For much of the past year, various meds for attention deficit hyperactivity disorder have been in short supply. The lack of pills, such as Ritalin and Adderall XR, have caused a highly disruptive problem for children and their parents, much like the ongoing shortages of generic injectable medications have wreaked havoc at hospitals and clinics (
back story).
However, the dearth of ADHD pills has engendered a fingerpointing blame game between two federal agencies. The FDA says the shortages are due to unnecessarily strict quotas set by the US Drug Enforcement Agency. In turn, the DEA suggests drugmakers may be at fault for making more of the higher-priced brand-name versions than generics, which throws supply and demand out of whack.
“We have reached out to the DEA and told them that there are shortage issues, but the quota issues are outside of our area of responsibility.” Valerie Jensen, associate director of the FDA drug shortage program told The New York Times recently. But DEA Special Agent Gary Boggs, who works in the Office of Diversion Control, argued that "we believe there is plenty of supply.”
Indeed, Novartis sells brand-name and generic versions of Ritalin, while Shire does the same for Adderall XR. Both companies have insisted they have attempted to meet demand while working with the DEA on quotas. But the confusion has irked some members of Congress and now four House Democrats have written the DEA and the drugmakers to improve supplies and availability.
The letters to the drugmakers charge that supplies of the brand-name versions may be given preference over the generics, which can yield lower profits, but "the effect of this policy could be to force consumers who need (Adderall XR or Ritalin) to pay for an expensive brand-name product rather than a less-expensive generic drug" (here is the letter to Shire ceo Angus Russell and the letter to Novartis ceo Joe Jimenez.
And so the Democrats - House Energy and Commerce Committee ranking member Henry Waxman; Subcommittee ranking members Diana DeGette and Frank Pallone, Jr., and Budget Committee Ranking Member Chris Van Hollen - want the drugmakers to cough up info on DEA quotas; actual production output; wholesale acquisition cost data; Medicaid reimbursement figures and internal documents on policies concerning production of the brand-name and generic ADHD meds.
Similarly, they asked the DEA for information on how it sets quotas for the pills; any analysis the DEA has conducted to determine availability and why patients have reported difficulty obtaining the meds; a summary of the effect that quotas have had on supplies; a report on the extent to which the DEA considers business decisions when setting quota policies, and any changes the DEA may consider.
"We consider data from many sources when we look at quotas. What most people don't realize is that we don't issue quotas for products, we issue the quota for the active ingredient, which is amphetamine salt... We look at legitimate medical needs, prescriptions dispensed, manufacturer disposition and forecasts, our own tracking data from wholesalers. We actually increased quota for amphetamine salt by 30 percent for 2012," DEA spokesman Rusty Payne tells us.
"We've always maintained there was enough quota available. What we saw was a depletion of reserves. Manufacturers are allowed to carry over any excess, but that was becoming depleted, hence the increase in quota. We still maintain these companies have multiple products and its their decision how to allocate production and those are business decisions. We don't get involved in that nor should we. And we don't control those decisions."
A Novartis spokeswoman writes us to say that the drugmaker has received the letter. "We take this matter seriously and intend to cooperate fully with the inquiry. We are also working diligently to increase supply of our generic ADHD medicines to meet customer demand and are committed to helping ensure the appropriate patients have the ability to fill their prescriptions."
We have asked Shire for comment and will update you accordingly. Meanwhile, a spokeswoman for the House Energy and Commerce Committee says similar letters may go out to drugmakers that sell still other ADHD meds if reliable information becomes available to suggest that product shortages for those meds also exist.
11 Comments
More grist for the political mill...
Those who argue that regulation (even if regulators are themselves at odds) is keeping "life-saving medicines" from the people. Versus those who say that industry manipulation of market supply is the key.
Justice in MI prediction: Look forward to pac-sponsored ads featuring hyperkinetic regulators running into each and stepping on/over crying, disoriented children.
You know that Big Pharma and Big Govt have both grown too big when you read there is a 'associate director of the FDA drug shortage program'.
If the only people taking ADHD meds were those patients who actually need the meds for diagnosed ADHD there would be no shortage. The shortage is in large measure duer to overprerscription of these drugs to college students to pull three straight all nighters and/or sell them to their fellow students, or better yet to the professors for whom they can extract a higher street value.
I don't know how it impacts the "shortage," but OII is right that pill mill docs/whores have been pushers for ADHD drugs to students, their parents, and their teachers.
Grotesque.
I'm sure they are *shocked* at Novartis to hear such lies about drug pushers - shocked! I tell you...
I should have creditid JiM for the college observations since it was JiM who first brought this to our atttention.
"The lack of pills, such as Ritalin and Adderall XR, have caused a highly disruptive problem for children and their parents, much like the ongoing shortages of generic injectable medications have wreaked havoc at hospitals and clinics."
Uh huh. So a shortage of amphetamines for children is now a national emergency. How in the world can one equate shortages of an actual life saving drug with this nonsense? Yes, it is disruptive for parents who would rather drug their children into submission rather than take an active role in kid's lives. Yes, it is disruptive for drug manufacturers who won't be able to hit their sales targets. Disruptive for the kids? Doubtful, has anyone actually asked them how the feel about being forced to take mind-altering psychotropic drugs?
Speed had been around for a century, yet parents didn't feel the need to give it to children a generation ago. Two decades ago, amphetamine shortages meant the local meth lab had been busted. But then, we were "self medicating" because we too had ADHD, but didn't realize it. I was actually told this by a pediatrician, trying to justify prescribing meds for my five year old.
Of course the shortage of any drug is newsworthy and certainly appropriate for a pharma blog. That being said, it would be more credible if done without including the CHADD and NAMI talking points as articles of faith. In a sane world, amphetamine shortages would be viewed as a godsend, not a crisis.
My father died of stage 4 metastatic liver cancer. Ten weeks before his death a PA expressed concern about his use of straight oxycodone, XR + IR rescue doses totalling 40mg/day. The fellow said he had other oncology patients detoxing. Wanted my dad back on the Lortab, you know the stuff with acetaminophen.
The military intelligence of the drug war. With 95% of his liver cooked let's get him back on the stuff that's toxic to the liver. And God forbid we get him addicted to the oxycodone. Pain's good for the soul.
Isn't morality wonderful: "In a sane world, amphetamine shortages would be viewed as a godsend, not a crisis."
Ok, I'm talking apples and oranges, opioids and psychostimulants. But while there is abuse of both, there is rational use, legitimate benefit of both. But some see only the abuse, and generalize use as abuse. In this world, morality always trumps compassion. They write of "pill mill whores" and "kids taking mind altering psychotropic drugs" by "parents who drug [their] children into submission." I imagine these people don't have ADHD: they haven't experienced the stresses and failures of being untreated and lived the nonsense of their folk psychology. (Funny how parents can have both kids with and without ADHD if deficient parenting is the cause.) Had I been treated as a child my life would be different.
Back to reality, in any other business setting, producing shortages to influence the market and sell more of the high profit wares would be violations of antitrust laws. But those wonderful DEA quotas are a gift from the capatilist gods. And the DEA, last I checked part of the Justice Dept., says they have no control over how APIs are used, what's produced. Even the Joe Fridays here can predict the future.
The point is that the shortage occurred regionally for most of 2011 and was allowed to grow. There is a duty to make these medications available for legitimate use. Some 20 years ago the DEA itself said so.
In time, we may see the epidemic of psychosis and rotted teeth of those poor kids drugged by negligent parents and their pill whore doctors and mend our ways. Until then we'll depend on the fear mongerers for the sermon.
Time for me to go drop some Dexedrine and trip out.
BTW JC, twenty years ago (1993) there was a similar shortage of methylphenidate. But then facts just muddy up the message.
The FDA first creates, or at least excerbates, the drug shortage problem by using their inspection authority to slame domestic drug plants with over zealous, GMP-based inspection observations, and then tries to act like the knight on the white horse, coming to the rescue of the public by easing the importation of like drugs from overseas competitors! How absurd. If Mr. Pallone and Mr. Waxman wanted to do something useful, try encouraging the FDA to descriminate between situations of real adulterated or misbranded product, and those situations which might lead to bad product, namely the 2nd and 3rd tier GMP violations, like not signing a batch card or missing a calibration date. The inability of the FDA to moderate their inspection criteria based on real bonafide threats to our drug supply is hurting our domestic industry, and causing drug shortages. If the agency must always regulate with indescriminantly, perhaps they can move shop, lock, stock, and barrel to China, where there are real threats of contaminated drug products!
Sparky speaks the truth. Government knows how to create shortages like no one else. Given the overwhelming incompetence of government agencies, if the FDA were put in charge of the Mojave Desert, in two years there would be a shortage of sand, and we would have to import it from the Middle East to support the 1500 species of plant life that exist there.
Correct!!!! The shortage is from pill mill doctors! I've been battling my wife over this crap for a couple years! Her last doctor got put in prison for it. He prescribed her Vicodin and whatever else she wanted with knit a phone call, and her mom, and dad, and brother. She would eat them like candy all day every day and stay running for days. A couple years ago she stopped and started on adderall after here sister who takes them to lose weight gave here the doctors number. She has a prescription that she runs out of often andif she runs out b4 refill time she tries to buy them from someone. If not, she sleeps for 12-18 hours a day til she can get her script filled. And it's only a phone call away. She pays $100 to visit the office every three months. She has never had ADHD or narcolepsy! She's an addict and I'm trying to figure out how to get the scripts or the doctor to stop! If anyone knows how I can put done pressure on the "doctor" please let me know. K.durham1969 at g mail. Com. The k u!