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Stricter Tracking Standards
The company and three generic manufacturers will start stricter company-run tracking standards for women taking isotretinoin, including the distribution of unique identification numbers for all patients.
The numbers would be used in a single, centralized database including qualified doctors, pharmacists, and their patients. Doctors would have negative pregnancy tests confirmed and patients would be required to hear repeated educational messages before they could receive 30-day refills.
"If they don't access the system properly, they cannot get the product," Huber says.
Other groups called on the FDA to take stricter action, citing continued pregnancies while women take isotretinoin. The consumer group Public Citizen called on regulators to take the drug out of regular distribution and make it available only under very tightly regulated conditions.
The tracking programs are "clearly a failure," says Sydney M. Wolfe, director of Public Citizen's health research group. He called on regulators to stop "needless use of a drug that each year causes the need for hundreds of abortions" and birth defects.
The March of Dimes called on the FDA to mandate stricter tracking programs for the drug. The group released a statement warning that it would call for a ban on oral forms of isotretinoin if the FDA does not mandate stricter tracking standards for women.
The committee is expected to vote Friday on whether to back the new program or recommend that the FDA take stricter action.
Peter A. Gross, MD, the chairman of the FDA's drug safety and risk management advisory committee, told WebMD that cases of pregnancy in women on isotretinoin are "a tragedy."
"You can't make people do what they ought to do," he says.
Gross notes that the drugmaker's proposal for a tighter tracking program is similar to what the committee recommended to the FDA in 2000.