Inside a drug shortage: Finding answers in FDA inspection reports

Photo by Dreamstime

Peter Loftus of Dow Jones Newswires was all over the Doxil shortage last year. He started in July writing about insufficient supplies of the cancer prescription drug after learning the manufacturer had sent doctors letters asking them not to start new patients on the drug, he says. A month later, he learned the shortage still existed and that a waiting list had begun.

“Once it became clear it was a persistent shortage, I felt like there needed to be more of an explanation than what we’d gotten,” Peter says. “It was driven by a human reaction to the idea that patients were being told there was a drug that might help, but there wasn’t enough of it so they had to go on a waiting list.”

Peter Loftus

He says his readers also wanted to know because of the impact on sales and financial results. “I wanted to get as many answers as possible,” he says.

Food & Drug Administration inspection reports provided many answers. Peter says FDA Form 483 offers details about inspections. He says the only way to know they’ve been completed is through sources or if an FDA warning letter has been posted.

He initially requested FDA inspection reports for the contract manufacturer’s site after learning the Canadian regulatory agency had found deficiencies, he says. He requested an additional report when the European Medicines Agency publicly said it had conducted a joint inspection with the FDA, he says.

Peter’s coverage continued through December with breaking news pieces and other articles including one looking at the shortage’s impact on clinical trials. He says reporters can get more information about clinical trials at the National Institutes of Health’s Clinicaltrials.gov site. He found patients taking the drugs by locating doctors who treated the types of cancer specified for the drug.