It appears Teva had submitted their data to the FDA regarding Copaxone's effectiveness and the FDA thought their data was pretty unconvincing. Teva apparently decided to just push their claims to the medical community anyway. Well, the FDA apparently just slapped them pretty hard. The following story appeared at NewsEdge in their Heathcare section:
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Teva Marion Copaxone promo corrective
campaign to include "Dear Doctor" letters
sent by mail, printed in ads in journals in
which original ads ran, FDA warning
letter says.
September 2, 1998
Health News Daily via NewsEdge
Corporation : TEVA MARION "DEAR
DOCTOR " LETTER WILL CORRECT
COPAXONE PROMOS following
receipt of a warning letter Aug. 27. In the
letter, FDA requests that Teva Marion
Partners' corrective campaign include
"mailing and publication of a 'Dear
Healthcare Professional' letter to
disseminate corrective messages...to
all healthcare providers, institutions, and
organizations who have received the
violative message."
After DDMAC approves the "Dear
Doctor" letter, it "should be
disseminated by both direct mail and
through a paid advertisement in all
journals that contained advertisements
for Copaxone during the 12 months
prior to the date of this letter," FDA
says.
FDA's Division of Drug Marketing,
Advertising & Communications claims
in the letter that the Copaxone materials
promote the multiple sclerosis therapy
for unapproved uses. Noting that
Copaxone is approved for reduction of
the frequency of relapses in patients
with relapsing-remitting MS, FDA says
the materials contain "misleading
claims that Copaxone is safe and
effective in slowing, preventing, or
reversing the long term neurological
deterioration or disability that is
associated with the progression of MS."
"To support these disability claims in its
promotional materials, TMP presents
data from a multicenter study that it
previously submitted to the agency
during the application review process,"
FDA notes. "At that time, the agency
determined that these data were
inadequate to support such claims."
The materials also suggest that
physicians using other therapies for MS
" should switch to Copaxone because it
is safer, more tolerable, or more
effective," DDMAC says. The claims
are false or misleading without
adequate and well-controlled trials
demonstrating the claimed superiority or
comparability, FDA warns. The
company's claims "state or suggest that
more than half of the patients on other
therapies discontinued those treatments
within a year, and TMP suggests that
the reason for such discontinuation was
because of safety or effectiveness."
FDA cites a brochure entitled "Why are
neurologists switching their MS patients
to Copaxone?" in which the company
"claimed that 56% of Avonex patients
and 69% of Betaseron patients quit
therapy within a year, but that there were
high levels of compliance with
Copaxone."
"TMP's claims are based on data from
a retail pharmacy database that
measured nothing more than the fact
that a prescription had been originally
filled at a retail pharmacy and whether
or not that prescription had been
refilled," FDA maintains. "Data
describing whether or not patients
refilled prescriptions at a particular retail
pharmacy are clearly inadequate to
substantiate claims that patients actually
continued or discontinued therapy."
Promotional materials for Copaxone
(glatiramer) injection referred to by FDA
include a journal ad, brochures and
booklets, a slide kit, a letter, press
releases, Internet web pages, and
leaflets. Materials also include posters
and advertising messages presented by
TMP sales reps at the American
Academy of Neurology 50th Annual
meeting.
TMP said it already has had
discussions with FDA regarding the
warning letter and that it will take the
steps outlined by FDA in the letter,
which includes the "Dear Doctor" letter
and cessation of dissemination of all
materials discussed in the letter. The
company must submit a list of all
materials it will discontinue and a list of
all materials it intends to continue
disseminating.
[Copyright 1998, Health News Daily] |
