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

NOTE: IN MARCH 2001, PUBLIC CITIZEN UPDATED THIS PRESS RELEASE. FOR THAT UPDATED INFORMATION, VISIT THIS PAGE.

Aug. 31, 2000

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.

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