Product News and Recalls

FDA To Expand Authority Over Drug Compounders

Recently, the FDA advocated to expand authority over drug compounders due to a recent increase in public health risks caused by these facilities.

Traditional compounding pharmacies have been used for over a century to provide a customized prescriptions for patients. A recent trend, however, is that these compounders have started acting as large-scale manufacturers for medical facilities across the country, raising new concerns about safety and proper regulatory oversight.

An editorial in USA Today describes one of these mounting health risks: a meningitis outbreak caused by a steroid shot for a pinched nerve. This shot was linked to contaminated injections made by the New England Compounding Center (NECC).

The FDA found dozens of safety problems at large-scale compounders across the USA, and to date there have been dozens of recalls [links to our posts] and over 700 people in 20 states that have been hospitalized.
Following this public health disaster, members of Congress are currently discussing the following:

  • Has the Food and Drug Administration failed to use its existing authority to oversee compounders such as NECC?
  • Does the FDA need broader powers?

Now, it seems the FDA and other health officials knew of these problems caused by the NECC’s products, and that little action was taken toward the foreseeable harm that would follow. Recently, the FDA Commissioner stated the “agency should have more aggressively applied existing authorities, and that large-scale compounders should have to register with the FDA, meet uniform quality standards, label their products, report any adverse drug reactions and be barred from producing certain medications.” Based on the widespread failure in quality control at large-scale compounding facilities, it seems that clear that more oversight is necessary to protect consumers.

The article states that the Senate has looked into these problems twice within the past 10 years, and hopefully now by working alongside Congress and the FDA these proposed solutions can take be placed into action.