FDA to Take Enforcement Action against Companies Marketing Unapproved Oxycodone Drugs

Jul 17, 2012   

On July 5, 2012, the U.S. Food and Drug Administration (FDA) announced its intent to take enforcement action against companies that manufacture and distribute certain unapproved drugs that contain oxycodone. The notice is part of the FDAs Unapproved Drugs Initiative to remove unapproved new drugs from the market. The full text of the announcement can be found here.

The FDA action affects companies manufacturing and distributing unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. The FDA states that these products have not been evaluated for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings. Therefore, these products cannot be marketed legally in the United States.

The FDA is concerned because the oxycodone drug products pose a risk to public health due to the omission of important warning information on the labeling. The FDA is aware of two serious adverse events: (1) a 21-month-old patient prescribed oxycodone at a strength of 1 mg/mL but instead given one at 20 mg/mL who suffered respiratory failure but was successfully resuscitated; and (2) an 18-year-old patient whose prescription was to take one 5 mg teaspoon every four hours but was given a 20 mg/mL solution. The second patient went into a coma with organ failure and was placed in intensive care.

Companies that manufacture the oxycodone drug products are expected to cease production within 45 days of the notice and halt shipping the products within 90 days. The oxycodone drug products that are subject to these timeframes include products that:

  • were introduced onto the market before September 19, 2011, 
  • were listed in the FDAs Drug Registration and Listing System before July 6, 2012, and 
  • were being commercially used or sold before July 6, 2012.

Generally, the FDA will issue Warning Letters to companies before taking enforcement action. However, the FDA stated that in this circumstance it will not issue Warning Letters before taking enforcement actions against companies that continue to market, manufacture, or ship the oxycodone drug products. Companies that continue to market, manufacture, or ship are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding.

For more information about FDA enforcement action or regulatory compliance, please contact us at contact@fidjlaw.com.