If you’re like some Americans today, you’re looking for a place to fill your prescription for generic medication used to treat attention deficit hyperactivity disorder (ADHD). Or your parent is, since most people who take ADHD medications are actually children and teenagers.
But the U.S. federal agency responsible for the shortage — the Drug Enforcement Agency (DEA) — couldn’t care less.
Even when requested by another agency — the U.S. Food and Drug Administration — to help relieve the shortage, the DEA just turned up their noses.
It’s no wonder voters get so sick of government interfering in their daily lives: One short-sighted federal agency tries to lessen an already minor problem — abuse of ADHD medications by a tiny minority of people — that ends up significantly impacting thousands of others unintentionally.
The New York Times’ Gardiner Harris reported on the problem over the weekend. The DEA is simply in denial of the problem, rather than even trying to work with the FDA to try and resolve it:
“We have reached out to the D.E.A. and told them that there are shortage issues,” said Valerie Jensen, associate director of the F.D.A.’s drug shortage program. “But the quota issues are outside of our area of responsibility.”
Still, Special Agent Gary Boggs of the Drug Enforcement Administration’s Office of Diversion Control, said in an interview, “We believe there is plenty of supply.” [emphasis added]
You know why they believe that? Because there is plenty of supply — of brand name ADHD drugs, but not their generic equivalents.
The DEA’s simple and blissful ignorance of how this can negatively impact thousands of poor, lower-income and even middle-class families who rely on generic ADHD medications is simply astounding.
One stroke of the DEA’s pen is all it would take to fix this problem tomorrow. The problem is one the DEA created after all, because they require drug manufacturers to essentially guess at self-imposed active ingredient quotas they’ll be held to for the year. Then manufacturers get X tons of active ingredients to make Y number of brand-name products and Z number of generic products.
[DEA spokeswoman Barbara Carreno] said that the DEA consults with the ADHD drugmakers annually to determine how much of the “active ingredients” — the amphetamines — they’ll need, and that they can ask for an adjustment later if needed.
“We don’t tell companies how much they can make of any given drug,” she said. “We come up with a quota and then they get their quota,” she said. “A lot of shortages happen when companies miscalculate how much they need of one dosage unit and over-commit some of their active ingredients like amphetamines to, say, 30 milligrams when doctors really want to give 10.”
When the manufacturers mis-estimates the demand for one (in this case, generics), they basically run out of them and can’t make more, because all of the active ingredient is already gone or spoken for. What’s worse, apparently because of the DEA restrictions, manufacturers have no easy way to gain access to more of the active ingredient.
There’s apparently very little flexibility in the DEA regulations imposed upon the manufacturers. All in an attempt to stop the small amount of abuse that occurs because some people misuse the drugs.
All the DEA apparently has to do is say, “Okay, we see there’s a shortage of generic ADHD medications, you can have 10% more of the active ingredient to help alleviate the problem, as long as you only use it to make generics.”
Instead, reminiscent of a “let them eat cake mentality,” the DEA buries its head in the sand and suggests that people who can’t afford name brand prescriptions for ADHD simply go without (or somehow find non-existent money to pay for them):
Ruth Hughes, chief executive of Children and Adults with Attention Deficit Hyperactivity Disorder, a patient advocacy organization, said the drug shortages had become so acute that many patients were going untreated, increasing their risks of deadly traffic accidents and job dismissals. “The consequences of not getting treatment can be devastating,” Ms. Hughes said.
Because despite the potential for abuse of ADHD medications, it’s unconscionable that people who are suffering from ADHD cannot get treatment as a result of stupid regulations that inflexible U.S. federal government agencies will not relax in the face of a nationwide shortage of generics.
Read the full article: F.D.A. Finds Short Supply of Attention Deficit Drugs
Read the blog entry from CommonHealth from November on this issue: Where Have All The ADHD Drugs Gone? Patchy Shortages Abound