Drugs can end up on the FDA shortage list for many reasons, with manufacturing problems and recalls often being the culprit. But a new report says that for more than a decade, poor management by the Drug Enforcement Agency and a touchy relationship between the DEA and FDA have been at the heart of many shortages of controlled substances.
On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.
Japan's Eisai, which lashed out this week at the U.K.'s cost watchdog as too restrictive, has lost its bid to force the DEA to schedule Fycompa so it can get it launched in the U.S. The seizure drug was approved by the FDA a year ago.
Eisai has had it with the Drug Enforcement Administration. The Japanese drugmaker won FDA approval for its new seizure drug, Fycompa, last October. But the DEA still hasn't done its part by classifying it as a controlled substance--and that means the drug can't launch.
The DEA has made its decision on Belviq, the weight-loss drug that's been sitting on Arena's launching pad since its FDA approval last June. Belviq is now officially a Schedule IV controlled substance, and Arena can fire up its engines for a launch next month.
Arena Pharmaceuticals has decided to take its drug application and go home. The drugmaker Friday said it was giving up for now on breaking through the European wall of resistance to its weight-loss drug Belviq. The company, which got FDA approval last year, yanked its application with little explanation.
The FDA is enmeshed in a process to find the right balance on how to approve and regulate addictive painkillers and a vote expected today is just one small piece of that puzzle-piecing exercise.
"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
In yet another object lesson about the complexities of drug shortages, The New York Times takes a look at scarce ADHD medications. Anyone who's been following the ongoing drug-shortage mess knows
Unexpected changes in the physical-chemical properties of an API or excipient are often the culprit behind drug shortages. However, the changes are difficult to resolve. "Sometimes the cause may be