Watchdog group pressures FDA about contaminated syringes
June 10th, 2009 by Jennifer Walker-Journey
Watchdog group Project on Government Oversight (POGO) is asking the Food and Drug Administration (FDA) inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products.
POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. Now it is asking questions about the contaminated pre-filled heparin and saline syringes manufactured and sold by AM2PAT.
In a letter to FDA commissioner Margaret A. Hamburg, the organization said the FDA missed chances to act before a contaminated lot of 74,000 syringes were shipped by AM2PAT to hospitals and health care centers. Earlier this year, two officials with AM2PAT were sentenced to prison after pleading guilty to crimes related to the contamination.
“Why did the FDA fail in its duty to keep a dangerous medical product, AM2PAT’s syringes, off the market?” asks POGO in its letter. “We believe that part of the reason is a culture within the FDA that habitually maintains a relationship with manufacturers that is too collegial and too tolerant. There is a reluctance by the FDA to take corrective action stronger than a Warning Letter, even when stronger action is clearly indicated, as it was at several points in the history of the AM2PAT case. There is an additional reason for the FDA’s failure: the grossly inadequate resources available to the FDA for inspection and enforcement. This is mainly a budgetary problem that can, of course, be solved only by the White House and Congress.”
POGO says that the FDA knew of AM2PAT’s failures for more than a year but has issued no public statement about the failures. “The silence on the part of the FDA officials would by itself indicate the need for an investigation and report by the Inspector General.”