Why Accutane was Withdrawn: The Bloomberg Article

On June 26, 2009, Roche Holding AG pulled Accutane, the acne drug, from the U.S. market. Bloomberg reporters Jef Feeley and Sophia Pearson filed an article that day that has been cited many times and is excerpted here.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.”

The article goes on to say that Accutane went on the market in 1982, and until the patent expired (in 2002) it was taken by approximately 13 million people and netted the drug firm its second-highest sales.

The boom is over; a company representative told Bloomberg that Roche’s market share for Accutane by prescription is now below 5 percent.

Bloomberg communicated with Shelley Rosenstock, a spokeswoman for Roche’s Nutley, New Jersey-based U.S. unit, who said in an e-mailed statement that Accutane’s safety wasn’t part of the decision to yank it off the U.S. market. She said Accutane has also been withdrawn in 11 other countries, including France, Denmark, Austria, Germany, Portugal, Norway and Spain.

“Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA,” she said in the statement.

At the time the Bloomberg article was written, Roche faced as many as 5,000 personal-injury claims over Accutane.

If you have any questions or concerns about side-effects you or a loved one may have experienced with Accutane, contact Eric Gruenwald, Attorney / Lawyer at 866 529 0001, EXT. 245  or by email at help@mulliganlaw.com

Leave a Reply