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Congress hears testimony on new regulations for pharmacies

A congressional oversight committee heard testimony this week on how regulations should be changed to better protect consumers from dangerous drugs manufactured at compounding pharmacies. The issue became a matter of public concern after the cause of a deadly fungal meningitis outbreak proved to be unsanitary conditions at a compounding pharmacy.

The outbreak has infected 461 patients so far and has been linked to 32 deaths. Up to 14,000 patients in 23 states were exposed to the tainted medication, and health officials expect that more cases could still emerge.

Texas-based International Academy of Compounding Pharmacists (IACP) told the Senate oversight committee that current laws were sufficient for the regulators to have taken action to prevent the deadly meningitis outbreak. A representative from the group testified that new regulations are not needed to protect patients from dangerous drugs from compounding pharmacies, but rather that the FDA should more effectively enforce current laws.

The back-and-forth between industry representatives and the Food and Drug Administration highlights the regulatory loopholes and gaps in enforcement that combined to lead to this tragic outbreak. It is likely that a variety of factors, including an intentional avoidance of current regulations by the pharmacy and a lack of stricter laws and enforcement led to the conditions inside the pharmacy that resulted in the outbreak.

"The state and the FDA should have worked together to force the pharmacy to register as a manufacturer," said the spokesperson for the IACP. "NECC showed blatant disregard for existing rules and regulations."

Patients who were injured by the contaminated steroids deserve justice and to see the responsible parties identified and held accountable for their wrongdoing. Many patients have already chosen to file products liability or medical malpractice lawsuits against the pharmacy or the doctor who administered the shot.

Source: Reuters, "Drug industry resist more oversight despite meningitis outbreak," Nov. 15, 2012.

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