What would you do if you had to decide whether to give a suffering patient morphine, but weren’t sure whether there’d be be enough left for the next patient, who might need the painkiller more? A nationwide drug shortage has forced health care workers into making these difficult decisions — and some are even choosing to treat patients with less effective or expired drugs.
Although this problem first rose to national attention in 2011, shortages of even the most basic drugs continue. While many patients are feeling the squeeze and suffering the effects on an ongoing basis, in fact the lack of a key drug can affect any of us at any time, unpredictably.
Drug companies — especially generic drugmakers — and the FDA, have sought to blame delays at plants that make sterile injectable drugs, due to closings of the plants for quality control. The FDA says that these delays may be to blame for 80 percent of the shortages, while some blame the FDA itself for exerting too much control, slowing production in plants or closing plants unnecessarily.
Erin Fox, who works with the University of Utah’s Drug Information Service, said that 282 drugs were in short supply in the third quarter of this year, a record high. “The shortages we have aren’t going away — they’re not resolving,” she said. This is despite the fact that Margaret Hamburg, the head of the FDA, has been bragging about how they prevented 150 shortages this year.
ACSH’s Dr. Josh Bloom, who has written about this issue in the pages of the New York Post, doesn’t buy the happy talk. He says that the Department of Health and Human Services and the FDA can pat themselves on the back all they want, but the principal reason for the shortage remains the same — prohibitive price controls on Medicare reimbursements forced upon the generic drug industry by Congress in 2003. He notes, “The truth is that whatever the FDA does or doesn’t do, it does not get to the root of the problem. If there was a decent profit to be made by manufacturing these cheap generics there would be plenty of companies making them. Then we wouldn’t be dependent upon foreign importation of substandard drugs made by questionable manufacturers. You cannot have artificially cheap drugs and a constant supply stream — they are mutually exclusive.”
In the end, it is the patients who suffer. The FDA has approved certain drugs for production that would have been recalled if there was no shortage. A chemotherapy drug manufactured by American Regent was shown to contain glass particles, but was allowed to be used because of the short supply, as long as the drug was filtered before use. It has come down to this, according to Dr. Sandra Kweder, deputy director of the FDA’s office of new drugs: “If there wasn’t a shortage, we would never allow a company to continue marketing…but patients need it.”