New supplies of two unavailable cancer drugs will be allowed by the FDA.
Dow Jones Newswires(DJN) reports that the FDA will allow the temporary importation of Lipodox as a substitute for Johnson & Johnson’s Doxil. The drugs have the same active ingredient. Doxil has been in short supply since about mid-2011. New supplies of Lipodox are “expected to end the shortage and fully meet patient needs in the coming weeks,” the FDA says.
The FDA has also approved a new manufacturer, APP Pharmaceuticals, of preservative-free methotrexate, a drug that is used to treat a type of children’s leukemia and has also been in short supply. The drug should be available in March. The agency “is actively working with other manufacturers … including Mylan and Sandoz Pharmaceuticals” to meet patient needs.
DJN notes that both shortages can be traced back to the closing of a Ben Venue Laboratories plant in Ohio. Ben Venue, a unit of Boehringer Ingelheim, shut down the plant to deal with manufacturing issues. See here.
The GAO just issued a report that stated the majority of drug shortages now being seen were due to manufacturing problems. See WSJ article.
While the Pharmalot blog reports that more than two dozen patients who suffered due to drug shortages filed a lawsuit today in DC federal court against the US Dept of Health and Human Services (DHHS), the FDA, and NIH. The suit argues that FDA licenses to drugmakers that cuase shortages should be invalidated and their patents declared unenforceable (how did they miss the patent office in suit too?).
The poster boy for this suit is Genzyme with its celebrated manufacturing issues at the Allston plant which caused repeated delays in the supply of both Cerezyme and Fabrazyme (which is still not back to normal).
Posted by Bruce Lehr Feb 21st 2012.