Dear Mr. Walker,

We are writing to request that the General Accounting Office (GAO) review the Food and Drug Administration's (FDA) approval of the prescription drug, Claritin.

Over the past two years, the manufacturer of Claritin, Schering-Plough, has proposed creating an administrative process at the Patent and Trademark Office (PTO) to grant patent extensions to compensate for "regulatory delays" during the FDA's review and approval of new drug applications (NDA).

While proponents of this proposal argue that the FDA was responsible for unwarranted delays in the approval of Claritin, critics point out that the product review was slowed by the sponsor's reformulation of the product and by substantial scientific concerns regarding Claritin's carcinogenicity, which arose in the midst of the product's review.

The proposal also follows on the heels of Schering's questionable, long-standing efforts to extend patent protections for Claritin, a prescription antihistamine with over $900 million in annual U.S. sales.  Last year, Schering lobbied the Senate for an amendment to omnibus patent reform legislation for outright five-year patent term extensions for a number of drugs, including Claritin.  In 1996, Schering tried unsuccessfully to attach Claritin patent extensions to the omnibus appropriations bill, the continuing resolution and the agriculture appropriations bill.

In April 1993, the GAO issued a report on "FDA Premarket Approval: Process of Approving Lodine as a Drug" (GAO/HRD-93-81).  The report found that delays in the approval of Lodine were attributable to increases in average new drug approval times, and clinical data submitted by sponsor Wyeth-Ayerst which was "difficult to review" because of "poor organization" and "weaknesses in the clinical data."  Conducting this type of study of Claritin, including a rigorous review of the scientific issues raised during its approval and the quality and adequacy of Schering's application, would be of great assistance.

Please contact our offices with any questions regarding this request.  We look forward to your response.

Sincerely,

REP. SHERROD BROWN
REP. JOHN DINGELL
REP. PETE STARK
REP. HENRY A. WAXMAN

SEN. RICHARD DURBIN
SEN. PATRICK LEAHY
SEN. PAUL WELLSTONE