[Pharm-policy] Public Citizen's News Release on New Schering-Plough/Claritin

[James Love]

Subject: Public Citizen's News Release on New Schering-Plough/Claritin
Report
   Date: Thu, 31 Aug 2000 15:44:49 -0400
   From:  "Diane Williams" <DWILLIAMS@citizen.org>

We thought you might be interested in the following:

For Immediate Release:
August 31, 2000
                                  Contact: Bob Young, 202-454- 5139
                                   Booth Gunter, 202-588-7703

Schering-Plough Political Money Pushes Claritin Patent Extension and
Distorts GAO Report

FDA was justified in delaying approval for Claritin

WASHINGTON, D.C. * The pharmaceutical company Schering-Plough has spent
$19.9 million on lobbying and campaign contributions since the start of
the 1996 election cycle * including more than $500,000 in soft money for
the upcoming elections * while trying to persuade Congress to extend its
monopoly on the allergy drug Claritin, according to a Public Citizen
report released today.

The report details lobbying expenditures and key campaign contributions
by Schering-Plough in its effort to win a three-year patent extension
that would cost consumers $7.3 billion over 10 years. It also analyzes
the findings of a recent General Accounting Office (GAO) study on the
federal approval process for Claritin, the blockbuster drug that
generated $2.3 billion in U.S. sales last year.

Earlier this summer, the extension legislation was attached anonymously
as a rider to the military construction appropriations bill but was
removed after it was exposed in the media.

"This company has spent millions to persuade Congress to give it a
special deal that would allow it to gouge consumers," said Public
Citizen President Joan Claybrook. "Its lobbyists couldn't get the bill
through the normal legislative process, so they resorted to a sneak
attack in the appropriations process. Now, they are distorting the
findings of the GAO to justify this corporate welfare bill."

Since the Aug. 10 release of the GAO report, Schering-Plough and its
lobbyists have claimed the GAO report supports their contention the
patent should be extended because unnecessary delays and inefficiencies
at the Food and Drug Administration (FDA) slowed the agency's approval
of Claritin.  

The facts, as laid out in the GAO report, tell a different story. It
concludes that FDA approval for Claritin took 77 months (as opposed to
the 42.5-month average for other similarly classified "pipeline" drugs)
because the agency was concerned about the cancer-causing potential of
Claritin and because Schering-Plough submitted inadequate studies about
the tablet form of the drug. 

Public Citizen's major findings include: 

· Schering-Plough spent $9.2 million on lobbying in 1999 * more than any
other drug company and twice what the company spent in 1998.  Overall,
since the beginning of 1996, Schering-Plough has spent $18.2 million to
lobby Congress and the administration.

· In the past three election cycles, Schering-Plough has contributed
$1.2 million in soft money to Democratic and Republican party
committees. In the 2000 cycle, the company's soft money contributions
total $528,500 (through July) * third highest among drug companies and
five times what the company gave in the entire 1994 election cycle. 

· Schering-Plough has dramatically increased its contributions to
Democrats in its effort to win a Claritin patent extension. In the 1996
cycle, Schering-Plough gave just 4 percent of its soft money to
Democratic Party committees. That figure has jumped to 19 percent in the
1999-2000 cycle. The same trend applies to "hard" money contributions
from the company. In the 1996 cycle, contributions from
Schering-Plough's corporate PAC favored Republicans over Democrats by a
4-to-1 ratio. In 2000, the ratio has been 1.6-to-1.

The Public Citizen report also includes analysis based on the GAO's
findings: 

· Despite Schering-Plough's claims, the GAO concluded that an FDA
reorganization did not delay Claritin approval. Specifically, "we have
no evidence that the reorganization affected the approval of Claritin,"
the report says.
 
· Contrary to the claims of Schering-Plough's lobbyists, the GAO report
never says the FDA took too long to approve Claritin. Instead, the
report says, "The major issue that delayed the approval of Claritin was
the potential significance of animal carcinogenicity data for humans.
The studies Schering-Plough submitted in the New Drug Application (NDA)
for Claritin showed evidence of increased tumors in male mice and female
rats."

· Schering-Plough submitted 37 major amendments to the FDA during
Claritin's NDA. Of these amendments, 18 dealt with carcinogenic studies
or establishing the equivalence of Claritin capsules and tablets. In
contrast, 97 percent of the NDAs submitted between 1987 and 1992
required 10 or fewer amendments.

· Claritin approval also was slowed because Schering-Plough conducted
clinical tests with a capsule form of Claritin rather than the tablet
the company intended to market. The data submitted to the FDA by
Schering-Plough "did not support that [capsules and tablets] were
equivalent," according to the GAO. 

The full text of Public Citizen's new report is available at
www.citizen.org/congress/drugs/factshts/patentextension/3splobby083000.htm 

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Public Citizen is a national consumer advocacy organization founded by
Ralph Nader. For more information about this and other Public Citizen
issues, please visit our Web site at www.citizen.org