SUPPLEMENTARY INFORMATION:

I. Background

Section 306(a)(2)(B) of the FD&C Act requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act.

On October 5, 2023, Ms. Acosta was convicted as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for the Eastern District of Texas-Beaumont Division, when the court accepted her plea of guilty and entered judgment against her for the felony offense of Conspiracy to Traffick in Drugs with Counterfeit Mark in violation of 18 U.S.C. 371 and 18 U.S.C. 2320(a)(4). The underlying facts supporting the conviction are as follows: as contained in the Second Superseding Indictment and the Factual Basis, between April 2014 until February 2021, Ms. Acosta was involved in a conspiracy with drug traffickers to distribute misbranded and counterfeit cough syrup. Specifically, Ms. Acosta worked for Woodfield Pharmaceutical, LLC as a packaging supervisor. Woodfield Pharmaceutical, LLC was a part of a group of pharmaceutical companies, which included Woodfield Pharmaceutical, LLC, a contract manufacturing company, and Woodfield Distribution. LLC, a third-party logistics company (collectively, “Woodfield”). On April 25, 2014, Woodfield acquired Pernix Manufacturing, LLC (Pernix). Pernix had, in January 2014, entered into an agreement with Byron A. Marshall and his Drug Trafficking Organization (DTO) to copy and manufacture cough syrup according to the directions of Marshall and his associates.

Marshall was not licensed or authorized to distribute cough syrup and any background check of the personal information provided by Marshall to Pernix or later Woodfield would have revealed that he was not a licensed physician as he claimed. Initially, Marshall sought to copy Actavis Prometh VC with Codeine (Actavis). Actavis is a purple, peach-mint flavored prescription cough syrup that was in demand as a street drug. Marshall and his associates wanted to mass produce and traffic a counterfeit version of Actavis that contained promethazine, but not codeine. On April 24, 2014, Actavis Holdco US discontinued production of Actavis due to its widespread abuse by recreational drug users. A Pernix product-development scientist worked with Marshall and his associates to re-create the Actavis product without codeine and promethazine in order to re-create the syrup base, which is a necessary component of cough syrup. Marshall and his associates would add promethazine to the counterfeit substance prior to bottling and distribution in order to create the street drug. Marshall and his DTO also obtained counterfeited commercial-grade pharmaceutical labels designed to look exactly like the genuine labels for the prescription cough syrup from another supplier. Later in the conspiracy, Marshall and his DTO asked Woodfield employees to reformulate other cough syrup to use in their drug trafficking scheme to include Hi-Tech Promethazine Hydrocholoride and Codeine Phosphate Oral Solution (Hi-Tech) and Wockhardt Promethazine Syrup Plain (Wockhardt).

In her position within Woodfield, Ms. Acosta assisted in the packaging and delivery of the counterfeit cough syrup. In addition, between February 2019 through March 2021, Ms. Acosta was the principal point of contact between the owner of Woodfield, Adam Runsdorf, and the Marshall DTO. Ms. Acosta also was the principal conduit for cash from the Marshall DTO to Runsdorf.

From 2014 through February 2021, the conspiracy between the Marshall DTO produced and distributed, or attempted to produce and distribute, approximately 65,920 gallons of counterfeit cough syrup. ( printed page 42476)

FDA sent Ms. Acosta, by certified mail, on January 30, 2024, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Ms. Acosta was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal informed Ms. Acosta of the proposed debarment and offered her an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Acosta received the proposal and notice of opportunity for a hearing on February 5, 2024. Ms. Acosta failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and waived any contentions concerning her debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Ms. Gina Acosta has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act.

As a result of the foregoing finding, Ms. Acosta is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application, effective (see DATES ) (see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses in any capacity the services of Ms. Acosta during her debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. Acosta provides services in any capacity to a person with an approved or pending drug product application during her period of debarment, she will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug application from Ms. Acosta during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306 and 307 of the FD&C Act, a “drug product” is defined as a “drug subject to regulation under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262)” (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).

89 FR 42474