Profits Over Patient Safety: Metoclopramide and Big Pharma

Peter Wetherall

Contributor

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As readers know, Reglan (the name brand) is also dispensedas Metoclopramide. Reglan wasWyeth and Schwarz Pharma’s product. But these two giant pharmaceutical companies aren’t the only companiesthat make this dangerous drug. Generic companies make the generic form,metoclopramide. One of the largestgeneric pharmaceutical companies is Teva. Click here to see a list of their holdings on the SEC website.

Teva is a pharmaceutical manufacturerlocated in North Wales, Pennsylvania, which manufactures and markets a genericform of the drug metoclopramide.

Teva’spredecessor first received approval of an ANDA for metoclopramide in or about1985. In order forTEVA Pharmaceuticals USA to become an ANDA holder for metoclopramide (genericterm for Reglan, which was initially made by AH Robins Company [Wyeth]) – TEVAhad to submit their own ANDA or acquire the rights to an ANDA application thatwas approved for another company. TEVA acquired the ANDA approved application that was owned by Biocraft,which obtained FDA approval for its ANDA of metoclopramide in 1985. TEVA obtained the rights to that ANDAin 1996. At that time TEVA alsoobtained the documents that Biocraft generated or collected concerning itsapplication for an ANDA for metoclopramide. When Teva bought the rights to metoclopramide from Biocraftthere was plenty of scientific literature documenting the problems withmetoclopramide. Did Teva doits due diligence? Did Teva checkout this problematic drug?

Today, Teva continues to marketmetoclopramide. Their label isstill the same as it was 20 years ago despite all that we know about theproblems with metoclopramide. Evidence of profits over patient safety?