23536
Bluelight Crew
Medicines 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.
http://www.nytimes.com/2012/01/01/h...-attention-drugs-in-short-supply.html?_r=1&hp
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.
http://www.nytimes.com/2012/01/01/h...-attention-drugs-in-short-supply.html?_r=1&hp
