Washington Editor

WASHINGTON - A Biogen Inc. spokesman said the Cambridge, Mass.-based company is working with the FDA to resolve possible problems in its Avonex advertising that prompted the agency to issue a letter scolding the company.

But spokesman Tim Hunt cautioned that the letter does not seek corrective action. "This is not a warning or corrective letter, it's an untitled letter.' The FDA is not requiring us to proactively contact people or write a Dear Doctor' letter. I think the letter speaks for itself and we are in discussions with the FDA about our next steps."

Dated Oct. 24, the letter cites "violative advertising and promotional labeling" related to Avonex (interferon beta 1-a), a multiple sclerosis treatment.

Hunt told BioWorld Today that the FDA raised issues related to Avonex following "routine monitoring and surveillance" of promotional materials associated with the drug. Biogen received a similar "untitled" letter for Avonex May 9.

In the most recent letter, the FDA says Biogen's headline, "Avonex delivers the highest rate of satisfaction - 95 percent among patients," and an accompanying bar graph representing patient satisfaction in brochures and on a flipchart are misleading because they represent results of a survey.

The agency also cited the claim that "cognitive dysfunction is significantly correlated with brain atrophy," saying Biogen's clinical trials did not assess such a correlation. And, Biogen's trials do not support a specific claim that the most common side effects "tend to diminish with continued use over time," according to the letter.

In another area, Biogen was criticized for its failure to place the headline, "Prescribe Therapy That is Strong Over the Long Term," near the qualifier, "as proven in the two-year Phase III trial."

The letter dated May 9 cited violative statements, including Biogen's claim that Avonex is more effective than a competing product, Rebif, in the "long term," and its characterization that Rebif offers a "short-term advantage."

According to the FDA, "Such statements are false, misleading and/or lacking in fair balance."

Serono SA, of Geneva, received marketing approval for Rebif, also an interferon beta 1-a, in March. The approval was significant because at the time, Avonex was enjoying market exclusivity as an orphan product. On winning approval, Tom Lang, president of Serono's U.S.-based operation in Rockland, Mass., said the FDA essentially decided that Rebif is superior to Avonex. (See BioWorld Today, March 11, 2002.)

Carolyn Castel, a spokeswoman for Serono, said of the FDA letter specifically naming Rebif, "We were certainly pleased with the action the FDA took because it set the record straight and it will go a long way in ensuring that patients and clinicians are not confused or misled."

As in the case of the May 9 letter, Biogen has 10 days to respond to the FDA's complaints.

BIO Supports Oversight For Crop Biotechnology

The Washington-based Biotechnology Industry Organization (BIO) adopted a voluntary moratorium to limit the geographic growing area where plant-made pharmaceuticals and industrial crops should be grown.

Specifically, a prepared statement released by BIO said its members have pledged not to grow corn not intended for food or feed use in the "heartland," also known as Illinois, Indiana, Iowa and portions of Minnesota, South Dakota, Nebraska, Missouri, Kentucky and Ohio.

The voluntary moratorium follows suggestions by the FDA and USDA that pharmaceutical-product plants that out-cross should be grown only in regions of the country where little or none of the plant's food/feed counterparts is grown. (Corn is the subject of the moratorium because it out-crosses, meaning its pollen is spread by insects or wind.)