Ronald J. Mannino
Joseph M. Pizza
InterChem Trading Corp.
120 Route 17 North
Paramus, New Jersey 07652
Re: Employment of Daphne (Pai) Lau, a debarred
individual;
58 Fed. Reg. 59048 (Nov. 5, 1993)
Dear Messrs. Mannino and Pizza:
The United States Food and Drug Administration (FDA) has learned of your employment of Daphne (Pai) Lau. Daphne (Pai) Lau was debarred from providing services in any capacity to a person with an approved or pending drug product application, under the Generic Drug Enforcement Act (GDEA), 58 Fed. Reg. 59048 (Nov. 5, 1993). As explained in this letter, Ms. Lau's employment with you violates her debarment.
The question of whether a person is providing services in any capacity to a person with an approved or pending drug product application does not turn on the presence of an immediate employer/employee relationship. InterChem is the United States agent to ACS Dobfar, a company with numerous drug product applications. Additionally, many of your suppliers and customers have drug product applications. Based on the information available to FDA, Daphne (Pai) Lau's duties include assisting InterChem in evaluating active pharmaceutical ingredients to determine the intermediate chemicals needed for their manufacture.
The GDEA prohibits a debarred person from providing "services in any capacity to a person that has an approved or pending drug product application." 21 U.S.C. § 335a(a). This statutory prohibition includes any relationship which provides a debarred person with an opportunity for regular and frequent contact - and the related potential for influence - with the pharmaceutical industry. See Dicola v. FDA, 77 F.2d 504, 507, 509 (D.C. Cir. 1996). Here, it is not sufficient to consider only whether your firm, InterChem, as Daphne (Pai) Lau's employer, has approved or pending drug product applications. The pertinent query is whether InterChem provides services in any capacity to a person with such applications.
Under the GDEA, a "drug product" is "a drug subject to regulation under section 505, 512, or 802 of [the Federal Food, Drug, and Cosmetic Act] or under section 351 of the Public Health Service Act." 21 U.S.C. § 321(dd). This statutory definition encompasses all types of regulation under the specified provisions of the Act; there is no basis in the Act to limit the definition of a "drug product application" under the GDEA to applications for finished dosage form pharmaceuticals. Any distinction between bulk or finished dosage form drug products is without basis or effect.
This letter is to inform you that your
employment of Daphne (Pai) Lau violates the debarment order. 58
Fed. Reg. 59048 (Nov. 5, 1993). Please advise FDA within 10 days
of any action you have taken to correct this violation. Please
send your response to:
Food and Drug Administration
New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, New Jersey 07054
ATTN: Diane E. Boucher, Compliance Officer
and
Food and Drug Administration
Center for Drug Evaluation and Research
5600 Fishers Lane, HFD-7
Rockville, MD 20857
ATTN: Leanne Cusumano, Regulatory Counsel
A failure to take corrective action by terminating this employment relationship or by responding to this letter may result in the imposition of civil penalties, 21 U.S.C. § 335b, or other enforcement action.
Sincerely yours,
Douglas I. Ellsworth
New Jersey District Director