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FDA may get more teeth after outbreak

29th October 2012

The US drug regulatory body has little legal power to regulate the compounding of pharmaceutical supplies, a new report has found in the wake of a deadly outbreak of rare fungal meningitis.

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The Food and Drug Administration (FDA) cannot impose legally binding requirements on compounding pharmacies like the New England Compounding Center (NECC) in Massachusetts, which is at the heart of a fungal meningitis outbreak that has killed 25 people and infected 337 in 18 American states, according to a report by Massachusetts congressman Edward Markey.

NECC suspended operations and laid off most of its employees after state and federal inspections found unsanitary conditions at its facility, including surfaces coated with mould and bacteria and dirty sterilisation equipment.

FDA commissioner Margaret Hamburg said the agency was committed to working with Congress and others to boost the agency's regulatory powers.

The FDA would work with legislators to get "the authority we need to help prevent tragedies like this from happening again," Hamburg said.

She said that Congress had already seen substantial debate about the appropriate amount of FDA oversight of compounding pharmacies, but that challenges from the industry had resulted in a lack of consensus on the issue.

Hamburg confirmed that the FDA does indeed have less authority over compounding pharmacies than it does over pharmaceutical manufacturers.

Congress now looks likely to debate giving the FDA new powers in the wake of the public health crisis surrounding contaminated steroid injections.

Public advocacy groups have hit out at the agency for failing even to use the powers it does have to prevent the meningitis outbreak.

The FDA appears to have been aware of potential health risks at the NECC as early as 2002, but did little to follow up on a warning letter issued to the pharmacy in 2006.

Hamburg said the FDA was currently focusing on containing the immediate crisis, which it is in the process of investigating.

Compounding pharmacies alter, mix or recombine ingredients to make a drug that meets the special needs of a patient, according to their doctor's prescription.

However, some have expanded to look more like manufacturing facilities than pharmacies, while still being subjected to less stringent forms of regulation.

According to investigators working for Markey, state governments cannot perform the kind of safety oversight necessary to ensure that compounding pharmacies are operating safely.

Without tighter controls, more drug-related outbreaks could occur.

Compounding pharmacies have struck down previous attempts to allow the FDA legally binding powers to regulate them, most notably with their challenge of a 1997 law granting it oversight of effective "new drugs".

But Markey's research staff said that current FDA guidance documents do not establish legally enforceable rights or responsibilities and do not legally bind the public or the FDA.

Meanwhile, Massachusetts health officials shut down another compounding pharmacy after a surprise inspection last week found conditions that called into question the sterility of its products.

The pharmacy, Infusion Resource in Waltham, gave up its business licence after officials at the state public health department found "significant issues" with the environment in which medications were being mixed.


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