Pass ‘compounding’ reforms before another outbreak kills.
The headlines generated last fall by a meningitis outbreak linked to injectable drugs manufactured in filthy conditions may have faded. But Congress is sorely mistaken if members believe that the outrage over this massive pharmaceutical public health disaster and regulatory failure — 749 people were infected, 61 died — has ebbed.
Firms like the New England Compounding Center, which shipped more than 17,000 potentially contaminated vials to more than 20 states, including Minnesota, should not be operating in the regulatory shadows by exploiting the legal leeway traditionally given to Main Street pharmacists to mix (or “compound”) custom medications for clients. Instead, big compounding firms like NECC, whose dirt- and debris-filled facilities shocked investigators and the public, should clearly be subject to federal oversight like other drug manufacturers so that future outbreaks and deaths can be prevented.
Congress has had nearly a year to take common sense steps to address the regulatory gray zone between state authority over pharmacies and federal authority over big, traditional drug manufacturers. These blurred lines sometimes allow the relatively smaller-scale compounding industry to escape sufficient oversight or legally challenge the U.S. Food and Drug Administration’s attempts to regulate it, even as firms ship voluminous amounts of products across state lines.
While pragmatic, thoughtful reforms have been proposed by a bipartisan group of senators that includes Minnesota’s Al Franken, Congress has inexcusably failed to enact any measures to improve patient safety.
This week, a critical opportunity to pass the Senate legislation, which is supported by many respected public health organizations, slipped by. Lawmakers had a crowded docket to get through before the summer recess, and the Senate bill failed to progress. The legislation would give the FDA clear authority over large compounding pharmacies that produce sterile products (such as injectable medications) in advance of a prescription and ship it across state lines.
“This bill recognizes that the industry has changed significantly over the last several decades and attempts to mitigate the risks associated with large-scale production of sterile products … This addresses certain high-risk facilities while leaving traditional pharmacy dispensing essentially untouched,’’ wrote Allan Coukell, the senior director for drugs and medical devices for the Pew Charitable Trusts, in a July 29 letter to Senate leaders.
Another likely and troubling reason for the delayed action on the Senate bill: Some high-profile pharmacy industry advocates such as the National Community Pharmacists Association are trying to delay or weaken it. Action alert letters sent out recently described an FDA power grab and claimed the agency already has the authority it needs to regulate the industry.
On Wednesday, a report released by the nonpartisan Government Accountability Office suggested that these criticisms are off base. The GAO report stated unequivocally that FDA oversight does need to be clarified and recommends that Congress consider doing so. It stated that “gaps in oversight of drug compounding” have occurred as a result of the ongoing questions and disputes about the FDA’s authority.
Lawmakers returning this fall will have another opportunity to take up the Pharmaceutical Quality, Security and Accountability Act, and they should move quickly to make this important safety reform a reality. In the meantime, work should continue on the reforms during this long recess to reconcile the Senate measures with those offered in the House.
The Senate bill contains another critical reform that would enhance officials’ ability to track drugs as they move the supply chain — dramatically improving the detection and prevention of counterfeit drugs.
The respected Minnesota Board of Pharmacy endorsed the Senate legislation at its June meeting. These sensible and overdue drug safety reforms merit strong support from Minnesota citizens and its congressional delegation as well.
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