Meet an MS sufferer confident of completing the 26 miles
May 1, 2001
By Lisa Richwine
WASHINGTON (Reuters) - U.S. regulators have warned Biogen Inc. about misleading promotions regarding the company's only marketed product, the multiple sclerosis drug Avonex.
In a warning letter made public Tuesday, the Food and Drug Administration said a Jan. 16 press release contains "representations that are false and misleading" regarding Avonex, the world's leading MS treatment with $761 million in sales last year.
Biogen spokeswoman Kathleen O'Donnell said the company removed the press release from its Web site and had resolved the FDA's concerns.
In the release, the company said a new study of Avonex met its primary objective, which was showing improvement on a scale that measures function in patients with secondary progressive MS.
The FDA said the press release "contains representations and suggestions that are false and misleading" and violate federal rules requiring drug promotions to be accurate and balanced.
The statements "represent continuing examples of violative promotion or advertising materials disseminated by Biogen," said the letter from Steven Masiello, director of the FDA's office of compliance and biologics quality.
Earlier FDA letters charged Biogen with violating federal advertising rules with statements about unapproved uses and other "misleading" Avonex claims in two brochures, two journal ads, a sales sheet, a letter to doctors and two other press releases.
The latest letter was sent March 29 and released by the FDA's Freedom of Information Office on Tuesday.
O'Donnell said the company had pulled materials that drew FDA objections and clarified some statements in question.
"Everything that they have raised was handled. We clarified and did what they have asked," O'Donnell said.
The FDA sends hundreds of warning letters a year. Most are resolved without further action.
In the letter to Biogen, the FDA objected to statements in the Jan. 16 release that said a new study of Avonex met its primary objective of showing improvement on a scale that measures function in patients with secondary progressive MS. Avonex is not approved to treat that type of MS.
The FDA said it had told Biogen that the scale used to measure improvement "had not been validated" and that data from the trial "would not be adequate to support the efficacy of Avonex in secondary multiple sclerosis."
Avonex is approved for treating relapsing forms of MS but not the secondary progressive type of the disease.
O'Donnell said the measurement used in the trial "is where the cutting edge is right now" and that "science and medical advances can sometimes be ahead of regulatory understanding."
"We are continuing to talk with the FDA" about the measurement, O'Donnell said.
Biogen, whose Avonex was approved by the FDA in May 1996, is focused primarily
on developing and testing products for the treatment of multiple sclerosis,
inflammatory and respiratory diseases, kidney diseases and certain viruses
1999 Reuters Limited.