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 said.
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 process.
“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.
Revision date: June 11, 2011
Last revised: by Sebastian Scheller, MD, ScD