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.