Republicans Prod Califf on Heparin Findings

Republican leaders of the House Energy and Commerce Committee say that even with intensified FDA efforts to protect heparin, “serious challenges remain to significantly reduce risks for heparin from economically-motivated adulteration.” In a 3/29 letter to FDA commissioner Robert Califf, the congressmen lay out five key problems identified during the committee’s probe of the 2007-2008 heparin contamination crisis:
         various FDA offices failed to share key investigative information with each other related to heparin contamination;         FDA was not responsive to credible evidence of heparin contamination with non-porcine material before the heparin crisis, and for several years in the immediate aftermath of the crisis;         FDA investigations and inspection strategy did not follow up on concerns about the possible recycling of overly sulfated chondroitin sulfate-contaminated heparin;        FDA’s oversight approach to Chinese heparin firms did not fully take into account ongoing market conditions in the Chinese heparin industry; and         FDA’s lengthy open criminal investigation into an aspect of heparin contamination suggests difficulties and challenges in enforcement against criminal economic adulteration.

The letter says that due to these five concerns the committee would like to be provided the following information and documents:
        actions the agency is taking or has taken to improve internal communication and coordination of FDA investigative and inspection activities related to economically-motivated adulteration;        whether FDA monitors the Chinese pharmacopeia;         whether FDA will ask its Chinese counterparts why their government recently changed its position on overly sulfated chondroitin sulfate in heparin and whether it would be willing to work with FDA to prevent heparin contamination;         whether FDA investigated to determine if overly sulfated chondroitin sulfate removal was taking place in China and how the agency knows whether previously contaminated crude heparin from China was not recycled and imported into the U.S.;        a list of Chinese drug firms or suppliers inspected by FDA since 1/2013 with copies of the inspection reports;        whether the criteria for agency risk assessment for prioritizing drug inspections in China include which drugs are at highest risk of economic adulteration;         the accomplishments of FDA’s Working Group on Economically Adulteration that first met 9/23/11; and         how FDA investigations of economically-motivated adulteration could be improved.