A couple weeks ago, Genzyme informed its Fabry patients again that it had had a manufacturing failure with a newly made lot of Fabrazyme. The company said that this would cause further delays in making the product fully available to patients - who would again have to ration reduced doses of the life-saving drug.
Patients Try Again To Break Genzyme Drug Patent // Pharmalot.
Today, it's been reported on Pharmalot blog that a patient group is again asking the NIH to allow march-in rights that would give another manufacturer a shot at making the drug. The argument is that since the underlying patents for Fabrazyme were federally funded - then the Bayh-Dole Act provides that patient access to the patents can't be banned just because Genzyme is unable to produce.
Previously, NIH turned down a similar petition earlier this year saying that it was unlikely a firm could come in and produce the drug in the short-term to help the petitioning (or other) patients. Now Genzyme has failed again.
The plaintiffs attorney had this to say,
It would be unconscionable to refuse march-in at this point. Genzyme has caused three recent drug shortages...After nine consecutive false promises to patients, investors, and, now, the NIH, there is no reason to believe that Genzyme will ever be able to properly supply drug to Fabry patients. After what these Fabry patients have had to endure, they deserve a reliable drug supply, which the NIH has the power to grant.
Let's hope that Shire reactivates its application with the FDA for Replagel. That would appear to be the fastest option open to this patient group.
Posted by Bruce Lehr April 5th 2011.
More from the Patent Doc blog (April 11th) that I post for completeness sake
http://www.patentdocs.org/2011/04/fabry-patients-request-rehearing-of-nih-march-in-request-for-genzymes-fabrazyme-patents.html
Posted by: bigredbruce | 04/11/2011 at 02:52 PM