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Feb. 28, 2006 -- A new safety program designed to prevent fetal exposure to the acne drug isotretinoin (Accutane) is due to start Wednesday, despite critics who say the program won't work.
The program is the latest of several attempts over recent years to prevent women from taking the drug while pregnant or from becoming pregnant during treatment.
The FDA is pushing ahead with plans to launch the program, known as iPledge, on March 1, despite protests from dermatologists complaining that it is overly burdensome and won't succeed in preventing exposures.
The drug has been sold in the U.S. since 1982 and is intended for patients with severe, scarring acne that does not respond to other treatments.
Isotretinoin has been shown effective against severe acne. But the drug can also cause severe birth defects, mental retardation, premature birth, and spontaneous abortions in the fetuses of women who take it while pregnant.
Tighter Restrictions
The program will require all patients taking the drug to register online before receiving a prescription. Doctors must counsel women of childbearing age about the importance of not becoming pregnant while on the drug and women will have to sign a consent form acknowledging the drug's risks. Also, negative pregnancy tests will be needed before starting the drug, every month before receiving a refill prescription, right after the last medication dose, and one month after that last dose.
Women of childbearing age also must have two negative pregnancy tests and commit to using two simultaneous forms of contraception before being given a starting prescription. Doctors, pharmacies, and drug wholesalers must also register with iPledge to be eligible to prescribe and distribute isotretinoin.
"It's a comprehensive program involving all the parties," says Susan Cruzan, an FDA spokeswoman.
The agency said in a statement last week that it had worked with drug makers and others "to maintain a critical balance between access to the drug by patients who need it and ensuring its safe use."
Doctors Protest
But physician groups asked the FDA to delay the launch of the program because of complaints of long waits on a call-in line and a rule requiring women to receive pregnancy test results no more than a week after meeting with a doctor.
"It puts too much bureaucracy between patients and physicians," Clay Cockerell, MD, president of the American Academy of Dermatology, tells WebMD.
An estimated 30,000 physicians have already signed on with the registry to be eligible to prescribe isotretinoin. Less than 30,000 patients are estimated to have signed up with iPledge, which is being run by Covance, Inc., a drug services company.
But Cockerell says dermatologists are already keenly aware of isotretinoin's risks and that the program won't prevent patients from finding the drug on the Internet.
"The bottom line is, we just don't think it's going to work," he says.
Accutane is sold by Swiss company Hoffmann-La Roche Inc. Three other firms sell the drug in generic forms. Roche reported to the FDA in 2004 that 183 women took the drug while pregnant during its earlier tracking program, compared with 150 in the year before. Generic manufacturers reported 19 more cases since December 2002 while using identical tracking programs.
Covance spokeswoman Laurene Isip said in an emailed statement that the company believes iPledge will be effective and simpler than earlier safety programs. "The program strives to ensure that no woman starts therapy if she is pregnant and that no woman taking isotretinoin becomes pregnant during treatment for one month afterward," the email stated.
Unsuccessful Programs
An earlier restriction program, known as SMART, largely failed to prevent pregnant women from taking isotretinoin.
Rep. Bart Stupak (D-Mich.), a sharp critic of the drug, criticized the iPledge in an interview as being too lax. The program only requires the registration of pharmacies, not individual pharmacists, and carries no penalties for prescribers who don't comply, he says. The program should also track psychiatric side effects, which some reports have linked to depression and suicide in users, Stupak says.
"It's better than what we had, but it's nowhere close to good enough," says Stupak, whose 17-year-old son committed suicide while taking Accutane in 2000.
"There are no consequences, so it's just going to be ignored," he says.
Isip says that the company was developing plans to track the program's effectiveness.
You can contact the iPledge call center 1-866-495-0654 Monday-Saturday 9 a.m. - midnight EST and through the web site at www.ipledgeprogram.com.
SOURCES: Susan Cruzan, spokesperson, FDA. iPledge web site, . Clay Cockerel, MD, president, American Academy of Dermatology. Hoffman-LaRoche Inc. Rep. Bart Stupak (D-Mich.). Laurene Isip, spokeswoman, Covance.