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A federal district court ruled that FDA cannot fail to rule on a Sandoz's application for approval of omnitrope, a human growth hormone, just because it has no policy for generic biologics. Court watchers say the decision may help other generic biologics move forward in the approvals process.
A federal judge has ordered FDA to make a decision on whether to approve a generic version of human growth hormone.
In 2003 Sandoz, the generics manufacturing arm of Novartis AG, filed for approval of omnitrope, a generic version of Pfizer´s human growth hormone product Genotropin, which was approved in 1995. In 2004, the agency said that, though there was nothing wrong with the application, it could not take action on it. Sandoz filed suit in US District Court for the District of Columbia, arguing that FDA had a statutory obligation to act, pointing to the 180-day deadline imposed by the Prescription Drug Users Fee Act (PDUFA).
"This is the first time courts have held FDA to statutory deadlines," explains William Schultz of the law firm Zuckerman Spaeder. Schultz goes on to say that the decision doesn´t mean that any company that fails to get a decision within a PDUFA deadline will have a valid lawsuit. The courts have declined lawsuits of this sort when FDA shows that the delay was a matter of insufficient resources. What makes this case different is that resources weren´t the issue. It was that FDA did not have a policy for a category of drugs.
"The issue of designing some mechanism to facilitate the entry of generic biologics is quite important," says James Love, director of the public-interest Consumer Project on Technology, which tracks issues related to intellectual property. "It´s bad enough that FDA is really slow on processing some of the data on regular generics, where there´s a very well-defined procedure. But biologics are becoming much more important and incredibly aggressively priced."
Sandoz´s omnitrope was approved for marketing in the European Union on April 20. It willl be marketed first in Germany and Austria. The European Medicine´s Agency´s (EMEA) Committee on Medicinal Products for Human Use has already given a positive recommendation for another human growth hormone, Valtropin (somatropin) by Biopartners GmbH, based on Lilly´s Humatrope.
The EMEA has also released guidance for the approval of generic recombinant insulin, somatropin, erythropoietin, and recombinant granulocytic colony stimulating factor (rG-CSF).
To Zuckerman, the decision may empower people at FDA who want to move ahead on generic biologics. "Once FDA starts down this road [of having to make a decision], they will not be able to do just nothing." Andrea Hofelich of the Generic Pharmaceutical Association added, "We´ve been calling for FDA to move forward with guidelines and certainly think FDA has the ability to approve them currently. We would like to see things move forward."