The Project On Government Oversight (POGO) sent a letter to Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration on June 6, 2009, requesting she call for an investigation by the Department of Health and Human Services Inspector General.
The issue is a specific instance of regulatory failure in the Center for Devices and Radiological Health (CDRH) at the FDA: the case of AM2PAT, Inc., a small company that manufactured and sold syringes. In December 2007, some of the syringes were found to have been contaminated by bacteria that caused deaths and serious illnesses. Two years later, two officials of AM2PAT were sentenced to prison after pleading guilty to crimes related to these events. At least four patients died and hundreds were harmed. Some suffered permanent, severe brain damage.
The AM2PAT case is the subject of a major story, on June 6, in ProPublica and the Chicago Tribune, with Christina Jewett as the main author. But a ProPublica investigation by Christina Jewett reveals the Food and Drug Administration missed several chances to stop the syringes from getting out.
While senior officials of AM2PAT were clearly responsible for this tragedy, the FDA bears much of the blame for allowing it to happen.
“The role of the FDA in this case as a possible enabler of wrongdoing has not been publicly acknowledged either by the FDA or the Inspector General. Accordingly, we ask that you request an investigation by the Inspector General of the Department of Health and Human Services. Such an investigation is long overdue,” said Danielle Brian, Executive Director in POGO’s letter.
As shown by its own records, the FDA had known for a long time about safety problems at AM2PAT. Repeatedly, for at least two years before it finally took decisive action, the FDA was given ample warning that AM2PAT was failing to ensure the safety of the company’s syringes. Months before the outbreak, a whistleblower working at the AM2PAT plant sent the FDA an email identifying herself and warning explicitly about unsuitable conditions in the plant.
In the letter to the Commissioner, POGO maintains that part of the reason for this failure is a culture within the FDA that habitually maintains a relationship with manufacturers that is too collegial and too tolerant. Too often, there is reluctance by the FDA to take corrective action stronger than a Warning Letter, even when stronger action is clearly indicated. POGO acknowledges these failures also stem from the grossly inadequate resources available to the FDA for inspection and enforcement.
A thorough IG investigation of the AM2PAT failures will enable the IG to make recommend policy changes and reforms to the Secretary of HHS and the Congress necessary to ensure the public’s safety is protected against criminal misconduct and lax oversight by the FDA.