Healthy Skepticism Library item: 4392

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Judge seeks FDA ruling on Novartis drug: report
Reuters 2006 Apr 17
http://biz.yahoo.com/rb/060417/novartis_pfizer.html?.v=1

Notes:

Ralph Faggotter’s Comments:

“The agency for several years has said it was close to issuing such guidelines, but has failed to deliver them.”

It seems a bit extreme when you have to sue a government department to stimulate them into active deliberation mode!

What is going on behind the scenes here? It doesn’t sound like a level playing field.

Full text: Reuters Judge seeks FDA ruling on Novartis drug: report Monday April 17, 6:39 am ET

NEW YORK (Reuters) – A federal judge has ordered the U.S. Food and Drug Administration to decide after a long delay whether Novartis AG can market a version of human growth hormone similar to one already sold by Pfizer Inc. (NYSE:PFE – News), The Wall Street Journal said on Monday.

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The order on Monday by Judge Ricardo Urbina of the U.S. District Court for the District of Columbia could put pressure on the FDA to come up with guidelines for approving generic copies of biotechnology drugs, the report said.

The agency for several years has said it was close to issuing such guidelines, but has failed to deliver them.

Sandoz, the generics arm of Novartis (NOVN.VX) (NOVN.VX), sued the FDA last September for leaving its copycat product in limbo, a move designed to break a logjam over so-called biogenerics.

The FDA in November sought a dismissal of the U.S. lawsuit, saying the charges were unfounded since its experts had not finished their review of the Novartis drug, called Omnitrope.

Officials at Novartis and Pfizer were not immediately available for comment.

The FDA has not yet approved any generic, or “biosimilar,” forms of biotech drugs even though expensive biotech medicines are quickly becoming favored treatments for a range of diseases, including cancer and arthritis.

Unlike conventional “small molecule” medicines that are synthetic compounds, biotech drugs are difficult-to-make forms of naturally occurring proteins.