Hospitals and outside companies routinely transform solid drugs into injectable form, or “compound” them, as a way to preserve their shelf-life and stretch supplies amid drug shortages. But compounding requires sterile conditions to avoid tainting the remixed drugs. At least 53 people died last fall after contaminated drugs mixed by the New England Compounding Center were given to patients in 20 states.
Usually, the hospitals that use compounded sterile drugs buy them from vendors such as the 31 the FDA has inspected since February, rather than doing the compounding in the hospital pharmacy.
But a survey from HHS' inspector general's office released last week shows that hospital officials are alarmed by the meningitis outbreak, and that they didn't wait for the FDA inspections to start re-examining their drug supplies. More than half of surveyed hospitals have already quizzed their suppliers about product quality, and more than 40% have switched pharmacies altogether.
Despite the widespread concern, FDA officials said they hit barriers when they tried to inspect some compounding facilities.
At least four of the compounding firms initially refused to grant the inspectors access to their records, and in two other cases, inspectors had to obtain administrative warrants and be accompanied by U.S. marshals to execute the searches, according to a blog post by FDA Commissioner Dr. Margaret Hamburg.
Last November, Hamburg told the members of the House oversight committee during their first hearing on the outbreak that the FDA lacked adequate legal tools to inspect compounding pharmacies, which she said operate under outdated rules. She urged Congress to give the FDA “clear, full authority” to collect samples and examine internal records at compounding pharmacies.
House oversight subcommittee Chairman Rep. Tim Murphy (R-Pa.), said the public deserves an explanation from the FDA as to how the meningitis outbreak was allowed to take place.
“The evidence so far demonstrates the NECC should have been shut down long before 50 people tragically lost their lives from contaminated injections,” Murphy said in a news release. “The FDA owes the American public the peace of mind that it will do all it can to protect the integrity of the nation's drug supply chain, and the goal of our investigation is to ensure that happens.”
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