When American Regent temporarily closed its doors at the end of 2012, a shortage of injectable drugs used in total parenteral nutrition followed. But the FDA announced earlier today that it has a plan in place, assuring that imports would be arriving and available to patients this week.
The ruling reopens the door for other patients to take manufacturers to court if they feel they have been harmed by drug shortages.
There has been 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.
A Florida woman who is now blind in one eye says it is because there was a shortage of Hospira ($HSP) drug Aquasol A that she needed for a vitamin A deficiency. But drugmakers whose poor quality manufacturing leads to closed plants and drug shortages are not responsible for the deteriorating health of patients. At least Hospira is not, a federal judge in Tampa, FL, has ruled.
Cancer docs used the American Society of Clinical Oncology meeting in Chicago on Monday to vent frustration over continuing shortages of cancer drugs.
A shortage of injectable cancer drugs in Canada has been exacerbated by a fire at a Sandoz plant that had already reduced production as it works to fix GMP issues.
"When you have a controlled substance problem, the DEA has to be involved in fixing it," says Ruth Hughes, CEO at Children and Adults with Attention Deficit/Hyperactivity Disorder. Drugs like
Genzyme says that, barring validation and regulatory hiccups, it expects to begin providing Fabry disease sufferers with Fabrazyme produced at its new Framingham, MA, plant beginning the first
We're taking a break between holidays, with our next issue hurtling through cyberspace to your inbox on Tuesday, Jan. 3. That'll be 2012. Our most popular topics this year, judging by the number of
The FDA is "not necessarily the best organization to provide notification on shortages," Ralph Neas told Reuters last week, amid a seeming riot of actions and announcements targeting the prevention