Gaps and Ambiguities in FDA Jurisdiction Fail Consumers

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The FDA's legal standing to mandate reviews and inspect compounding pharmacies has not always been clear-cut. After the meningitis outbreak stemming from a Massachusetts compounding pharmacy, the FDA commissioner is arguing for expanded authority.

This article published with permission from The Burrill Report.

The U.S. Food and Drug Administration is seeking more clear-cut authority over compounding pharmacies after reports revealed that the Massachusetts compounding pharmacy at the center of a national meningitis outbreak showed signs of failing to maintain adequate manufacturing safeguards as early as 2002.

So far, 32 people have died and 461 people have been sickened across 19 states after receiving contaminated injectable products made and distributed by the pharmacy, the New England Compounding Center. Ameridose, a related company, has recalled its entire product line and says it will lay off 700 employees by the end of November.

The FDA conducted three inspections of the New England Compounding Center in the years 2002 through 2006. It issued two official violation reports and one warning letter in 2006, according to information the agency provides as part of the hearing before the House Energy and Commerce Committee.

Nonetheless, the FDA’s legal standing to mandate reviews and inspect compounding pharmacies has not always been clear-cut, the agency says. Facing widespread pressure to more closely watch over compounders now, FDA Commissioner Margaret Hamburg is arguing for expanded authority to more tightly monitor compounders.

“Protecting Americans from unsafe and contaminated drugs is not just an important responsibility of FDA—it is part of our core mission,” said Hamburg in testimony at a November 14 hearing. “Requiring non-traditional compounders to report adverse events, as drug manufacturers are required to do, would allow FDA and the states to identify trends and to proactively take steps to curtail dangerous compounding practices.”

Compounding pharmacies have proved to be a lucrative business niche, as hospitals and other healthcare providers have in some cases sought to control costs by working with compounders, which can in some cases prepare drugs at lower costs than alternative sources because of their lower regulatory overhead. Federal oversight though has failed to keep pace with the industry’s growth, leaving a web of rules governing compounders that can differ from state to state.

“It is really unfortunate that it takes a crisis to bring this kind of change,” says Deborah Autor, FDA deputy commissioner. “But that is often the case.”