Genzyme Hit With FDA Warning LetterMar 12, 2009 | Parker Waichman LLP
Biotech giant, Genzyme Corporation, has received a warning letter over what federal regulators are describing as “significant objectionable conditions” at its Boston manufacturing plant, reports the Boston Business Journal. The conditions were so problematic that the regulators are threatening to withhold drug shipment approvals until Genzyme cleans up its act. Genzyme is located at 500 Soldiers Field Road in Allston.
The U.S. Food and Drug Administration (FDA) detailed its findings in a warning letter dated February 27 that was addressed to Genzyme’s CEO Henry Termeer, said the Boston Business Journal. The FDA had conducted a routine, nearly month-long, inspection that began September 15 and concluded on October 10, which found “significant deviations from current good manufacturing” practices, most specifically concerning enzyme-replacement therapies Fabrazyme and Cerezyme and Pompe treatment, Myozyme, said the Boston Business Journal.
Pompe Disease is an autosomal recessive genetic disorder that causes lysosomal glycogen accumulation in multiple tissues, with cardiac and skeletal muscle tissues most seriously affected. Genzyme manufactures a drug that treats the rare disease, said the Boston Herald, which explained that there are two “publicly available” versions of the medication that are currently sold under the name Myozyme. One version is sold in the United States and the other version is available in Europe. Lumizyme—a third version—is not yet available.
Genzyme recently confirmed that it may experience delays in bringing the third drug to market, in part because of the FDA’s warning letter as well as the various issues raised concerning its inspection, according to the Boston Herald.
The Boston Herald reported that FDA inspectors discovered issues with equipment maintenance and also expressed concerned about Genzyme’s outdated computer system. The inspection also revealed that there are problems with production controls and contamination procedures, said the Boston Herald.
Although Genzyme has responded twice to the FDA’s concerns, it must enter into full compliance in order for the plant to remain in operation. "Failure to promptly correct these deviations may result in further regulatory action without further notice. Such actions may include license suspension and/or revocation, seizure, or injunction," said the FDA in its letter to Genzyme, according to the Boston Business Journal
This means that marketing approval will not be granted by the FDA for Genzyme’s drug Lumizyme until the firm appropriately addresses all of the FDA’s concerns about the plant’s manufacturing practices, said the Boston Herald.
Genzyme said it is working to correct the issues raised in the FDA warning letter and is expecting to resolve all of the problems and open issues within the next three to six months, reported the Boston Herald. “We take this matter very seriously,” said spokeswoman Lori Gorski via an emailed statement. Gorski added, said the Boston Herald, that, “One week after we received the warning letter, we submitted 1,600 pages of study reports and procedural documents for FDA review.”
According to the Boston Herald, the FDA’s February 27 warning letter to Genzyme was released following a request from the Wall Street Journal.