WASHINGTON, DC - As part of the committee’s ongoing investigation into the 2007-2008 heparin contamination crisis, Republican Energy and Commerce Committee leaders this week sent a letter to newly confirmed U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf. The letter was signed by full committee Chairman Fred Upton (R-MI), Chairman Emeritus Joe Barton (R-TX), Health Subcommittee Chairman Joseph Pitts (R-PA), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), and Commerce, Manufacturing, and Trade Subcommittee Chairman Michael C. Burgess, M.D. (R-TX).
In the letter to Commissioner Califf, the committee leaders write, “In late 2007 and the first months of 2008, dozens of patients throughout the United States experienced allergic-type reactions from heparin sold by Baxter International. Several patients died and numerous patients suffered severe allergic-type reactions. Baxter heparin was soon recalled and then came off the market. … (S)cientific evidence obtained by FDA, other authorities, researchers, and industry showed that the reactions were linked to a contaminant, overly sulfated chondroitin sulfate, or OSCS, that was intentionally introduced in China during the crude heparin manufacturing process. The contaminant was man-made, not a natural impurity."
The leaders continued, “Although the perpetrators’ identities of the heparin contamination and their methods have remained unsolved for more than seven years, the concerns identified in the committee’s investigation have broad implications for the FDA’s approach to addressing economically-motivated adulteration, particularly as it relates to imported drug products from China. For heparin, FDA relies on tests to detect contaminants and more inspections to protect the U.S. heparin supply. However, even with these intensified efforts to protect heparin, serious challenges remain to significantly reduce risks for heparin from economically-motivated adulteration."
The letter identifies five key problems identified during the committee’s ongoing investigation:
* Different FDA offices failed to share key investigative information with each other related to heparin contamination.
* FDA was not responsive to credible evidence of contamination of heparin 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 OSCS-contaminated heparin.
* FDA’s oversight approach to Chinese heparin firms did not fully take into account ongoing market conditions in the Chinese heparin industry.
* FDA’s lengthy open criminal investigation into an aspect of heparin contamination suggests difficulties and challenges in enforcement against criminal economic adulteration.
The leaders requested documents and answers to questions outlining those problems by April 12, 2016.
Read the full letter online here. Related Items
* Letter to FDA Regarding Contamination of Chinese Heparin Supply
