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Outrage of the Month: A Dangerous Drug Maker Ignores the FDA
Health Letter, April 2016
Michael Carome, M.D.
Bacteria or fungi, the consequences can be catastrophic. For example, in 2012 to 2013, the nation watched in horror as more than 750 patients across 20 states were sickened with fungal meningitis and other serious infections after receiving injections of contaminated steroids produced by a compounding pharmacy in Massachusetts. Sixty-four of those patients died.
The discovery of injectable drugs made In February, an inspection of a compounding pharmacy in Texas by the Food and Drug Administration (FDA) found multiple serious violations of standard procedures for producing sterile injectable drugs. The company was a repeat offender, having failed a similar FDA inspection two years earlier. Shockingly, the company thumbed its nose at federal regulators by refusing to follow recommendations to discontinue production of injectable drugs and to recall all of its unexpired injectable drug products.
When patients are injected with supposedly sterile drugs that turn out to be contaminated with under unsanitary conditions and without adherence to all necessary procedures demands urgent action to protect public health. Such potentially tainted drugs must never be administered to patients.
I.V. Specialty — a compounding pharmacy based in Austin that produces a wide range of sterile drugs — voluntarily registered with the FDA as an outsourcing facility in February 2014. By doing so, the company agreed to adhere to FDA-mandated standards for manufacturing sterile drugs and to undergo periodic FDA inspections of its facility.
The FDA first inspected I.V. Specialty in July 2014. At that time, FDA investigators identified numerous “serious deficiencies” in the company’s practices for producing sterile drug products. In a belated warning letter sent to the company in April 2015 — after it was no longer registered with the FDA as an outsourcing facility — the agency indicated that these deficiencies “put patients at risk.” The FDA’s warning letter hammered home this point by stating that “drug products compounded in [the company’s] facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.”
Even though I.V. Specialty is no longer a registered outsourcing facility, the FDA, invoking its authority to inspect any facility that makes or sells drug products, wisely reinspected the company from Jan. 25 through Feb. 5, 2016. Once again, the agency uncovered multiple egregious problems in the company’s processes for making sterile drugs.
Lacking the authority to order I.V. Specialty to recall its injectable drugs and being unable to force the company to cease operations without undertaking a lengthy legal process, the FDA on March 7 recommended that the company take these actions voluntarily, but the company refused to do so. Therefore, to protect patients from the risk of life-threatening infections, the FDA on March 9 issued an alert to health care providers and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty.
I.V. Specialty is not the first compounding pharmacy to disregard calls from the FDA to recall injectable drugs produced under unsanitary conditions. A similar scenario played out from 2013 to 2015 between the FDA and Downing Labs (formerly NuVision Pharmacy) in Dallas. Companies should not have the freedom to continue manufacturing and selling dangerous drugs, posing a threat to patients.
To address I.V. Specialty’s noncooperation in the short term, the Texas State Board of Pharmacy should suspend immediately the company’s pharmacy license and the licenses of the company’s pharmacists. Without these licenses, the company cannot continue to operate legally.
In the long term, it is imperative that Congress pass legislation giving the FDA the legal authority to order immediate recalls of any drug product that the agency deems to pose an immediate threat to public health. Until such authority is granted, it is only a matter of time before the nation experiences another outbreak of preventable serious infections from tainted injectable drugs.