Adderall Drug Shortage

News Review:  Atten­tion Dis­or­der Drug Short­age Prompts Fin­ger Point­ing Wall Street Jour­nal 5-5-2011

Recently there has been a short­age of the ADHD drug Adderall, man­u­fac­tured by Shire PLC.  As a result there has been finger-pointing between Shire and the US-Drug Enforce­ment Agency (DEA) as to the root cause.  Shire blames the short­age on DEA lim­its gov­ern­ing the amounts of Drug Prod­uct that can be man­u­fac­tured.  The DEA defends their lim­its say­ing they are ade­quate to allow an unin­ter­rupted sup­ply.  In the mid­dle of this Sen­a­tor Amy Klobuchar (D., MN) sent a let­ter to Shire say­ing that this short­age is forc­ing ADHD med­ica­tion users to switch to more expen­sive branded drugs to com­pen­sate for the shortage.

Adder­all, and most ADHD med­ica­tions are Sched­ule II or III drugs.  There are five lev­els of DEA con­trolled sub­stances, C-I through C-V.  Each clas­si­fied by the chemical’s poten­tial for abuse. All Sched­uled drugs are sub­ject to “quo­tas”, the total amount of drug allowed by the DEA in the US for man­u­fac­ture into Drug Prod­uct.  Each year the DEA pub­lishes a quota defin­ing how much of each drug is allowed in the US.  Each drug man­u­fac­turer must peti­tion the DEA for a share of the quota based on pro­jected yearly require­ments.  Through­out the course of the year, man­u­fac­tur­ers can request an addi­tional quota.  Shire requested addi­tional quota in 2010 but did not receive it until Decem­ber; a con­tribut­ing fac­tor for spo­radic avail­abil­ity. The 2010 amphet­a­mine quota for sale was 18,600,000 grams split between all drug manufacturers.

I have for­mu­lated sev­eral Drug Prod­ucts incor­po­rat­ing C-III drugs.  The DEA has very rig­or­ous pro­ce­dures for mon­i­tor­ing over 350 con­trolled sub­stances.  The paper­work and in-house con­trols for pro­tect­ing these drugs from abuse (theft) is sub­stan­tial. A Drug Man­u­fac­turer must accu­rately esti­mate how much API is required for Drug Prod­uct for com­mer­cial sale; while the DEA must bal­ance how much of a con­trolled sub­stance to allow into the coun­try.  This is a very dif­fi­cult bal­ance to achieve.

The DEA must main­tain tight con­trol over drug lev­els, while the indi­vid­ual drug man­u­fac­tur­ers endeavor to max­i­mize sales.  I believe that the blame for these med­ica­tion short­ages prob­a­bly lies more with the drug man­u­fac­turer, as the DEA states that their quota quan­ti­ties are based esti­mates of the amount of drug needed to allow an unin­ter­rupted sup­ply.  How­ever, in sup­port of the drug manufacturer’s esti­mates, if any­thing goes wrong with the man­u­fac­tur­ing process (failed batch release, API release fail­ure), the needs esti­mates can become wrong very fast.

For addi­tional infor­ma­tion on ADHD in the US, please click the CDC ADHD Data and Sta­tis­tics.