in its news release. The company has already brought in new people to oversee manufacturing and quality control.