FDA Increases Restrictions on Acne Drug

Federal regulators on Friday unveiled a high-tech system to restrict distribution of Accutane, a drug that has been particularly effective against severe acne but has long been known to cause birth defects and is being studied for a possible connection to teen suicides.

Patients, doctors, pharmacists, wholesalers and manufacturers will be required by the Food and Drug Administration to enroll and participate in an Internet-based tracking system primarily designed to ensure that women don’t get pregnant while taking Accutane.

Women of childbearing age will be required to submit the results of monthly pregnancy tests, and all patients will have to acknowledge that they understand the potential for psychiatric side effects, which will also be emphasized in stronger warning language.

Although welcomed by some experts, the FDA’s actions are unlikely to satisfy critics who say the agency has neglected its duty as a drug safety watchdog. Accutane has been on the market for many years, and these critics say the measures the FDA has taken will not keep doctors from prescribing it to patients who may not need such strong medicine.

Accutane was one of five drugs named in the fall in congressional testimony by FDA whistle-blower Dr. David Graham as deserving a critical reexamination of their risks and benefits. In an interview Friday, Graham questioned whether the new monitoring program would work.

“It will not sufficiently reduce the use of Accutane for less severe forms of acne,” said Graham, a drug safety officer.

“A restricted distribution system should have been in place 15 years ago, and FDA scientists from both the drug safety office and the [drug] reviewing division were urging that it be adopted,” he added.

It is fairly common for regulators to restrict access to powerful drugs, and patient registries are a standard tool for closely monitoring safety, but a computerized system involving so many players is new territory for the FDA.

“This is a system long in the works, and many would say it is long overdue,” said Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs. “The responsibility that fetuses not be exposed to this medicine is enormous and is shared by everyone who participates” in distributing, prescribing or taking the drug.

About 100,000 prescriptions a month are written for Accutane or its generic equivalent, isotretinoin. Although the FDA says it should be used only to treat a disfiguring condition known as severe recalcitrant nodular acne, doctors are free to prescribe it as they judge best.

Graham said an estimated 3,000 to 4,000 women a year get pregnant while taking Accutane, and most opt to have abortions. Other drug experts said the FDA’s actions were an encouraging sign.

A more comprehensive tracking system was needed because current efforts have not been effective in keeping women from getting pregnant while using the drug, said Dr. Brian Strom, chairman of the biostatistics and epidemiology department at the University of Pennsylvania School of Medicine.

“This has been a public health dilemma,” Strom said. “It is an extraordinarily effective drug. Simply put, you take it for four months and your acne goes away for life. But it’s also extremely effective at causing birth defects. How many birth defects and how many abortions are acceptable? But the flip side is, do you deny this drug to men and women who are responsible about how they take it?”

Strom was a member of an FDA advisory committee that more than a year ago recommended much more stringent precautions for patients taking Accutane, including monthly pregnancy tests.

The FDA’s new tracking system, called iPledge, will go into effect Dec. 31. Wholesalers, pharmacies, doctors and patients will have to register with the system to sell, prescribe or take Accutane and its generic versions. Patients will be able to register on the Internet or through a toll-free number.

All patients will have to acknowledge that they have been counseled about the risks of Accutane. Women of childbearing age will have to provide two negative pregnancy tests before starting to take the drug, a negative pregnancy test every month while taking it and another negative test a month after their treatment ends. Home pregnancy tests will not be accepted.

Women must also agree to use two forms of birth control during treatment or to abstain from sex.

Doctors and pharmacists will access the iPledge system when prescribing and dispensing the drug. If a patient is not registered in the system, or if pregnancy test results are missing, pharmacists will not be able to fill a prescription.

Accutane manufacturer Roche said it strongly supported the new system.

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Top seller

The FDA introduced a system to track the distribution and use of pills containing isotretinoin, the active ingredient in Accutane and its generic competitors. Isotretinoin carries a risk of birth defects if it is taken during pregnancy.

Market share for all prescription acne drugs in 2004

Accutane: 31.6%

Amnesteem: 21.9%

Retin-A Micro cream: 12.7%

Tretinoin cream: 9.3%

Claravis: 7.6%

Other: 16.9%

(Generic isotretinoin is also sold as Sotret (not shown) and under the chemical name

Accutane)

Source: IMS Health, AP