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FDA responds to shortages of controlled drugs by increasing quotas: 15%.

2020-04-08

photo courtesy of qimono (Arek Socha) via pixabay.com

According to STAT news (statnews.com) the Drug Enforcement Agency (DEA) has responded to reported shortages of certain essential controlled drugs (fentanyl, for example) by increasing quotas.  As I noted on a previous post, Schedule II drugs are produced under a yearly quota system that limits how much can be prescribed and dispensed.  Pharmaceutical companies have responded by cutting back on production of generic versions and increasing the amounts of brand-name, higher-profit versions.  This is from the statnews article:

The agency is increasing production quotas by 15% for several controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine, and pseudoephedrine, as well as certain so-called intermediates that are essential to producing these medicines. The DEA also plans to approve increased imports of ketamine, diazepam, midazolam, lorazepam, and phenobarbital

Because of the pandemic, however, supplies of Schedule II drugs used in patients who are intubated and on ventilators have become very tight.  The percentage of orders fulfilled has dropped.  In response, the DEA ordered increases of their quotas.  This is a .pdf file from fda.gov.

Increases also apply to certain over-the-counter drugs like pseudoephedrine (Sudafed) that are limited due to their possible use as raw ingredients for illicit production of methamphetamine.

Whether this increase will result in an improvement in the supplies of these drugs is an open question.  Reading the DEA order, it appears to be quite tentative– while the demands are great, not to say unprecedented.

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