Oct. 8, 2004 -- A bipartisan group of lawmakers are accusing the Bush administration of moving too slowly on proposed new safety measures for the acne drug Accutane and are calling for the drug to be pulled from the U.S. market.
The lawmakers say the FDA has not acted on February recommendations from an expert advisory panel urging the agency to implement stricter patient tracking rules for patients who use Accutane. Several are threatening to insert legislation restricting Accutane's use into a federal spending bill if action is not taken by Nov. 1.
Accutane has been the subject of public scrutiny in recent years because of several health concerns, including an increased risk of birth defects in children born to women who take it while pregnant and a possible risk of depression and suicide in adolescents.
An expert panel urged the FDA in February to come up with stricter rules for tracking women of childbearing age in an effort to prevent them from becoming pregnant while taking Accutane. Experts recommended at that time the use of a mandatory patient registry and required patient education for everyone who uses Accutane for severe acne. But the agency has so far failed to act on the recommendations.
"There shouldn't be a lag time when you're talking about life and death of young people," says Rep. Bart Stupak (D-Mich.). "It's a very serious health issue, and we wish they'd treat it that way."
Stupak and three Republican lawmakers sent a letter earlier this week to Health and Human Services Secretary Tommy G. Thompson criticizing the FDA for moving slowly on new Accutane rules and urging the agency to pull the drug off the market until action is taken.
The letter points to a small study conducted at Emory University in Atlanta showing that Accutane can affect brain metabolism. Stupak, who's 17-year-old son committed suicide four years ago while taking Accutane, says the study is evidence that the drug has potential to play a role in depression or suicide.
"We all realize that more research is needed; but we cannot allow this drug to continue on the market, prescribed at a rate of 1.8 million prescriptions annually, when it may affect the brain of young people," the letter states.
The letter also threatens to push legislation in Congress that would restrict widespread "off-label" use of Accutane and require a mandatory patient registry for everyone taking it. The bill has 14 Republican and Democrat co-sponsors. Off-label use describes use for purposes other than those approved by the FDA.
Accutane prescribers must now obtain an informed consent from patients, offer counseling, and provide educational materials.
Women are supposed to have two negative pregnancy tests before receiving a prescription for Accutane, and women are supposed to use two forms of contraception during therapy.
But Accutane maker Hoffmann-La Roche Inc. reported to the FDA that 183 women took Accutane while pregnant during its strict tracking program in 2003, compared with 150 in the year before. Three manufacturers of the generic version of Accutane, called isotretinoin, reported 19 more cases since December 2002 while using identical tracking programs.
Stupak tells WebMD that the FDA has given him information also connecting Accutane to suicide in 235 young people. The agency could not confirm the figure.
An 'Active Situation'
Lester B. Crawford, the acting FDA commissioner, declined to comment when asked about Accutane. His office later issued a statement saying that the agency "is continuing to work on the recommendations made by the Advisory Committee" in February.
Bill Pierce, an HHS spokesman, says that the agency is "in an active situation" trying to finalize a patient tracking system and risk-management program for Accutane.
Officials familiar with the issue say the FDA is moving slowly because of a dispute between four manufacturers of isotretoin and Celgene, a company that makes the drug thalidomide.
Thalidomide is infamous for causing thousands of birth defects in the 1960s, and the company holds patents on a patient registry program widely credited with cutting rates of pregnancy exposures to the drug.
Isotretoin makers want to use the Celgene program, though companies have not reached agreement on licensing the product.
"It's another hurdle that has to be overcome," says Carolyn Glynn, a Roche spokeswoman. The company sold approximately $85 million in Accutane prescriptions in 2003, about one-quarter of the isotretinoin market, she says.
Asked about the lawmakers' Nov. 1 threat of legislation to restrict Accutane's use, Glynn said, "I can't react to deadlines."
Brian Gill, a Celgene spokesman, tells WebMD his company has offered isotretinoin makers "commercially reasonable terms" for the licensing of the patient tracking program and that the company "continues to be open to negotiations."