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FDA Finds More Problems at Compounding Pharmacies

The New England Compounding Center is allegedly responsible for one of the greatest drug disasters in modern history, causing 53 deaths and making at least 680 other people sick after sending out drugs tainted with fungus, which caused hundreds of cases of meningitis.

The conditions found at the New England Compounding Center were in clear violation of safety standards and the tragic outcome that resulted was enough to send fear through the hearts of every patient depending upon a drug produced at a compounding pharmacy. 635810_softgel_capsule.jpg

Unfortunately, the news for patients is not good. According to a recent Washington Post article, the bad conditions and breached safety standards don’t just exist at the New England Compounding Center. In fact, the article indicated that there were “widespread” safety issues including “dozens of potentially dangerous safety problems.” Our Boston drug injury attorneys know that even one bad compounding pharmacy can cause hundreds of illnesses and deaths. With a widespread problem throughout the industry, the potential implications could be terrible for public health, not to mention patients who are victimized.

FDA Finds Widespread Safety Problems

Although New England Compounding Center was reportedly the compounding pharmacy responsible for making everyone sick, this pharmacy is far from the only one to put patients in danger as a result of failure to fulfill safety obligations. In fact, the FDA’s recent inspections conducted between February and April revealed that there were serious problems at an estimated 30 specialized compounding pharmacies.

The FDA’s investigation of Compounding Pharmacies was prompted by the disaster at the New England Compounding Center and it was the first time that the Food and Drug Administration specifically targeted these special compounding pharmacies. The inspections were considered to be “priority inspections” and the FDA specifically focused on compounding pharmacies that create high-risk sterile products (like those produced at the New England Compounding Center).

These specialty pharmacies are a key part of the multi-billion dollar compounding industry, which has not been very well regulated by the FDA prior to this terrible outbreak. The compounding facilities are not subject to the same standards as drug manufacturers although many of these compounders are masss-producing drugs.

Unfortunately, the lack of regulations and overweight led to deplorable conditions. The FDA investigation, for example, found:

  • Mold in “clean” rooms (rooms that were supposedly sterile).
  • Rust in clean rooms.
  • Tears in gloves that technicians were wearing as they worked in the compounding process.
  • Black particles of mysterious or unknown origin inside of seven different vials of an injectable medicine.

These were just some of the many safety problems found at the 30 specialized pharmacies investigated. There may be more problems but unfortunately the FDA is going to have an uphill battle to find these issues before they lead to another terrible outbreak.

The FDA has only limited authority to handle investigations of compounding agencies, with five of the pharmacies initially denying the FDA investigators access to records and facilities during the priority investigations. The FDA did prevail after getting a court ordered inspection warrant. But the agency wants Congress to give it more authority to investigate compounders of high-risk sterile products. Hopefully Congress will act and the FDA will be able to step up enforcement to prevent another disaster like the one caused by the New England Compounding Center.

If you or a loved one has suffered a drug injury in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:
CPSC Pushes National Poison Prevention Effort, April 3, 2013, Boston Personal Injury Lawyer Blog
Boston Malpractice Cases Could Stem from Painkiller Overdoses, March 16, 2013, Boston Personal Injury Lawyer Blog