EU's Drug Committee Recommends Pfizer's Viagra Be Sold In Europe
June 01, 1998 12:09 AM
By Andrea Petersen, Staff Reporter of The Wall Street
Journal
Viagra is going trans-Atlantic. The European Union's
drug evaluation body recommended Friday that Pfizer
Inc.'s impotence drug be made available in the
15-country region.
The Committee for Proprietary Medicinal Products,
which is a part of the European Agency for the
Evaluation of Medicinal Products, adopted a "positive
opinion" on Viagra. The final decision on whether Pfizer
will be able to market Viagra in European Union
countries is up to the European Commission, which will
consult with all member states. But approval is all but
assured since the European Commission almost always
follows the recommendations of the committee. But
while Pfizer would be able to market Viagra as soon as
that decision is made, which could happen in about three
months, it could take months more for each country to
decide how much Viagra will be reimbursed by its
national health service.
Currently, Viagra is only available from Pfizer in the
U.S., the company said. Viagra has also been approved
in Brazil, Mexico, Morocco, South Africa and
Colombia. "We would think that by this time next year
we should have approvals pretty much world-wide,"
says Pfizer spokesman Andrew McCormick. The
company plans to begin shipping pills to Brazil and
Morocco next week. Black-market sales of Viagra have
also been reported in some countries where, it would
appear, drugs bought in the U.S. are fetching high
prices. Viagra sells at retail in the U.S. at about $8 to
$12 a pill, but there are reports that some black
marketers are getting 10 times that amount overseas.
In the wake of the six deaths Pfizer reported to the
Food and Drug Administration last week among patients
taking the drug, several countries are reportedly
considering a ban on Viagra until safety concerns are
clarified. Pfizer said such crackdowns on Viagra are
misguided. "There's a tremendous amount of speculation
and misinformation about Viagra floating around the
world," Mr. McCormick said. "As we discuss the merits
of Viagra, we will gain approval."
In a separate development, Pfizer said it is likely to begin
studies of the interaction between Viagra and protease
inhibitors used to treat HIV infection. Many doctors
who treat AIDS patients are concerned that since
protease inhibitors and Viagra are processed by the
same enzyme system, the levels of either drug might rise
high enough to cause toxicity. "My fear is that Viagra
levels will be increased," says Howard Grossman, an
AIDS specialist in New York. "But we don't know the
interaction with protease inhibitors so patients need to
be aware that we're operating in the dark here." Pfizer
said it still does not know when a study with Viagra and
protease inhibitors would begin or how many subjects
would be involved.
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