Lovenox Labors Lost

  • by: |
  • 08/12/2009
A few years ago I met Israel Markov, the "Big Abba" of Teva.  A memorable guy for a lot of reasons.  One of those reasons was his blunt Sabra honesty.  One thing he said to me was that "Teva isn't in the pharmaceutical business.  We are in the litigtation business."

It seems now that another company, Amphastar Pharmaceuticals, isn't satisfied with patent litigation as its weapon of choice.  Unsatisfied with the way the FDA is dealing with their file for generic Lovenox, they've achieved new lows by attempting personal intimidation tactics.  It won't work.

They're slinging mud.  It will only come back to splatter on their own reputation.  

Amphastar claims that its rival, Momenta,  has a "leg up" and is getting "special access."  And yet both companies are in the same place in the regulatory process and both companies are being asked for the same data sets.  And this is unfair why?

According to Amphastar it's unfair because CDER Director, Dr. Janet Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.

Talk about desperate measures.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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