Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

In order to launch a CII product you have to apply for a quota from the DEA, but you cannot apply for a quota until approval. This request can take several weeks sometimes

Here is just one example from last year. In the midst of a national shortage of IV pain meds in hospitals, it took the DEA 6 weeks and 10 weeks, respectively, to grant additional quota to alternate manufacturers. And that was during a crisis situaton that was affecting patient care and causing surgeries to be cancelled. The shortage was caused in the first place because DEA drastically cut national quotas in 2017 and 2018 without any change in demand or prescriptions. I doubt there was any oxycodone or hydrocodone quota remaining for 2018 by the time we got ANDA approvals. It seems to me the quota is the important part. Launch date is irrelevant compared with the quota amount. A company will most likely manufacture and sell 100% of their quota. Drugdoctor hinted at this the other day. He frequently has supply problems with CII drugs and has to use alternate suppliers. This is the quota system at work. Maybe it's not who you know at the FDA but rather who you know at DEA.



https://www.modernhealthcare.com/article/20180414/NEWS/180419944


DEA lifts production quotas to ease injectable opioid shortage
By Alex Kacik | April 14, 2018

Requests for additional raw ingredients were made to the DEA Jan. 1, but partial approvals for Fresenius Kabi and West-Ward Pharmaceuticals, along with a third smaller and unidentified manufacturer, weren't granted until mid-February and mid-March. The process highlights the difficult balance regulators must strike between limiting the opioid epidemic and getting pain medication to critically ill patients. Regulatory hurdles can also throw a wrench in the entire process.

Meanwhile, providers have had to scramble to find adequate alternatives that can sedate patients before surgery and manage pain after an operation as well as treat trauma, burn and cancer patients. Or, in some cases, they have had to put off treatment altogether.

"I am shocked that the DEA raised the quota only three weeks ago after being notified of the significant shortage and inability of Pfizer to ship product," said Erin Fox, who directs the University of Utah's Drug Information Service, adding that it takes time for manufacturers to ramp up production. "The shortage was well known to the DEA, so I am unclear on why it took so long to increase the amounts to other manufacturers."