The FDA's latest action, involving bacterial infections potentially associated with a compounding pharmacy's product, shows the Pharmaceutical Quality, Security, and Accountability Act should be enacted, the HELP chairman said.
FDA announced the recall had followed reports of bacterial bloodstream infections potentially related to Specialty Compounding's calcium gluconate infusions. Facilities, health care providers, and patients who received them since May 9, 2013, "should immediately discontinue use, quarantine the products, and return the products to Specialty Compounding," the agency announced.
Harkin's statement said 15 patients developed infections. "Though this case is still under investigation by the FDA, this latest in a string of incidents involving compounders brings renewed focus to the U.S. Senate's bipartisan Pharmaceutical Quality, Security, and Accountability Act," it said. "The legislation would improve the safety of compounded drugs by making clear the compounding oversight responsibilities of state and federal authorities. The bill would also protect the nation's drug supply chain by establishing a uniform, national prescription drug-tracing framework. It was approved by the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee in May, and is now pending consideration by the full Senate."
"I am saddened to learn of yet another incident where patients have been potentially harmed due to tainted drugs produced by a compounder," he said. "The Senate has before it a unique opportunity to take bipartisan action and improve the safety of compounded drugs. I hope that the Senate takes up and passes the bipartisan Pharmaceutical Quality, Security, and Accountability Act as soon as possible so that the FDA and state boards of pharmacy can have the guidance necessary to carry out their work to protect all Americans."
"Because of the potential association between the hospital-based infections and sterile compounded medications produced by Specialty Compounding, we are voluntarily recalling all sterile products out of an abundance of caution," Ray Solano, R.Ph., pharmacist in charge at Specialty Compounding, said in an FDA news release. "We deeply regret the impact this recall has on our patients and the hospitals that we serve, but patient safety must always be our first concern."