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Sen. Tom Harkin (D-Iowa)
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Harkin aims to fast-track legislation on compounding pharmacies, drug tracking


By Rich Daly
Posted: May 22, 2013 - 3:15 pm ET
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A senior Senate Democrat aims to expedite legislation that would establish both a track-and-trace system for drugs and a new regulatory framework for compounding pharmacies.

Sen. Tom Harkin (D-Iowa), chairman of the Health, Education, Labor and Pensions Committee, told Modern Healthcare that he is pushing for the full Senate to vote in June on the combined legislation after his panel gave it unanimous approval Wednesday. A Harkin spokeswoman contacted Modern Healthcare later and said a July vote is more likely.

Before passage, the committee voted to combine the Pharmaceutical Compounding Quality and Accountability Act and the Drug Supply Chain Security Act.

The compounding bill, which was endorsed by some hospitals groups, followed the nationwide outbreak of fungal infections stemming from contaminated drug treatments compounded by the New England Compounding Center. Senators blamed the incident, which was linked to 741 cases of fungal infections and 55 deaths—as of May 6—on a lack of regulatory oversight at the state level.

The compounding bill's passage came on the same day the committee released a bipartisan report that found a “shocking failure to act” by regulators or legislators, said Sen. Pat Roberts (R-Kan.) (PDF). He and others were critical of Congress for failing to advance a compounding oversight measure for the past 10 years, despite evidence of deaths and serious injuries linked to compounding pharmacies since at least 2001, as chronicled in the report.

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The compounding legislation would give the Food and Drug Administration regulatory authority over pharmacies that mix sterile drugs without a prescription and sell those drugs across state lines. Such “compounding manufacturers” would have to register with the FDA, inform the agency about drugs they develop, investigate and report adverse events, and include a label that indicates the drugs were compounded.

Hospital advocates pushed for an exemption that was included in the bill and would allow state regulation to continue for health systems that share sterile products among their hospitals, such as systems with hospitals in more than one state.

“In addition, the purpose of compounding carried out by hospital and health system pharmacies is to address the need of identifiable patients pursuant to a prescription order, which is the fundamental distinction between traditional compounders and compounding manufacturers,” Blair Childs, a senior vice president at Premier healthcare alliance, wrote the committee on May 20.

The exemption drew the ire of compounding advocates. The International Academy of Compounding Pharmacies was concerned that the bill would eliminate safety assurances for hospital patients and create some confusion between federal and state-level regulators, according to a spokesman for the group.

Committee members said the legislation may need further tweaks before the full Senate votes on it. For instance, Sen. Johnny Isakson (R-Ga.) said he was working on regulatory waivers for home infusion therapy and “partial compounding” used in ophthalmology.

“I don't want to see the unintended consequence of this lead people into hospitalization when home healthcare therapy and home infusion therapy could be possible, as well,” Isakson said.

The compounding bill was amended to add a previously separate measure creating a track-and-trace system for pharmaceuticals down to the unit level. The drug tracking legislation broke a years-long log jam among healthcare industry groups over efforts to more closely monitor the nation's drug supply amid growing concerns over threats posed by theft and counterfeit or substandard drugs. Those concerns of drug-supply problems included last year's FDA notification of up to 500 U.S. medical practices that they may have purchased counterfeit versions of a cancer drug.

The industry-brokered agreement, on which the bill was based, included a 10-year phase-in period for a national system to replace state regulation of drug supply chains in their regions. Previous proposals for shorter start times for a national system had drawn hospital opposition over concerns that providers would face penalties for timeframes they could not meet.

Sen. Richard Burr (R-N.C.) said the bill established a “workable pathway” to unit-level tracing, while giving providers “critical regulatory certainty.” Burr and others criticized the “patchwork” of state tracking requirements were driving up healthcare costs among healthcare companies operating in multiple states.

Separate draft legislation on track-and-trace and drug compounding by House Republicans also have begun to circulate, and leaders there also have described their passage as a priority.

Follow Rich Daly on Twitter: @MHrdaly


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