House Committee Rips FDA on Troubled Drug Compounders

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House Committee Rips FDA on Troubled Drug Compounders

April 17th, 2013 // 2:09 pm @

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After months of anticipation, a House committee is holding a hearing today to review a scathing report about the extent to which the FDA knew about the manufacturing issues at the New England Compounding Center, which was tied to a nationwide outbreak of fungal meningitis, and a related compounding pharmacy called Ameridose. Since the outbreak, more than 700 cases have been reported, including 53 deaths, in what has been described as the worst public health crisis in the US in decades.

For the past few months, the FDA has skirmished with the House Energy and Commerce Committee over its legal authority to sufficiently regulate compounders, given a pair of confusing US Supreme Court rulings and a patchwork of state regulations. FDA commish Margaret Hamburg, in fact, is testifying again to defend agency actions (WATCH HERE). Just the same, the committee and a growing chorus of consumer watchdogs says the FDA has had authority to regulate compounders that act more like big drugmakers by producing large quanitities of medicines without individual patient prescriptions and shipping across state lines.

However, NECC had been on the FDA radar  – on and off – over the past decade. The agency inspected the compounder in 2002 and issued a 483 inspection report detailing various problems and then issued a warning letter in 2006. The committee argues the FDA should have taken enforcement action, but FDA officials have insisted they did not have adequate legal authority to effectively police thousands of compounders that are not required to disclose all of their activities and can push back against oversight efforts.

The committee, however, is not buying this. In its report, the FDA is chastised for a number of alleged missteps. After reviewing some 27,000 documents from the FDA, the committee argues the agency considered additional inspections and potential enforcement actions, but failed to do so. In fact, the FDA earlier this year began a concerted campaign to inspect compounders and issued numerous inspection reports, a move that FDA officials acknowledged to Pharmalot could have been undertaken any time in the past few years (read here).

Citing documents, including dated January 14, 2006, Steven Silverman*, who at the time was director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluatoin & Research, was forwarded an email from an individual in Texas outlining NECC’s distribution of multiple-use vials of injectable methotrexate. “On a subsequent but related exchange, he copied Samia Nasr, then-Team Leader of CDER’s Compounding Team, and stated, ‘As we discussed, NECC is a repeat player, so it might deserve attention that other operations wouldn’t merit.  But the team is caught up with a range of high-profile issues, so this may need to wait (especially absent reported injury),’ ” according to the committee.

In October 2008, the FDA Los Angeles District Office received a complaint about a patient who reported an adverse reaction to an NECC product. The committee says that, in response to a recommendation to follow up made by an FDA district compliance officer, the agency did not conduct an inspection because the 2006 Warning Letter was still pending. And a response letter to NECC, which itself sent a letter in 2007 regarding the 2006 violations, was not sent to the compounder until 2010, warning a failure to correct various problems could result in enforcement action including seizure of products or an injuction.

Then in February 2009, the FDA had received test results about Phosphatidyl choline injectable medicines made by NECC and an FDA compliance officer emailed others in the agency that CDER sought an insection to determine if a recall was warranted. “The drug is superpotent and not approved and should be recalled,” the office wrote. But the move was never made, and the FDA confirmed no action was taken, according to the comnmittee, although the document do not explain the reason for this decision.

The committee has harsh words for Hamburg, in particular. Why? Documents cited indicate that, in May 2011, the FDA New England District compliance officer responsible for NECC spoke to an optometrist with the Veterans Administration, who asked about using NECC to repackage Avastin into single-dose units. “This communication is significant, because it once again confirms that FDA understood that NECC was acting more like a manufacturer than a traditional compounding pharmacy,” the committee says, noting that an FDA e-mail acknowledged NECC was acting more like a manufacturer than compounder. “During the November 2012 hearing, Hamburg failed to mention that FDA knew that NECC was operating like a manufacturer and the agency had failed to pass along any information to the Massachusetts Board,” the committee notes.

And the committee points out that, unlike NECC, Ameridose had registered with FDA as a manufacturer and repackager. But from 2009 through 2012, the FDA failed to take any action even though complaints rose. “Despite an increasing number of complaints, FDA decided to further delay action against Ameridose. It was FDA’s job to intervene to protect the public health The meningitis outbreak would not have occurred if not for NECC’s willingness to consistently cut corners and prioritize the expansion of their business over the safety of their products. However, contrary to previous FDA statements, NECC was not operating in the shadows. NECC was on FDA’s radar since 2002. FDA had a deep understanding of the nature and scope of both NECC and Ameridose’s operations,” the committee concludes (HERE IS THE COMMITTEE REPORT).

Separately, a coalition representing pharmacists, hospitals and the public interest recently reached a consensus on several recommendations to improve oversight of pharmacy compounders at both the federal and state levels. The Pharmacy Sterile Compounding Summit, which was held in February, included representatives of pharmacy organizations, doctors, hospitals and healthcare systems, compounding pharmacies, the FDA, state pharmacy boards, and the U.S. Centers for Disease Control and Prevention.

The recommendations include strengthening federal oversight for activities that go beyond traditional state-regulated compounding and represent a high public health risk; risk factors to be considered include volume of production, breadth of distribution and risk of the products being made; federal and state authorities should have clear roles and responsibilities to ensure the safety of compounded sterile drugs without leaving oversight gaps or duplicating efforts; regulators should consider establishing new quality standards for large-scale sterile compounding, and state pharmacy inspectors should have standardized training and assessment tools for consistent and robust oversight (read more here).

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