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Appleton v. Food and Drug Administration

February 27, 2003

BURTON L. APPLETON, PLAINTIFF,
v.
FOOD AND DRUG ADMINISTRATION AND DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEFENDANTS.



The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document Nos.: 10, 13, 18, 23, 26, 28

MEMORANDUM OPINION

GRANTING IN PART THE DEFENDANTS' MOTION FOR AN OPEN AMERICA STAY; DENYING WITHOUT PREJUDICE THE MOTIONS TO INTERVENE

I. INTRODUCTION

Plaintiff Burton Appleton, a former Food and Drug Administration ("FDA") chemist, brings this action pro se to compel FDA to reply fully to his Freedom of Information Act ("FOIA") request for records regarding the drug levothyroxine sodium. Defendants FDA and the Department of Health and Human Services ("HHS") have submitted a partial answer and a motion for a stay of proceedings pending the completion of their search and production of documents pursuant to the FOIA request (known as an Open America stay). In addition, Jerome Stevens Pharmaceuticals, Inc., Jones Pharma, Inc., Abbott Laboratories, Lloyd Inc., and Vintage Pharmaceuticals, Inc. have filed motions to intervene. For the reasons that follow, the court grants in part and holds in abeyance in part the defendants' motion for an Open America stay, and denies without prejudice the motions to intervene.

II. BACKGROUND

A. Factual Background

In September 2001, the plaintiff submitted a FOIA request to FDA, requesting "any and all records concerning communications 1) between [FDA] and the United States Pharmacopeia ["USP"] . . . and 2) within the FDA on the subject of the drug levothryoxine sodium." Compl. Ex. 1. Specifically, he asked for communications - including letters, faxes, e-mails, memoranda, and directives - from August 14, 1997 to the present regarding orally administered and injectable dosage forms of the drug. Id.

In response to the plaintiff's request, FDA responded four times. *fn1 On October 4, 2001, FDA responded with a brief letter acknowledging receipt of the plaintiff's request, assigning it a file number, and stating that the agency would respond "as soon as possible." Defs.' Mot. for Stay Ex. 1B. On November 1, 2001, FDA sent a second, more substantive response noting that information on a certain relevant new drug application (Unithroid) was available on FDA's website, that information on another relevant new drug application (Levoxyl) required redaction before release, and that a search was underway for the FDA/USP communications. Id. Ex. 2A. On December 7, 2001, FDA sent the plaintiff redacted information on the Levoxyl application. Id. Ex. 2B. Finally, on January 2, 2002, FDA forwarded material on FOIA law and regulations to the plaintiff. *fn2 Compl. Ex. 2.

On January 25, 2002, the plaintiff wrote to FDA to raise concerns regarding the agency's responses, and to amend his original request. Id. Specifically, the plaintiff highlighted what he believed to be various insufficiencies in the FDA responses, such as inaccurate paraphrasing of his request, missing documents, and unnecessary redactions. Id. He also amended his request to enlarge the time frame from August 14, 1997 to "the first time that the FDA began to look into the regulation of the drug." Id. At the same time, he clarified the parameters of his request (stating, for example, that his request was intended to focus primarily on chemistry information, with biopharmaceutical information requested only insofar as it invoked analytical chemistry methodology not elsewhere disclosed). Id.

After receiving no response from FDA, on March 26, 2002 the plaintiff faxed a letter to HHS to appeal FDA's denial of his FOIA request. Id. Ex. 3. On March 28, 2002, at the direction of HHS staff, the plaintiff redirected his fax to a different number. Id. Ex. 4. On March 28 and 29, 2002, the plaintiff received acknowledgment of his appeal. Id. On May 8, 2002, after receiving no substantive response to his March letter, the plaintiff again wrote to HHS to stress what he believed were FDA's "repeated failures" to abide by FOIA and to ask for information in order to avoid "go[ing] to federal district court prematurely." Id.

B. Procedural History

On May 29, 2002, the plaintiff filed a complaint with this court. On July 1, 2002, the defendants filed a partial answer accompanied by a motion requesting an Open America stay of proceedings through March 15, 2004. Subsequently, five pharmaceutical manufacturers - Jerome Stevens Pharmaceuticals, Inc., Jones Pharma, Inc., Abbott ...


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