edicines to treat
attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the
Food and Drug Administration that they are unable to find a pharmacy with enough pills to fill their
prescriptions. The shortages are a result of a troubled partnership between drug manufacturers and the
Drug Enforcement Administration, with companies trying to maximize their profits and drug enforcement agents trying to minimize abuse by people, many of them college students, who use the medications to get high or to stay up all night.
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 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.
The situation has made for a rare open disagreement between two federal agencies.
“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.”
Some high-priced pills are indeed readily available, and D.E.A. officials said that so long as that is the case, they believe that A.D.H.D. drug supplies are adequate. Agent Boggs attributed any supply disruptions to decisions made by manufacturers.
Novartis, for instance, makes both branded and generic versions of Ritalin; Shire Pharmaceuticals does the same for Adderall XR. In both cases, the companies have ensured that supplies of branded drugs are adequate while allowing generic versions to go wanting.
“We are working diligently to ensure our supply of these products meets demand, including discussions with D.E.A. regarding our quota levels for these controlled substances,” said Kathy Bloomgarden, a spokeswoman for Novartis.
But those who rely on the drugs can react very differently to apparently similar medicines, so an adequate supply of one drug does them no good when their preferred medicine is unavailable, patients and their doctors say. And prices can vary so much that some patients say they cannot afford to switch.
Lynn Whitton of Westport, Conn., who has an attention deficit hyperactivity disorder, expressed disbelief when told that the Drug Enforcement Administration said there were no shortages of A.D.H.D. medicines. “What?” she said. “I’m just flabbergasted!”
Ms. Whitton said she had recently gone to more than a dozen pharmacies in Westport and New York City before finding one that would partially fill Ritalin prescriptions for her and her 18-year-old son, who also has the disorder.
Erin Fox, manager of the drug information service at the University of Utah, said problems arise when there is a mismatch between what manufacturers choose to make and what patients are prescribed.
**Source: "THE NEW YORK TIMES"
