Manufacturers return some drugs to market but shortages persist
There has been some progress on the drug shortages front in the last few weeks with a couple of drugmakers saying manufacturing improvements have allowed them to again meet demand for two critical drugs. But as The New York Times points out, even with new drug shortages popping up at half the numbers of a year ago, there are still dozens of drugs in short supply, forcing some patients to go without essential meds and forcing healthcare providers to make some tough choices.
Just last week, Genzyme said that a new plant was now producing all of the supply needed for its thyroid cancer treatment, Thyrogen. And Hospira ($HSP), which has been at the heart of a number of drug shortages as it works through improvements to its manufacturing plants, said it expects to soon have sufficient supplies to re-enter the market with propofol. The anesthetic is one of the drugs hospitals had turned to the large-sale compounder, Ameridose, for because it was hard to come by. Now Ameridose has closed because of FDA issues, a move that may lead to a number of shortages.
FDA Commissioner Margaret Hamburg told The New York Times that the way the FDA and the industry are now tackling the problem is making a significant difference. While far from resolved, she said, "we're in the midst of a period of really, very significant change that offers great promise for the future." Only about 100 drugs have been added to the shortage list so far this year, compared with 221 when it peaked last year. The FDA says that it has prevented the shortage of about 150 drugs this year by working with the industry to find supplies to avert a potential dearth of a particular med.
Much of the national shortage problem can be traced to production disruptions when drugmakers initiate improvements after the FDA has sent them warning letters. A House subcommittee report earlier this year criticized the FDA for being too aggressive in that regard. However, another House committee recently chastised Hamburg for not acting aggressively enough against the New England Compounding Center. NECC's injectable steroid has been tied to a meningitis outbreak that has killed 33 and infected 460 patients. NECC has common ownership with Ameridose and FDA inspectors recently raised sterility concerns at both plants.
While shortages have been averted, when drugs become hard to get, they tend to remain hard to get, says Erin Fox, who tracks drug shortages at the University of Utah. Her group is keeping an eye on the supplies of 282 difficult-to-come-by drugs, she tells the newspaper. "The shortages we have aren't going away--they're not resolving," she said. "But the good news is we're not piling more shortages on top."
- read The New York Times piece