Late News: Safety woes

Air filters marked with dark-amber stains, unexplained variations in drug purity, patients' complaints dismissed without investigation: all were among the deficiencies cited at 31 drug-compounding factories inspected in the past seven weeks by the Food and Drug Administration.

In the wake of last year's deadly outbreak of drug-borne fungal meningitis, the FDA has undertaken an aggressive inspection program at higher-risk facilities around the country that produce the sterile compounded drugs on which many hospitals rely.

As of April 11, all of the reports were available online, documenting conditions so severe that in some cases the firms voluntarily recalled products or temporarily suspended production while they corrected deficiencies found by investigators. The companies were selected for “proactive” inspection based on past adverse event reports, historical inspection data and reports of quality problems.

On April 16, the House Oversight and Investigations Subcommittee is scheduled to hold its second hearing examining the meningitis outbreak, specifically probing the question of whether the outbreak caused by injected compounded drugs could have been prevented.

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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