April 6, 2016
State Should Close Down Dangerous Texas Drug Maker That Ignores FDA
Compounding Pharmacy Continues to Sell Medications After Receiving Warnings for Serious Violations
WASHINGTON, D.C. – The Texas State Board of Pharmacy should immediately suspend the license of an Austin-based compounding pharmacy – and the licenses of its pharmacists, including Pharmacist-in-Charge Carlos H. Garcia – for repeatedly and knowingly violating standard procedures for producing sterile injectable medications, Public Citizen said in a letter today.
Within less than two years, I.V. Specialty – a compounding pharmacy that produces a wide range of sterile medications for patients located within a two-hour radius of Austin – has failed two U.S. Food and Drug Administration (FDA) inspections. The company refused to follow the FDA’s recommendations last month to discontinue production of the injectable medications and to recall all of its unexpired products on the market.
“The FDA’s inspections discovered that medications produced at I.V. Specialty are made under unsanitary conditions and without adherence to all necessary procedures,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The State Board of Pharmacy urgently needs to take action to protect public health. Such potentially tainted medications must never be given to patients.”
I.V. Specialty was first inspected in July 2014. At that time, FDA investigators identified numerous “serious deficiencies” in the company’s practices for producing sterile products. A belated warning letter was sent to the company in April 2015 indicating that these deficiencies “put patients at risk.”
The FDA reinspected the company from Jan. 25 through Feb. 5, 2016, and once again uncovered egregious problems. For example, the gowns worn by workers were not sterile, the equipment and processing rooms were not properly cleaned and disinfected, and the products made were not tested to prove they were sterile before being released to patients.
The FDA lacks authority to order I.V. Specialty to recall its injectable products or to force the company to stop production without undertaking a lengthy legal process. On March 7, the FDA recommended that the company take these actions voluntarily, but the company refused.
So on March 9, the FDA issued an alert to health care providers and patients not to use I.V. Specialty products that are intended to be sterile.
“Companies should not have the freedom to continue manufacturing and selling dangerous products, posing a threat to patients. The FDA’s warning to health care providers is simply not enough,” said Carome. “Last month, the Alabama State Board of Pharmacy ordered a compounding pharmacy to cease production of sterile drugs because of a situation remarkably similar to I.V. Specialty. Now it is time for the Texas State Board of Pharmacy to act.”