House Committee Asks FDA for More Info on Contaminated Heparin Investigations
Posted 15 March 2017 | By
Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.
In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths of nearly 150 Americans. Questions of contamination resurfaced last year when French regulators and later FDA warned a company for using crude heparin batches that potentially were out of specification.
The latest letter comes a little less than a year after several members of the same House committee expressed concerns on FDA delays to import alerts issued to more than 30 Chinese firms at the source of the contaminated heparin.
An E&C committee spokesperson told Focus via email on Wednesday: "FDA spent seven years investigating an aspect of the contamination of the U.S heparin supply. The committee is interested in learning any additional insights into the contamination that FDA might have learned from the investigation, and whether the length of time of the investigation and its closure indicate any issues that Congress may need to address to help FDA pursue actions against economically-motivated adulteration in the future."
The letter notes that during a committee staff briefing, FDA’s Office of Criminal Investigations said that both investigations into the contaminated heparin are now closed, as of November 2016.
But the committee is now seeking all documents related to both investigations, one of which was spun off from the initial one in 2009.
The letter was sent by committee Chairman Greg Walden (R-OR), Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), Health Subcommittee Chairman Michael Burgess, M.D. (R-TX) and full committee Vice Chairman Joe Barton (R-TX).
Committee Leaders Request Documents Related to Heparin Contamination Crisis