The FDA is up to no good again and we could see some severe volatility in CELG. Has the FDA heard of the First Amendment. The evidence of Thalidomide's effectiveness in Multiple Myeloma is nothing short of compelling. We are talking about deadly diseases. No one is pushing the drug to pregnant woman. I thought the Bloomberg article is well balanced
Celgene Promoted Thalidomide Drug for Unapproved Uses, FDA Says
By Brian Reid
Washington, April 21 (Bloomberg) -- Celgene Corp. promoted
unapproved uses of its thalidomide drug to doctors, the U.S. Food
and Drug Administration said in a warning letter.
Thalidomide, which is sold by Celgene as Thalomid, was linked
to severe birth defects in the 1950s and 1960s. The drug was first
approved by the FDA in 1998 for a rare complication of leprosy.
Use of the drug is severely restricted and close monitoring of
patients is required.
The FDA said the threat of birth defects arising from
improper administration of the drug to pregnant women requires
extra vigilance.
``Perhaps more than any other available drug, the need to
provide and distribute thalidomide responsibly is essential to
public health,' the agency said in the warning letter, which was
faxed to the company today.
The company's offices were closed and phone calls seeking
comment were not returned.
The FDA said that in several cases, Celgene sales
representatives asked doctors to consider using the drug to treat
cancer. Though studies of the drug, including one published last
November in the New England Journal of Medicine, have shown the
drug appeared effective in treating a deadly form of blood cancer
called multiple myeloma, the agency hasn't approved that use of
the drug. Doctors may decide to use the drug to treat the cancer
but sales representatives are not allowed to promote that use.
Celgene marketing has drawn FDA criticism before: The FDA
raised concerns that the company was illegally promoting the drug
in late 1998 and said that it considered the recent problems to be
evidence of ``a continuing pattern and practice of violative
behavior.'
The agency asked the company to stop all improper promotion
of the drug and forward a copy of the warning letter to all sales
representatives. The agency also asked the company to develop a
plan to avoid similar violations in the future.
Off-label promotion has been important to the growth of
Celgene's sales of Thalomid, analysts said. The company estimates
that only about 1,000 people in the U.S. have the leprosy
complication the drug is approved to treat, while about 40,000
patients have multiple myeloma.
The FDA sends hundreds of warning letters to companies each
year; only a small number result in significant agency action.
Still, the letters can be the last notice before the FDA takes
steps such as holding up shipments of a product or pursuing civil
fines. |
