F.D.A. IS FINDING ATTENTION DRUGS IN SHORT SUPPLY

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.

"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.

And, Dr. Fox said, while manufacturers sometimes use their limited
quotas to ensure adequate supplies of high-priced branded drugs at
the expense of low-profit generics, all of the issues would be
resolved if the Drug Enforcement Administration were simply more
generous with its quotas, particularly since sales of A.D.H.D.
medicines have risen so rapidly.

Doctors wrote 51.5 million prescriptions for A.D.H.D. drugs in 2010,
with a total sales value of $7.42 billion - an increase of 83 percent
from the $4.05 billion sold in 2006, according to IMS Health, a drug
information company.

Agent Boggs of the Drug Enforcement Administration said his agency
was concerned that A.D.H.D. drug abuse was on the rise. "We see
people abuse it in college and then continue to abuse it nonmedically
once they leave," he said.

Since the drugs have been shown to improve concentration, and not
just in people with A.D.H.D., they have become popular among students
who are seeking a study aid. And since they can impart a euphoria
that users have likened to a cocaine high, the pills are sometimes
ground up by people who snort them for a thrill.

On the other hand, there are people like Sheryl Greenfield of Bryn
Mawr, Pa., an A.D.H.D. patient who spent days calling dozens of
pharmacies to find a generic substitute for Adderall XR. She finally
gave up and bought the brand, and her co-pay went to $200 from $10.
"I can afford the difference, but I know some people who can't," she said.

Shortages of amphetamine-based drugs like Adderall became so endemic
that many doctors switched patients to methylphenidate-based drugs
like Ritalin, creating shortages among those medicines as well,
according to the F.D.A.

Ruth Hughes, chief executive of Children and Adults with Attention
Deficit Hyperactivity Disorder, a patient advocacy organization, said
the drug shortages had become so acute that many patients were going
untreated, increasing their risks of deadly traffic accidents and job
dismissals. "The consequences of not getting treatment can be
devastating," Ms. Hughes said.

Dr. Alexander Lerman, a psychiatrist from Chappaqua, N.Y., said his
patients could not simply switch from one medicine or dosage to
another without consequences. And some of his patients, he said,
cannot afford the branded version of the drugs.

"For the first time in my career," Dr. Lerman said, "there is this
enormous and mysterious scarcity of the basic product that is proven to work."