Massachusettsâ€™ drug manufacturing plant, relinquishing $175 million to the federal government, said the U.S. Food and Drug Administration (FDA).
The consent degree agrees to correct <"https://www.yourlawyer.com/practice_areas/defective_drugs">manufacturing quality violations at its Allston manufacturing facility; the $175 million represents unlawful profits from the sale of products made at the plant. Under the consent decree of permanent injunction, Allston also agreed to adhere to a strict timetable to bring the plant in line with the FDAâ€™s regulatory requirements. The paymentâ€”known as a disgorgementâ€”involves the company giving up profits obtained by improper or illegal acts.
The decree was agreed to by Genzyme; Genzyme Chief Executive Officer, Henri A. Termeer; Genzyme Senior Vice President for Manufacturing Sciences and Technical Operations, W. Blair Okita; Genzyme Senior Vice President for Global Product Quality, Ronald Branning. The decree was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010 and is subject to court approval.
Genzyme is a sole supplier of several enzyme replacement drugs for injection that are used to treat rare genetic disorders. During an inspection of the Allston plant from October 8, 2009, until November 13, 2009, FDA inspectors found Genzymeâ€™s systems for ensuring manufacturing quality were inadequate, resulting in production delays; critical shortages of medically necessary products to consumers; and drugs contaminated with metal, fiber, rubber, and glass particles. These problems violated the FDAâ€™s regulations for manufacturing practice. Genzyme also temporarily suspended manufacturing of some products due to a viral contamination in a bioreactor that makes bulk amounts of its drugs. This resulted in additional drug shortages.
â€œIt is critical for the safety of the drug supply that companies comply with basic manufacturing standards. FDA takes these obligations very seriously and expects manufacturers to do the same,â€ said Joshua Sharfstein, M.D., FDA principal deputy commissioner.
Cerezyme, Fabrazyme, Myozyme, and Thyrogen are drug products that undergo all or some stage of manufacture at the Allston plant. Cerezyme treats Gaucherâ€™s disease, which causes fatty substances to accumulate in the liver, spleen, and other organs. Fabrazyme treats Fabry disease, which prevents the body from breaking down oils and fats that build up in the eyes and kidneys. Myozyme treats Pompe disease, a muscular disorder. Thyrogen is used to diagnose thyroid cancer.
BizJournals pointed out that the enforcement and remediation actions will lead to a drug shortage for Genzyme of Thyrogen and that the FDA has written to health care providers about the issue. The FDA wrote that it will limit Thyrogen to specific patients most in need of the medication until Genzyme either corrects its manufacturing problems or transfers specific procedures said BizJournals. The FDA developed criteria to identify critical need patientsâ€”those with a high risk of cancer recurrence or for side effects associated with withdrawing treatmentâ€”said BizJournals. The problem should not impact children, said BizJournals, because the FDA determined that Thyrogen is not considered medically necessary for this group since children are, â€œmore likely to tolerate a short period of hypothyroidism.â€
Genzyme also just released a supply update on Cerezyme, saying it expects to ship at 50 percent of demand through the June/July and expects shipments of Fabrazyme to continue at 30 percent of demand through the third quarter of 2010, said BizJournals.