FDA And Roche Were Criticized By The Congress. The Food and Drug Administration and a New Jersey drug maker were sharply criticized by members of Congress yesterday for failing to tightly regulate use of the acne drug Accutane.
The medicine, produced by Nutley drug maker Hoffmann-La Roche, is known to cause birth defects and has been blamed for teenage suicides.
“The FDA’s response to the Accutane birth defects and psychiatric events has been inadequate, irresponsible and unacceptable,” Rep. Bart Stupak (D-Mich.) said during a hearing before the House Energy and Commerce subcommittee. “The drug manufacturer, Hoffmann-La Roche, has continued to put profits before people.”
Stupak, who blames Accutane for his 17-year-old son’s suicide in 2000, has led the fight against the hugely popular drug, prescribed to an average of 600,000 people each year.
Roche President and Chief Executive George Abercrombie told the congressional panel fewer prescriptions and sagging sales are evidence they are actively informing their patients of Accutane’s risks.
“We have acted in a responsible manner by adopting precautionary measures to communicate psychiatric information to prescribers and patients,” Abercrombie testified.
misuse of the powerful medication
But Stupak was joined by other lawmakers expressing concern about misuse of the powerful medication.
“This drug is perhaps more dangerous to pregnant women than Thalidomide, yet women are still getting pregnant while taking it,” said Rep. Peter Deutsh (D-Fla.), comparing Accutane to the notorious 1960s morning sickness pill that caused birth defects. “It’s a tragedy.”
Stupak claimed Accutane was the cause of more than 200 teen suicides a figure disputed by Roche and at least 172 birth defects.
Along with Deutsh and other lawmakers, he called for new controls, including creation of a mandatory FDA registry that would require every patient taking Accutane and every doctor prescribing it to enter a national database so the side effects could be monitored.
Currently, participation in a pregnancy prevention and monitoring program for Accutane is voluntary. The program includes two pregnancy tests, a commitment to use contraception while on the drug, a signed letter of consent and follow-up surveys to monitor side effects. Only 43 percent of female users are fully participating in the program.
FDA officials defended their regulation of Accutane, arguing that clear warnings of possible birth defects and psychological side effects appear prominently on the front of Accutane packaging.
They also pointed out that scientific studies have yet to link Accutane to depression, suicidal thoughts or suicide.
“All the evidence (on suicides) is anecdotal,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “There is no scientific link to take this drug off the market.”
Abercrombie, the Roche CEO, said his company has curtailed its aggressive advertising campaign for the drug and distributed an extensive battery of literature for both patients and physicians.
He added that Accutane is one of the few medications for any disease that requires signed consent by the patient before being prescribed.
Accutane, the brand name for isotretinonin, is the only proven treatment for very severe cases of acne, prompting many dermatologists to enthusiastically recommend it despite its side effects.
Since its inception in 1982, the drug has treated more than 13 million people and last year earned $750 million for Roche, making it one of the drug maker’s top products.
During the hearing, the subcommittee also heard from patients who benefited from Accutane and from Cornell dermatologist Diane Berson, who called it a “life-changing” medicine.
“Accutane is an extremely valuable drug which I feel must remain available for dermatologists to prescribe to those patients who clearly need it,” Berson said.
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