Drug Makers Get Help With Accutane SafetyNov 24, 2004 | Star Ledger
The manufacturer of the acne drug Accutane and companies producing generic versions of the medicine said yesterday they will step up efforts to reduce the risks of birth defects by borrowing from a system Celgene uses to restrict distribution of Thalomid.
The agreement comes less than a week after David Graham, a veteran scientist with the Food and Drug Administration, told a congressional committee that five drugs, including Accutane, may be too dangerous to keep on the market.
The deal allows Hoffmann-LaRoche, the maker of Accutane, and generic drug makers Barr Pharmaceuticals, Mylan Laboratories and Ranbaxy Laboratories to license the rights to Celgene's national registry for Thalomid. The companies did not disclose the financial details, but a spokesman for Celgene called the arrangements "modest."
Celgene, based in Warren Township, uses the registry to monitor physicians and pharmacists who prescribe and dispense Thalomid, Celgene's name for the notorious drug thalidomide.
Thalidomide was blamed for causing thousands of deformed babies in Europe and Canada during the 1950s and 1960s. In order to get regulatory approval to market the drug as a treatment for leprosy in 1998, Celgene was required to design a distribution system capable of preventing more birth defects.
Carolyn Glynn, a spokeswoman for Nutley-based Hoffmann-LaRoche, said the registry for Accutane, which is also known by its chemical name isotretinoin, is still being developed. In their announcement about the licensing agreement with Celgene, the companies also said they have hired Covance, of Princeton, to develop the registry.
Accutane was approved by federal regulators in 1982 to treat severe acne that did not respond to conventional treatments such as antibiotics. Under a physician's care, most patients remain on the drug for just five months.
Like Thalomid, Accutane poses a risk to pregnant women. The drug is blamed for causing 162 Accutane birth defects between 1982 and 2002, according to the March of Dimes. Nearly 2,000 pregnant women were exposed to the drug during that period.
During Accutane's 22-year history, Hoffmann-LaRoche has struggled with the drug's safety issues. The introduction of generic versions and the Internet, which creates a marketplace where consumers can obtain drugs without a prescription, have only heightened concerns over the drug's safety.
There are three generic versions of Accutane: claravis, amnesteem and sotret.
Hoffmann-LaRoche already requires female patients to get two pregnancy tests before they receive a prescription for Accutane. The registry would add another level of verification to ensure the existence of a lab-certified pregnancy test before a prescription is written.
"This is an enhancement of what we already have," Glynn said.
In 2002, Hoffmann-LaRoche created its own system to manage the risks of Accutane, and each of the generic drug makers was required to do the same. But critics have said the systems aren't working effectively to ensure that pregnant women don't receive the drug allegedly because the manufacturer was trying to avoid Accutane recall from the market and to make any patient abstain from retaining an Accutane lawyer rather than to warn patients about the drug’s side effects.
"We've always said that (Accutane) should be as restricted as Thalomid," said Michele Kling, a spokeswoman for the March of Dimes, which threatened to push for a ban on the drug. "This is a step forward."
In a statement yesterday, the FDA also said the registry should strengthen the systems already in place by Hoffmann-LaRoche and the generic drug makers.
"As stated in 2002, the goal of the agency was to eliminate fetal exposure to isotretinoin by ensuring that no woman start therapy if pregnant and no woman on isotretinoin therapy become pregnant," the FDA said in its statement. "This new program will go a long way to achieving this goal."