Caught in between are millions of children and adults who rely on the pills to help them stay focused and calm. Shortages, particularly of cheaper generics, have become so endemic that some patients say they worry almost constantly about availability.
While the FDA monitors the safety and supply of the drugs, which are sold both as generics and under brand names like Ritalin and Adderall, the DEA sets manufacturing quotas that are designed to control supplies and thwart abuse. Every year, the DEA 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 ADHD medicines - preparing some as high-priced brands and others as cheaper generics - is left up to the company.
Now, multiple manufacturers have said their medicines are in short supply. The FDA has included these pills on its official shortages list, as has the American Society of Health-System Pharmacists. And the American Academy of Child and Adolescent Psychiatry has told its members that shortages seem to be “widespread across a number of states’’ and are “devastating’’ for children.
Officials at the FDA say the shortages are a result of overly strict quotas set by the DEA, 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.
The situation has made for a rare open disagreement between two federal agencies.
“We have reached out to the DEA and told them that there are shortage issues,’’ said Valerie Jensen, associate director of the FDA’s drug shortage program. “But the quota issues are outside of our area of responsibility.’’
Still, Special Agent Gary Boggs of the DEA’s Office of Diversion Control, said in an interview, “We believe there is plenty of supply.’’
