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.”

SOURCE: Heparin Recall › Watchdog group pressures FDA about contaminated syringes

Earlier this week two former workers at the plant, plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma, were sentenced in federal court to more than four years in prison for allowing the tainted drugs into hospitals and clinics in Colorado, Florida, Illinois and Texas. Last week, the company’s chief executive, Dushyant Patel, was indicted on 10 charges for fraud and selling adulterated medical devices. A warrant is out for his arrest.

The drugs were not produced at the plant, but were put into the syringes and shipped to the hospitals and clinics from there. According to Patel, the company recalled the syringes a year ago after federal officials began investigating the outbreak.

“Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product,” said U.S. Attorney George Holding to the Associated Press. “As we’ve seen in this case, such lies can literally mean the difference between life and death.”

SOURCE: Heparin Recall › Two sentenced for role in tainted heparin, saline syringes