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Senators Press State Regulators on Compounding Oversight

Posted 20 November 2012 | By

Federal officials may have received the bulk of legislators' ire during two separate hearings on the safety of pharmaceutical compounding products in recent hearings, but now Senate legislators are taking aim at state regulators, asking whether those authorities have adequate resources in place to protect public health.

In a letter sent to all 50 state boards of pharmacy on 19 November 2012, bipartisan members of the Senate's Health, Education, Labor and Pensions (HELP) Committee said recent regulatory failings had raised "serious questions about the level of oversight that a large-scale compounding pharmacy was subject to."

The legislators were referring to a recent outbreak of fungal meningitis, now understood by regulators to have emanated from a compounding facility owned and operated by the New England Compounding Center (NECC). Regulators recently released the results of an inspection of NECC's Framingham, MA facility which noted the presence of numerous microbial contaminants.

Just as troubling as the facility's lapses to legislators was the oversight of state and federal legislators. Documents from the US Food and Drug Administration (FDA) show the agency had inspected the facility several times during the last decade, but had failed to shut it down despite finding similar types of contamination during prior inspections. The agency meanwhile maintains that its authority to inspect the facilities has been complicated by federal court decisions, leaving much of the oversight to state boards of pharmacy.

At present, noted the senators, pharmaceutical compounders are not required to register with FDA, but instead must do so with state regulators, making it difficult to assess how many pharmaceutical compounders actually exist nationwide.

The legislators last week expressed frustration at FDA Commissioner Margaret Hamburg's inability to answer for them how many facilities exist, and their letter seems intent on finding that out for themselves.

"This inquiry will help lawmakers to assess the scope of these companies nationwide," the committee wrote. "Today's letters will assist the committee as it determines what changes need to be made to ensure that compounded drugs are safe and available for patients and hospitals who need them."

But if legislators thought FDA was deficient in its regulation of NECC, their letter implies that they are just as perplexed by state regulators' lack of response to similar, if not the same, information.

"Our ongoing investigation into this matter has revealed that NECC was previously the subject of investigations and enforcement actions as a result of complaints to state and federal regulators by various parties, including from other state pharmacy oversight agencies.  These complaints and other enforcement actions should have drawn attention to concerns regarding the quality and sterility of products produced by NECC, which were documented as far back as 13 years ago, as well as to the fact that NECC was operating what appears to be a large-scale drug manufacturing operation."

Legislators said it was "unclear" why NECC was allowed to continue to operate across state lines or was licensed in so many states despite compounding at large volumes across state lines.

The committee said it is seeking nine pieces of information from state regulators, including whether they assess the volume of products manufactured by facilities, whether they assess facilities for compliance with US Pharmacopoeia (USP) guidelines, if regulators had reported adverse events to FDA for products manufactured by NECC, a listing of all compounders operating within the state, and actions taken since the meningitis outbreak.

The HELP Committee's letter may be found on the committee's website.

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