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Hamburg, FDA inspection practices go under microscope in meningitis outbreak

Latest hearings follow House report saying FDA is too strict
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Congress is again taking a hard look at the FDA and its plant oversight methods as House and Senate committees will hold hearings on the agency's actions related to the compounding pharmacy tied to a national, and deadly, outbreak of fungal meningitis.

The House Energy and Commerce Committee has called FDA Commissioner Margaret Hamburg to testify Nov. 14 as it looks at why New England Compounding Center (NECC) was allowed to operate in what appears to be unsterile conditions after FDA inspectors found issues with the company during a 2006 inspection. The committee is also asking for testimony from Massachusetts state regulators and Barry Cadden, co-owner of NECC. The next day, Hamburg is to appear before the Senate Health, Education, Labor and Pensions Committee, which also is investigating the company. Drugs from NECC, which it was selling throughout the country, are tied to the outbreak that has now infected about 420 and killed about 30. The figures change almost daily.

State authorities customarily oversee compounding pharmacies, which traditionally serve local markets. The FDA inspected the NECC plant in Framingham, MA, in 2006 after it received a complaint that the compounder was improperly repackaging Roche's ($RHHBY) cancer drug Avastin. The inspection found a variety of problems that raised questions about NECC's sterility practices but the agency did not do a follow-up inspection. That is, until recently, when patients getting steroid injections with an NECC drug began showing up in hospitals.

It will be the second time in about 6 months that the House has looked hard at the FDA. A report this summer by a House subcommittee raked Hamburg and the FDA over the coals, saying that its overly aggressive plant inspections led to plant closures that were responsible for serious drug shortages in the U.S. The report tied an increase in inspections, plant closings and drug shortages to Hamburg's tenure. The agency refuted the House contention saying that problems at the plants required action because they potentially put patients in danger. The report was considered political since the House is controlled by Republicans and the report criticizing an appointee of President Obama came during the presidential campaign.

The latest inquiries come as support grows for giving the FDA clear oversight over at least those compounders whose scale puts them more in line with the drug manufacturers that the FDA inspects regularly. Earlier rules designed to give the agency more authority were challenged in court by the compounding industry and fell before a Supreme Court ruling. Hamburg has recently said she will gladly work with Congress to produce legislation that would give the agency the power to prevent a future outbreak of this nature.

- here's the Reuters story

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