An investigation by Kaiser Health News into thousands of recent drug recalls reveals a frightening record of medicines in the US being tainted with dangerous bacteria, mold, glass shards, rubber bits, cancer-causing chemicals, mysterious powders, and worrying metal particles. There were also cases of medications with too much or too little ingredients—or simply the wrong ingredients entirely.
Digging deeper, the investigation discovered that a startling number of the drug makers who issued the recalls had received an all-clear from Food and Drug Administration inspectors within a year of their recalls. FDA records and lawsuits suggest that drug makers can easily game the inspection system, mislead inspectors, lie about where drugs are manufactured, or outright sabotage inspections.
For instance, FDA enforcement documents reveal that employees at one drug-making facility in Japan stood “shoulder-to-shoulder” to physically block an FDA inspector from looking around, and another drug maker in India faked a worker strike and cut the lights at its facility to foil an inspection. In a different case, whistleblowers alleged in a lawsuit that Gilead Sciences told the FDA that it used a facility in South Korea to make an ingredient for HIV drugs Truvada and Atripla, but in reality, Gilead was using an unregistered facility in China. The civil suit claimed that the Chinese ingredient contained “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”
In facilities where the FDA does find problems, the agency can send warning letters, but it does not issue fines and lacks the authority to issue mandatory drug recalls.
Though only a fraction of the drugs in the country are recalled and bad-apple manufacturers may be the minority, experts express concern about the overall quality control in the US. “Our drug quality is probably not what we think it is,” Erin Fox told KHN (Fox purchases medicines for University of Utah Health hospitals). The reality, she added, is “scary.”
For its investigation, Kaiser Health reviewed lawsuits, FDA documents, and details of 8,000 drugs recalled since 2013. More than half of those recalls were for drugs made in facilities with FDA citations. But nearly 700 recalls were for drugs made in facilities that had recently passed inspections. The remainder of the recalls were for drugs from facilities that hadnt been inspected in at least five years.
KHNs investigation comes on the heels of highly publicized recalls of widely used blood pressure medications. The medications were recalled after the discovery that they were contaminated with cancer-causing chemicals.
Those drugs were made in overseas facilities, which are often feared for being the source of safety and quality issues. But domestic facilities have also been the source of problems. As an example, the KHN investigation highlighted the case of a Florida facility that produced stool softener later recalled over contamination with Burkholderia cepacia bacteria. The Centers for Disease Control and Prevention linked more than 100 confirmed and suspected infections in 12 states to the drug.
KHN reporters told the story of one of those cases, a six-month-old baby boy in Michigan. He was in the hospital awaiting a heart transplant in 2016 when medical providers gave him the stool softener. He went on to develop a severe respiratory infection with B. cepacia, which landed him in intensive care. His status on the transplant list was put on hold, and his heart condition worsened. He has been on a ventilator ever since. Sharp hospital staff traced his infection—and others—back to the stool softener.
The babys family is now suing the drug maker, PharmaTech, which didnt respond to a request for comment but has denied the lawsuits claims in court documents. Thats despite the FDA investigation in the late summer of 2016 that determined B. cepacia was in the water PharmaTech used to clean its equipment. The FDA concluded that its drugs had been contaminated for a year, and the company issued its recall in August of 2016. PharmaTechs facility, however, had passed a previous FDA inspection in March of 2016.
An FDA spokesperson told KHN that, “While the FDA would prefer that no drug be distributed that later is recalled, we do not think that a recall indicates a failure of FDA inspection and surveillance programs.”