U.S. officials, docs step into drug-shortage fray

The U.S. drug supply needs emergency treatment. With record numbers of drugs running short, officials are casting about for solutions, stat. While a group of lawmakers is pushing legislation that would require drugmakers to report potential shortages early, the Obama administration is taking a page out of the disaster-prep handbook. Just as the Centers for Disease Control and Prevention stockpiles antibiotics and other highly necessary drugs in case of an earthquake or attack, the government would stock up on cancer meds that have run dangerously scarce this year, the New York Times reports.

Meanwhile, a group of oncologists disgusted by their inability to obtain common-and-essential treatments for their patients have started a nonprofit group to import the drugs at first--and then manufacture the medications themselves. "We have a meeting with the FDA next week," Dr. George Tidmarsh, a pediatric oncologist, told the Times. "This unfolding tragedy must stop, and right now."

The shortages have become big news in the mainstream press. Stories of patients unable to get treatment for their cancers have popped up all over the country. The litany of reasons for the shortages--manufacturing snafus, capacity constraints, low profit margins--is familiar by now. For one or several of those reasons, 180 meds have made it onto FDA's list of scarce products.

The Times story, however, points out a couple of wrinkles. Mylan's ($MYL) Heather Bresch, who's been advocating generic drug user fees that would finance overseas plant inspections, blames the shortage of FDA inspectors for the problem. If inspectors were available to clear foreign plants, then a greater number might be turning out these scarce drugs, she says. And a Johnson & Johnson ($JNJ) spokeswoman, explaining a shortage of the company's cancer drug Doxil, faulted capacity constraints at a third-party manufacturer--which raises the question of whether outsourced manufacturing is contributing to the problem.

- read the NYT story

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