February 10, 2006

Acne drug limits burdensome, doctors say

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) - A plan to prevent birth
defects from a widely used acne drug is placing heavy burdens
on doctors, patients and pharmacists and should be halted until
flaws can be fixed, doctors said on Friday.

The restrictions on Roche AG's Accutane or generic versions
are so cumbersome and time-consuming they may send patients to
the Internet, where medicines may be counterfeit and there are
no safeguards to prevent pregnancy, critics said.

Accutane is the only drug approved for severe scarring acne
that does not respond to other therapies. The drug can cause
serious birth defects or miscarriages, and several attempts
have been made since its 1982 approval to prevent pregnancies
among women taking the drug.

More than 1,000 women have become pregnant while using
Accutane, according to the March of Dimes, a group that works
to prevent birth defects.

Stricter measures on sales of the drug take full effect
March 1, but some dermatologists started complying with them at
the end of last year during a transition phase.

"The results today are a disaster. Pharmacists, prescribers
and patients are confused and frustrated," Dr. Diane Thiboutot
of the American Academy of Dermatology Association told a U.S.
Food and Drug Administration advisory panel.

The dermatologists group requested a delay of two months
before the new program takes full effect.

Under the plan, patients, doctors, pharmacists and
wholesalers must register with drug makers and take other
steps. Women of child-bearing potential must sign consent forms
and have monthly pregnancy tests. Doctors must tell patients
about risks.

A computer system that verifies the safety steps have been
followed is hard to access via the Internet or phone, Thiboutot
said. Passwords are sent by mail, often too late to get a
prescription filled. Some patients must make repeat visits to a
doctor. Anyone seeking help by phone faces waits of up to
several hours, she said.

"No one is compensating us for this ... it is taking time
from other patients," Thiboutot said.

Covance Inc., the company that runs the pregnancy
prevention program, is trying to make the system easier to use,
said James Shamp, a Covance director.

"We have heard those concerns and we are committed to
working with the (dermatologists) to resolve those issues," he

The FDA also is working with companies to fix problems but
may delay the start date, said Dr. Sandra Kweder, deputy
director of the FDA Office of New Drugs.

Accutane also is known by the generic name isotretinoin.
Mylan Laboratories Inc., India's Ranbaxy Laboratories Ltd. and
Barr Pharmaceuticals Inc. sell generic versions. More than 1
million prescriptions per year are written for the medicine.

Dr. Peter Gross, the advisory panel chairman, said he had
no sympathy for doctors' complaints about the length of the

"We are concerned about patient safety. If it takes a
little more time -- tough," said Gross, head of internal
medicine at Hackensack University Medical Center in New Jersey.