Saturday, December 31, 2011

Ritalin and Adderall shortages -- the DEA and the other side of outrage

Beyond outrage, there is a point where we can only laugh and cry...

F.D.A. Is Finding Attention Drugs in Short Supply - NYTimes.com

... While the Food and Drug Administration monitors the safety and supply of the drugs, which are sold both as generics and under brand names like Ritalin and Adderall, the Drug Enforcement Administration sets manufacturing quotas that are designed to control supplies and thwart abuse. Every year, the D.E.A. accepts applications from manufacturers to make the drugs, analyzes how much was sold the previous year and then allots portions of the expected demand to various companies.

How each manufacturer divides its quota among its own A.D.H.D. medicines — preparing some as high-priced brands and others as cheaper generics — is left up to the company.

Now, multiple manufacturers have announced that their medicines are in short supply. The F.D.A. has included these pills on its official shortages list, as has the American Society of Health-System Pharmacists, which tracks the problem for hospitals. And the American Academy of Child and Adolescent Psychiatry has told the more than 8,000 doctors in its membership that shortages seem to be “widespread across a number of states” and are “devastating” for children.

Officials at the Food and Drug Administration say the shortages are a result of overly strict quotas set by the Drug Enforcement Administration, which, for its part, questions whether there really are shortages or whether manufacturers are simply choosing to make more of the expensive pills than the generics, creating supply and demand imbalances...

Let us set aside the trivial matter. Drug company CEOs would sell their mother's liver to "meet expectations". I'm sure they're exploiting every legal and even semi-legal angle they can find in an age where patents are expiring and the drug pipeline is dry.

That's not the problem though. Just think for a minute about how this is supposed to work. The DEA wants to stop the recreational use of stimulant drugs. They do this by restricting the supply. So recreational use will stop because one of two things happen. Maybe the drug companies, who get paid either way, will start assassinating stimulant dealers. Alternatively, parents of kids with ADHD will put on capes and masks and start beating up college kids prepping for exams.

Yeah, think about that. How else are these DEA restrictions supposed to work?

Now if you're a relatively young person you may be thinking senior leadership at the DEA couldn't really be this stupid. Trust me, powerful people are often stupid. It's almost a prerequisite.

It's time to contact Senators and Representatives. Again. Here's what I'm sending Al Franken and Amy Klobuchar..

Dear Senator

I read in the New York Times that DEA quotas on stimulant drug production are leading to shortages of critically important medications for the treatment of ADD and related disorders.

I understand that the DEA has set these quotes to motivate parents of children with ADHD to prevent the recreational use of stimulant medications. I assume we're supposed to don costumes and start pummeling stimulant dealers to reduce diversion.

Please ask the head of the DEA to explain to you and all of us how their production quotes are supposed to work. In detail. Repeatedly. Until they get a clue.

Thanks very much...