Federal regulators, trying to head off drug shortages, are poised to release a proposed rule that would require manufacturers to notify them if they stop or delay production of critical drugs.
The rule would require manufacturers to give the Food and Drug Administration six months' notice before discontinuing or interrupting the production of drugs that are life-sustaining, or that treat or prevent debilitating diseases.
"Early notification of supply disruptions or other potential problems that could lead to a shortage will enable the FDA to work with manufacturers and stakeholders to prevent a shortage or mitigate its impact," said FDA spokesman Christopher C. Kelly.
The FDA will consider public comments before finalizing the rule by Jan. 9.
Last year, there were 117 drug shortages, Kelly said, and the FDA was able to prevent another 282, up from 195 in 2011.
Shortages can be agonizing for patients whose lives hang in the balance.
"For many patients, these drugs are life-saving, so the impact (of a shortage) can be tremendous," said Dr. Jack Erban, clinical director of the Tufts Medical Center Cancer Center and professor of medicine at Tufts University School of Medicine. "We don't have the luxury of delaying. It's already extremely stressful to go through chemotherapy. Any deviation is a major source of anxiety and distress for the patient. Occasionally, drugs have to be substituted, sometimes with ones that are not as effective or that have more side effects."
About two years ago, there was a nationwide shortage of Doxil, which is used to treat ovarian, breast and endometrial cancer.
"It affected a lot of women," said Dr. Michael Birrer, director of gynecologic medical oncology at Massachusetts General Hospital and professor of medicine at Harvard Medical School. "We switched to prescribing a parent compound, which is more toxic and not as effective."
Birrer doesn't believe the proposed FDA rule goes far enough.
"Why do we have only one company producing a drug?" he said. "Either we need to stimulate the market by providing a bigger profit margin on generic drugs, or the federal government gets into the drug-making business, which I don't think is smart."
Marjorie Moeling, a spokeswoman for Bedford Laboratories, which makes generic injectable drugs, said, "I can tell you that we understand the urgent need for critical medicines and, in partnership with the FDA, are committed to addressing drug shortage and ensuring our products are safe, effective and reach the people who need them."
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