Hamburg faces Senate as new compounding regulations progress

There seems to be a rhythm to the investigation into federal oversight of the compounding pharmacy industry that is playing out in the U.S. capitol. FDA Commissioner Margaret Hamburg gets called up for a House or Senate hearing to explain what lapses led to more than 740 Americans being infected with viral meningitis tied to compounded drugs, and the day before she goes, the FDA announces a recall of drugs from another compounder.

Hamburg is slated to testify Thursday before the Senate Health, Education, Labor, and Pensions Committee, along with a panel made up mostly of compounding industry officials. On Wednesday the FDA sent out a notice that The Compounding Shop of St. Petersburg, FL, recalled all of its sterile drugs after an inspection by the agency found sterility issues that could lead to microbial contamination.

Hearings began last year after the meningitis outbreak that has now killed 55 and sickened 741 was traced back to contaminated drugs made by the now-defunct New England Compounding Center in Massachusetts. Hamburg has defended the agency's response to the outbreak, saying that the FDA's authority over compounders is undefined, but she also had it launch inspections into the 30 largest compounders.

Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders, which traditionally have been regulated by state authorities. A bipartisan bill is now making its way through Congress that would do just that. According to Reuters, it would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs.

This new proposed legislation would not require the compounders to meet all of the strict regulations that drug manufacturers do, like getting preapproval of their products and labels. It would, however, prevent them from any longer making the most complex biologic drugs that are more easily contaminated. They also would not be allowed to make their own versions of FDA-approved drugs unless there is a shortage. And like manufacturers, they would have to kick in fees for the privilege of having FDA supervision.

- here's the FDA alert
- here's the Senate hearing notice
- more from Reuters

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