FDA reacted slowly to reports of tainted drugs from NC plant

The (Raleigh) News & ObserverFebruary 25, 2009 

Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.

The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency pull any of the drugs off the market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted syringes of heparin and saline that have been linked to five deaths. Hundreds more people were sickened, often after receiving the medicines during chemotherapy, kidney dialysis and other intravenous procedures.

Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company's president, Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities believe he fled to his native India.

Conditions at the plant, detailed in court documents and photographs, depict a facility in flagrant violation of proper manufacturing processes. Prosecutor Jason Cowley said the company's "chief microbiologist" was a teenager who dropped out of high school. A key piece of laboratory equipment designed to catch evidence of contamination was broken, and another gauge was out of commission for a year. The so-called clean room, where air is carefully controlled to reduce the spread of germs, was ventilated with an ordinary room fan.

The U.S. Food and Drug Administration – charged with overseeing more than 10,000 drug-device makers in addition to thousands more pharmaceutical manufacturers, food processing companies and animal-feed plants – received numerous complaints about the company's heparin products months before the bacterial infections erupted in December 2007 and January 2008.

To read the complete article, visit www.newsobserver.com.

McClatchy Washington Bureau is pleased to provide this opportunity to share information, experiences and observations about what's in the news. Some of the comments may be reprinted elsewhere in the site or in the newspaper. We encourage lively, open debate on the issues of the day, and ask that you refrain from profanity, hate speech, personal comments and remarks that are off point. Thank you for taking the time to offer your thoughts.

Commenting FAQs | Terms of Service