Replies to post #116404 on Biotech Values

[jq1234]

Thyrogen was not considered medically necessary by the FDA and therefore it was a surprise that GENZ were not ordered to halt shipments.

http://www.businesswire.com/news/home/20100524006520/en/Genzyme-Announces-Final-Terms-FDA-Consent-Decree

In the United States, distribution of Thyrogen will be based on medical necessity until product filled and finished at another facility is available. The FDA has developed a Dear Healthcare Provider letter describing the patients for whom FDA considers Thyrogen to be medically necessary. This letter will be included in shipments of Thyrogen that are filled and finished in Allston.