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114.

Sample Indictment -- Prescription Drug Marketing Act

THE GRAND JURY CHARGES:

COUNT ONE

At all times relevant and material to this Indictment:

Introduction

1. The United States Food and Drug Administration ("FDA") was the agency of the United States responsible for, among other things, enforcing the provisions of the Federal Food, Drug, and Cosmetic Act ("the Act"), Title 21, United States Code, Section 301 et seq.

2. Inderal, Ismo, Lodine, Orudis, Premarin, and Sectral (products of Wyeth-Ayerst Laboratories), Verelan (a product of Wyeth-Ayerst Laboratories and Lederle Laboratories), Micro-K, Quinidex, Reglan, and Tenex (products of A.H. Robins Company), and Feldene, Procardia, and VibraTabs (products of Pfizer Labs Division), among others, were prescription drugs within the meaning of Title 21, United States Code, Section 353(b)(1)(C), in that they were limited by an approved new drug application to use under the professional supervision of a practitioner licensed by law to administer such drugs.

3. "Drug samples" were units of prescription drugs that were not intended to be sold and were intended to promote the sale of the drug. In lawful distribution channels, drug samples were typically packaged in small bubble packs or other small containers and were distributed by drug manufacturing companies free of charge to physicians in order to promote the sale of the drug and encourage physicians to prescribe it to their patients.

The Defendant

4. Defendant XXXXX XXXXXX was a resident of Nowhereseville, New York, within the Western District of New York. Prior to his retirement, he was employed by Wyeth-Ayerst Laboratories as a pharmaceutical sales representative for the Buffalo, New York, area [NOTE: certain names and places changed from original].

The Conspiracy

5. From in or about July 1988, through in or about January 1993, within the Western District of New York and elsewhere, the defendant XXXXXX XXXXXX did knowingly, willfully and unlawfully combine, conspire, confederate, and agree with others both known and unknown to the Grand Jury, to commit offenses against the United States, namely, to knowingly sell, purchase, and trade, and to offer to sell, purchase and trade drug samples in violation of Title 21, United States Code, Section 353(c)(1), 331(t) and 333(b)(1).

Manner and Means

6. It was the purpose and object of the conspiracy that the defendant and his coconspirators would and did, by mutual agreement, purchase and sell prescription drug samples for profit.

7. Among the manner and means whereby the defendant and his coconspirators carried out the objectives of the conspiracy were the following:

a. It was a part of the conspiracy that the defendant and coconspirator 1 would and did purchase drug samples from coconspirator 2 and other persons known and unknown to the Grand Jury.
b. It was further a part of the conspiracy that the defendant and his coconspirators would and did remove drug samples from their original packaging and place them in plastic baggies and other containers.
c. It was further a part of the conspiracy that the defendant and his coconspirators would and did sell drug samples --either in their original packaging or in baggies or other containers -- to pharmacists and other persons in the Buffalo, New York, area and elsewhere.
d. It was further a part of the conspiracy that the defendant and his coconspirators would and did receive cash and checks as payment for their sales of drug samples.
Overt Acts

8. In furtherance of the conspiracy, and in order to effect the objectives thereof, the defendant and his coconspirators committed certain overt acts within the Western District of New York and elsewhere, including, but not limited to, the following:
a. On various occasions during the period 1988 through 1992, XXXXXX XXXXXX met with coconspirators 1 and 2 in Buffalo, New York, and received quantities of drug samples manufactured by Pfizer Labs, including Feldene and Procardia.
b. On or about March 17, 1989, XXXXXX XXXXXX received a check in the amount of $528.76 as payment for drug samples sold to a pharmacist located in Whipsaw, New York.
c. On or about February 17, 1990, XXXXXX XXXXXX received a check in the amount of $1,051.00 as payment for drug samples sold to a pharmacist located in Whipsaw, New York.
d. On or about April 8, 1991, XXXXXX XXXXXX received a check in the amount of $611.10 as payment for drug samples sold to a pharmacist located in Buffalo, New York.
e. On or about August 21, 1992, XXXXXX XXXXXX received a check in the amount of $1,235.00 as payment for drug samples sold to a pharmacist located in Buffalo, New York.
f. In or about December 1992, XXXXXX XXXXXX sold a quantity of drug samples, including Micro-K 10 Extencaps and Lodine, to a pharmacist located in Whipsaw, New York.
g. In or about December 1992, XXXXXX XXXXXX received checks totalling $4,278.40 as payment for, among others, the drug samples referred to in paragraph "f" above.
h. In or about December 1992, XXXXXX XXXXXX possessed a quantity of drug samples, including Inderal LA, Sectral, and Ismo.
All in violation of Title 18, United States Code, Section 371.

COUNT TWO

1. The allegations contained in paragraphs 1 through 4 of Count One of this Indictment are realleged and incorporated by reference as if fully set forth herein.

2. In or about December 1992, within the Western District of New York, the defendant, XXXXXX XXXXXX, did knowingly sell and offer to sell to a pharmacist located in Whipsaw, New York, Micro-K 10 Extencaps, a drug sample within the meaning of Title 21, United States Code, Section 353(c)(1).

All in violation of 21 U.S.C. §§ 331(t) and 333(b)(1).

COUNT THREE

1. The allegations contained in paragraphs 1 through 4 of Count One of this Indictment are realleged and incorporated by reference as if fully set forth herein.

2. In or about December 1992, within the Western District of New York, the defendant, XXXXXX XXXXXX, did knowingly sell and offer to sell to a pharmacist located in Whipsaw, New York, a quantity of Lodine, a drug sample within the meaning of Title 21, United States Code, Section 353(c)(1).

All in violation of 21 U.S.C. §§ 331(t) and 333(b)(1).

A True Bill

[cited in USAM 4-8.230; Civil Resource Manual 113]