System did not protect from meningitis

The system failed to protect patients from preventable death from meningitis, a congresswoman from Colorado said at a hearing at the Capitol in Washington. Rep. Diana DeGette, D-Colo., a member of the House of Representative's Energy and Commerce Committee and its Subcommittee on Oversight and Investigations, said at the hearing Congress needs to clarify the Food, Drug and Cosmetic Act, which "apparently limits the U.S. Food and Drug Administration's jurisdiction over compounding pharmacies." "We need to make sure that for these large pharmacies have the ability to act and to act quickly on behalf of patients. In 2011, the Colorado State Board of Pharmacy determined that the New England Compounding Center was distributing unlicensed and unregistered drugs in the state and issued a cease and desist order," DeGette said at the hearing. NECC, the compounding pharmacy in Framingham, Mass., produced about 17,000 doses of the injectable steroid methylprednisolone acetate of which some 14,000 doses were used to treat back and joint pain linked to 448 cases of meningitis and infection, killing 32. "But this was not all the Colorado officials could do, and it was not enough to stop NECC's action. Colorado officials notified the Massachusetts Board of Pharmacy and Massachusetts did nothing," DeGette said. "The Colorado Board of Pharmacy did the right thing, but the system failed. NECC did not improve its operation. The FDA did not act, and Massachusetts did not act." FDA inspectors and officials were repeatedly informed of problems at NECC, but the strongest action taken by the FDA was a warning letter sent to the company in 2006, a letter that appeared to have very little effect, DeGette said. "The FDA tells us that they were hobbled by questions about whether they had the legal authority to address the problems at the NECC," DeGette said. "If this is true this is a problem that demands this full committee's immediate attention." Rep. Ed Markey, D-Mass., and a member of the Energy & Commerce Committee, said he prepared a report for today's hearing that said NECC was no stranger to federal and state regulators. "It had been the subject of eerily similar safety complaints in 1999, 2001 and 2002, yet in 2002, NECC owner Barry Cadden was appointed to the state's task force charged with developing new regulations for compounding pharmacies. And in June of 2006, the state board waived sanctions," Markey said at the hearing. Markey's report, "Compounding Pharmacies, Compounding Risk" describes the nature of regulatory oversight and gaps in legal authority that, even before the current meningitis outbreak, led to at least 23 deaths and 86 serious illnesses or injuries in at least 34 states. The violations included compounding pharmacies selling copies of commercially-available drugs, selling drugs made using ingredients that were not FDA-approved or were recalled for safety or effectiveness reasons, cases where sterile facilities were visibly dirty and contamination of the drug product was known to have occurred and either selling drug products without a valid prescription or manufacturing large quantities of drug products, the report said. The report also said the state Boards of Pharmacy do not typically and consistently oversee the safety of the drugs made by compounding pharmacies. "The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years. But a patchwork of state regulation, incomplete and often inaccessible information by compounding pharmacies as well as the industry efforts to thwart better government oversight have complicated efforts to understand the true scope of this problem," Markey said. "The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight. This tragedy demands the strongest response from Congress, federal and state authorities to ensure safeguards are in place to protect patients."