At the April 29, 2008 hearing entitled, “The Heparin Disaster: Chinese Counterfeits and American Failures,” Rep. Bart Stupak, Chairman of the investigations panel of the House Commerce Committee, asked FDA representatives if the FDA needs subpoena authority. This subpoena power would give the FDA the power to demand certain documents from companies who have sold contaminated drugs, such as Baxter and SPL. Without this ability, the agency is powerless to obtain internal company documents that a company itself chooses to withhold. Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, and Deborah Autor, Director of the FDA’s Office of Compliance, replied that this power “would be very helpful.”


Last week, Stupak followed up on his inquiry, sending a letter to the FDA Chief, Andrew C. von Eschenbach, M.D. This letter emphasized the importance of giving the FDA subpoena power and asked the FDA Chief to stand by the statement of Dr. Woodcock and Ms. Autor. (Wall Street Journal, 5/20/08, “Rep. Stupak Nudges FDA Toward Subpoena Power.”)


As noted by Stupak, the FDA is one of the few Federal agencies that lack subpoena power. In his letter, Stupak writes, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.”


After six years of debate whether Congress should give the FDA subpoena power, the most recent heparin disaster and the FDA’s inability to fully investigate what went wrong, should signal the importance and need to immediately provide this power. Stupak is correct. Without the ability to obtain all documents necessary for a full and fair investigation, we will likely never know the full truth as to how fake heparin was allowed to be sold and injected into hundreds of Americans. More importantly, we cannot ensure that it will not happen again.


-Submitted by Pamela A. Borgess