The U.S. House Energy and Commerce Committee can't seem to get enough face time with FDA Commissioner Margaret Hamburg. She is again being called before the committee, which last year lashed out at her over FDA oversight of compounding pharmacies, one of which is tied to a fungal meningitis outbreak that infected hundreds, dozens fatally. The committee is looking for some more answers.
|FDA Commissioner Margaret Hamburg|
Since that hearing the FDA has launched inspections of the largest U.S. operations. In fact, the FDA today posted a recall from Green Valley Drugs in Henderson, NV, which is voluntarily recalling all of the sterile products after the FDA raised questions about their sterility and the compounders' quality processes. It is the fourth compounder to be asked to recall products since the inspections began.
Hamburg has asked Congress to pass a law that gives the FDA clear authority to oversee the largest compounders. During her last march up the Hill to the committee meeting, she explained that a lack of clear authority had kept the FDA from giving more attention to compounding pharmacies, which make up a small but growing niche of drug manufacturing. But as Regulatory Focus points out, that hearing got very heated, with some members accusing the commissioner of lacking the leadership it would have taken to do the job.
Most compounders are small operations that mix special drugs requested by doctors for difficult cases. They have traditionally been overseen by state authorities. But some compounders have expanded in recent years, picking up business in the face of drug shortages. Some are now more like small manufacturers, selling products all over the U.S., raising questions of whether the FDA should have been overseeing them. The U.S. is not the only country to face difficulties with this part of the business. Canadian officials last week reported that chemotherapy drugs from an Ontario compounding pharmacy given to nearly 1,200 patients failed strength specifications because they contained too much saline solution.