Genzyme confirms details of consent decree and $175m fine
pharmafile | May 27, 2010 | News story | Manufacturing and Production |Â Â Cerezyme, Fabrazyme, Genzyme, Lumizyme, Thyrogen, manufacturing complianceÂ
Genzyme’s predictions on the penalties levied for the ongoing problems at its manufacturing facility in Allston Landing have been confirmed, with the Food and Drug Administration fining the company $175 million and setting time limits on the transfer of production from the site.
Last month, Genzyme said it had already accounted for the fine – resulting from what the FDA describes as “unlawful profits” – in its first-quarter results.
Genzyme has been struggling to correct quality deficiencies at its Allston Landing plant, which have led to shortages of medicines including Gaucher disease treatment Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta) for Fabry disease and Thyrogen (thyrotropin alfa for injection).
At the moment, Cerezyme is still being shipped at just 50% of demand while Fabrazyme is currently running at 30% of demand.
The FDA’s consent decree also sets a deadline for the transfer of fill and finish activities at Allston Landing to other facilities, and if this is not met the firm will forfeit 18.5% of any revenues from products made at the troubled plant.
For the time being Cerezyme and Fabrazyme will continue to ship from Allston Landing, although the FDA says that by 28 November, filling and finishing of product destined to for US sale must be shifted to other plants. For international sales the deadline is 31 August 2011.
Thyrogen that is filled and finished at Allston Landing will only be shipped in cases of “medical necessity” until production is transferred to another facility, according to Genzyme. A letter to healthcare providers will be included in all packs finished at the plant to explain what is meant by medical necessity.
Genzyme will also be required to submit a timeline for completing a remediation plan drafted last year to improve quality and compliance at its Allston facility, a process which could take two to three years to complete. The process is being assisted and overseen by Quantic, a consultancy and auditing company.
If it fails to meet the timeline targets, Genzyme faces fines of up to $15,000 per day for each drug product still affected by non-compliance. And once the remediation programme is completed, the FDA will require five years of oversight and annual reports submitted by Quantic.
Phil Taylor
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