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FDA proposes charging compounding pharmacies fees to fund extra oversight in wake of meningitis outbreak

The agency feels it doesn’t have enough authority over specialty pharmacies

Compounding pharmacies across the country are likely having flashbacks to mean high school teachers who would give the whole class extra homework to punish one student’s misconduct. Except now the teacher is the Food and Drug Administration (FDA), and the homework is extra fees.

The pharmacies have last year’s deadly meningitis outbreak to thank for this predicament. The outbreak was linked to a compounding pharmacy in Massachusetts with a history of poor contamination control. In an official blog post on Friday, FDA Commissioner Margaret Hamburg proposed charging compounding pharmacies fees to help pay for the additional oversight needed to prevent such an outbreak from happening again.

Congress has approved such fees before. For example, fees from pharmaceutical companies help fund the FDA’s drug review process. But Hamburg says the FDA will explore other options with Congress as well, such as mandating labels on compounded drugs that state the product’s source.

One way or another, the FDA will likely seek more authority over specialty pharmacies—since the meningitis incident, the agency has claimed it doesn’t have enough.

"Even during this time of heightened awareness, our inspectors are being delayed in their work or denied full access to records at some of the facilities we are inspecting," Hamburg wrote in the blog.

Read more at Thomson Reuters.


For more coverage of the meningitis outbreak on InsideCounsel, see below:

Pharmacy linked to meningitis outbreak paid owners $16 million in 2012

Manufacturer of allegedly contaminated steroid tries to distance itself from meningitis outbreak

Chief pharmacist of contaminated steroid manufacturer subpoenaed for meningitis hearing

Lawsuits against pharmacy that allegedly caused meningitis outbreak on the rise in Michigan

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