LOS ANGELES, June 11 /PRNewswire/ --
AIDS Healthcare Foundation (AHF) -- which recently sued drug maker
Abbott Laboratories for publishing false statements deceiving the
public about a 400 percent price hike to its AIDS drug Norvir --
released the following statement today regarding a US Food and Drug
Administration (FDA) "warning letter" to Abbott that demands
an end to its misleading price claims about Norvir:
"We are very gratified that
federal regulators finally acted to stop the lies, half-truths and
distortions by Abbott about the Norvir price increase," said AHF
President Michael Weinstein.
"Paper will take anything that
is written on it, but the FDA will not," said Weinstein. "We
believe this begins a long series of legal sanctions against Abbott
for deceptive business practices concerning Norvir."
According to the FDA letter to
Abbott, the drug maker's ad about Norvir pricing is "false and
misleading." The FDA states that Abbott's published cost chart
"raises significant public health and safety concerns because of
the violations outlined above and the potential adverse impact these
false and misleading messages may have on the HIV community by
promoting a sub-therapeutic dose and regimen of Norvir," (source:
www.fda.gov -- search word "Norvir").
The letter directs Abbott to respond by June 25 "explaining your
plan for discontinuing use of such materials. Because the violations
described above are serious, we request, further, that your submission
include a plan of action to disseminate truthful, non-misleading, and
complete information to the audience(s) that received the violative
promotional materials."
In March of the year, AHF filed a
false advertising lawsuit against the Chicago-based pharmaceutical
over claims that Abbott makes concerning its AIDS drug prices and
policies -- charges echoed in the FDA letter. AHF's action in Los
Angeles County Superior Court [case# BC312305], under California
Business and Professions Code Section 17200, et seq., and other
applicable state law, challenges Abbott's claims regarding its Norvir
price hike and the impact this price increase will have upon
overburdened and under-funded state Medicaid programs such as Medi-Cal.
The complaint alleges, "Abbott's assertions that state Medicaid
programs would be unaffected by the increase were fraudulent, false
and/or misleading and constituted unfair business practices that
induced consumers -- including AHF -- to continue buying its products,
despite its contemptible conduct."
In February, AHF also filed a
federal anti-trust and restraint of trade lawsuit against Abbott
concerning its drug prices and policies for Norvir and its subsequent
derivative drug, Kaletra. That suit is currently pending.
"The federal anti-trust
complaint responds to Abbott's initial, egregious and unprecedented
400% price hike on Norvir back in December," said Weinstein.
"The false advertising lawsuit deals with the 'cover up' -- the
fact that Abbott is engaging in deceptive business practices, false
advertising and fraud by misrepresenting the impact of the increase.
The FDA letter also states that Abbott's claims are false and must be
suspended immediately."
The price move by Abbott has created
a continued uproar and outcry among AIDS advocates nationwide. While
Abbott claims that there is no price increase for AIDS Drug Assistance
Programs (ADAP) or for state Medicaid plans. Activists and physicians
have called for a price rollback, attorneys general of California,
Illinois and New York are investigating, and an
"un-invitation" is being prepared for Abbott from activists
attending next month's International AIDS Conference in Bangkok.