Report Blames Both FDA and Pharmacy for Meningitis Outbreak

A congressional report released this week blasts the FDA for dropping the ball on oversight of a New England compounding pharmacy linked to a deadly fungal meningitis outbreak that has killed 43 people and sickened hundreds more.  

In a report (PDF) released this week by the U.S. House of Representatives’ Committee on Energy and Commerce, House Republicans indicate that FDA documents prove that the agency’s earlier allegations that it was unaware that the New England Compounding Center (NECC) was unsafe and acting as an underground drug manufacturer were false. The report also disputes FDA officials’ claims that the agency’s hands were tied due to enforcement restrictions.

The report comes as many are still recovering from fungal meningitis and other infections caused by contaminated epidural steroid injections and other compounded products distributed nationwide by NECC, which were recalled in early October 2012. More than 700 confirmed cases have been linked to the fungal meningitis outbreak, and an estimated 14,000 patients may have received contaminated shots.

FDA Did Not Use Existing Enforcement Powers: Report

In November, FDA Commissioner Margaret Hamburg went before lawmakers and told them that the agency lacked enough enforcement muscle to regulate the nation’s compounding pharmacies. However, some lawmakers of both parties questioned whether that was true, after indications suggested that the FDA and Massachusetts health officials knew NECC had problems and failed to act.

The report found that the FDA knew of the problem since at least 2002 and repeatedly failed to use its existing inspection powers to intervene. Investigators found 27,000 pages of documents related to problems at the compounding pharmacy, and a number of reports within the FDA calling for action that appear to have been ignored. The report blamed the outbreak on both NECC and the FDA.

“It can and should be stipulated that the fungal meningitis outbreak would not have occurred if not for a company whose management was willing to consistently cut corners and prioritize the expansion of their business over the safety of their products,” the report concludes. “That being said, NECC was not operating in the shadows. NECC had been on FDA’s radar since 2002 and never left.”

The Republican report says that their committee members will support increased FDA regulatory power if that is what it takes to protect public health from rogue compounding agencies. However, the committee report determined that it may not help if there are fundamental issues inside the FDA that led to its refusal to use its existing powers against NECC to protect the public health.

The report came in advance of a hearing on April 16, during which FDA Commissioner Margaret Hamburg admitted that the agency did not bring its full weight to bear against NECC, which now faces a number of fungal meningitis lawsuits and has been shut down. Its owners have declared bankruptcy in the face of the likely staggering liability costs.

Commissioner Hamburg said the FDA had erred by being more afraid of lawsuits from compounding pharmacies than potentially dangerous drugs getting on the market.

It also comes as the FDA and state agencies have turned their attention to compounding pharmacies nationwide, resulting in surprise inspections and a number of drug recalls due to sterility concerns.

On April 15, the FDA announced recalls for sterile drug products made by two Texas compounding pharmacies; ApotheCure, Inc. and NuVision. In both cases the drugs were recalled due to sterility concerns.

Some lawmakers noted that the recent inspections and recalls suggest the FDA has had the power to regulate compounding pharmacies all along, but did not use it.