The country's top medical regulator is preparing to tell Congress that new laws are needed to police large specialty pharmacies like the one at the center of a deadly meningitis outbreak.
Testimony released ahead of the first congressional hearing on the incident shows that Food and Drug Administration Commissioner Margaret Hamburg will ask lawmakers to give her agency more authority and funding to oversee compounding pharmacies.
Hamburg is one of four witnesses called to testify before the House Energy and Commerce Committee. The committee will also hear from a Massachusetts health official, the owner of the Framingham, Mass.-based pharmacy tied to the outbreak and the widow of a patient killed by the company's product.
About 440 people have been sickened by contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September. Compounding pharmacies have been linked to occasional safety problems for decades, but the current outbreak of fungal meningitis is the deadliest case in modern U.S. history, according to industry experts.
That has put the NECC at the center of congressional scrutiny as lawmakers consider tighter regulation of compounding pharmacies, which have long operated in a legal gray area between state and federal laws.
"FDA's authority over compounding pharmacies is limited by law and is not suited to effectively regulate the evolving compounding industry," Hamburg said, in a statement released ahead of the hearing. "We need a clear path forward that is proactive and preventive."
Compounding pharmacies traditionally fill special orders placed by doctors for individual patients, turning out a small number of customized formulas each week. They are typically overseen by state pharmacy boards, though the FDA occasionally steps in when major problems arise. Some pharmacies have grown into much larger businesses in the last 20 years, supplying bulk orders of medicines to hospitals that need a steady supply of drugs on hand.
NECC shipped more than 17,000 single-dose vials of the steroid linked to the outbreak, which were given to an estimated 14,000 patients in 23 states.
Hamburg says Congress should put in place a two-tier system in which traditional compounding pharmacies continue to be regulated at the state level, but larger pharmacies would be subject to FDA oversight.
Pharmacies that ship bulk product or produce complex drugs would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. These non-traditional compounding pharmacies would also have to meet the more stringent manufacturing standards required of pharmaceutical companies.
"In light of growing evidence of threats to the public health, the administration urges Congress to strengthen standards for non-traditional compounding," Hamburg states in her testimony.
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