Analysis: Compounding Crisis Leaves Regulators With Few Good Options

| 23 October 2012 |  By 

Extensive problems with a compounding pharmacy in Massachusetts have left US regulators in a complicated bind: They can err on the side of caution and shut down the company's sister organization until it receives regulatory approval, but doing so would likely exacerbate drug shortages already near record highs thanks to similar shutdowns related to regulatory deficiencies in larger pharmaceutical establishments.

The owners of the New England Compounding Center (NECC), the company whose products are now at the center of a burgeoning crisis involving patients made ill by fungal meningitis, also own another compounding pharmacy known as Ameridose. That company has been closed since early October as FDA investigators try to ascertain whether the same fungus that has infected several products manufactured by NECC is present in any of Ameridose's products.

But the challenge, as explained by the American Enterprise Institute's (AEI) Scott Gottlieb, former deputy commissioner of FDA, is that agency regulators are increasingly finding themselves in a pernicious feedback loop.

The shorter version: As regulators crack down on poor manufacturing practices with the potential to harm patients, drug shortages start to occur. These drug shortages harm patients, but also lead prescribers to look for alternate suppliers for the now-scarce drug products. These products are increasingly manufactured either by companies abroad, which are under less scrutiny than their US counterparts, or by compounding pharmacies, which are not subject to strict FDA oversight. Occasionally, the poor manufacturing practices of these companies lead to a crisis-as in the case of NECC-requiring FDA intervention and causing further drug shortages.

The cycle, in other words, is vicious, and leaves few good options available to regulators hoping to get a handle on what is essentially a lose-lose proposition for them. Either they don't take action against poor manufacturing practices, which can lead to patients being harmed by contaminated products or worse, or they do take action and harm patients by denying them of necessary drug products or driving them to use even worse products.

Long-term lack of oversight can lead to serious problems as well. Both the New York Times and Wall Street Journal report that concerns about NECC were raised as early as 1999, and frequently since then. Earlier interventions might have avoided the current crisis, the articles imply.

But such interventions may only have served to benefit NECC's even-less-scrupulous competitors. A separate New York Times article said compounding pharmacies have increasingly been linked to the import of foreign-sourced raw materials, much of which lacks FDA approval. By increasing inspection costs on compounding pharmacies, it is entirely feasible that regulators may just drive them to seek cheaper and less regulated materials in an effort to stay competitive based on the price of their offerings.

Ultimately, FDA regulators are left in a difficult-and largely reactive-situational bind, and one where answers may be elusive in the absence of more funding for an agency increasingly stretched thin.


© 2022 Regulatory Affairs Professionals Society.

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