SUPPLEMENTARY INFORMATION: ( printed page 11297)

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 September 7, 2023, Mr. Patel 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 his plea of guilty and entered a judgment against him 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 factual basis for this conviction is as follows: as contained in the Second Superseding Indictment and in the Factual Basis, between approximately April 2014 and February 2021, Mr. Patel conspired with drug traffickers to distribute misbranded and counterfeit cough syrup. Specifically, Mr. Patel worked for Pernix Manufacturing LLC (Pernix) as a product-development scientist. 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 would have revealed that he was not a licensed physician as he claimed. Marshall sought to copy Actavis Prometh VC with Codeine (Actavis). Actavis is a purple, peach-mint flavor 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. In his role at Pernix as a product-development scientist, Mr. Patel worked with Marshall and his associates to recreate Actavis without codeine and promethazine in order to recreate the syrup base, which is a necessary component of cough syrup. Mr. Patel referred to the new product as a “placebo.” Marshall and his associates would then add promethazine to this counterfeit “placebo” substance prior to bottling and distribution in order to create the street drug.

On April 25, 2014, as Pernix was scaling-up production of the “placebo” syrup base, Pernix was acquired by Woodfield Pharmaceutical LLC, a contract manufacturing company, and Woodfield Distribution LLC, a third-party logistics company (collectively, Woodfield). Mr. Patel was subsequently promoted to Woodfield's Research and Development Manager. In that role he supervised Woodfield's chemical formulation development, optimization, and scale-up for clients, and he worked with Marshall and his associates to develop and distribute the misbranded and counterfeit cough syrup. When Marshall and his DTO had difficulty dissolving promethazine into the “placebo” syrup base, Mr. Patel, along with others, worked to resolve that issue.

In or about July 2017, Marshall and his DTO asked Mr. Patel to reformulate another cough syrup to use in their drug trafficking scheme: Hi-Tech Promethazine Hydrocholoride and Codeine Phosphate Oral Solution (Hi-Tech). Mr. Patel reformulated Hi-Tech without the promethazine and codeine, and Woodfield began producing it for Marshall and his DTO. Later, Mr. Patel was promoted to Woodfield's Director of Technical Operations, and in that role, he agreed with other Woodfield employees to create additional “placebo” syrup base supply not authorized by Woodfield's ownership in order to sell that additional supply to Marshall and DTO at a reduced price and split the fee with other Woodfield employees.

On or about December 10, 2019, Marshall and his DTO asked Mr. Patel to reformulate another cough syrup to use in their drug trafficking scheme: Wockhardt Promethazine Syrup Plain (Wockhardt). Mr. Patel reformulated Wockhardt, and Woodfield eventually produced the “placebo” syrup base for Marshall and his DTO.

Initially, there were no batch records to document the production of the “placebo” cough syrups as required; Woodfield provided the syrup to Marshall and his DTO without any corresponding documentation that identified the ingredients of the syrup. This practice continued until February 2019, when Mr. Patel started creating paper records for some of the cough syrup batches Woodfield made for the DTO. Based on the records that do exist and Mr. Patel's own statements, from 2014 through February 2021, the conspiracy with the Marshall DTO produced and distributed, or attempted to produce and distribute, approximately 65,920 gallons of counterfeit cough syrup.

Based on this conviction, FDA sent Mr. Patel by certified mail on October 30, 2023, a notice proposing to permanently debar him 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 Mr. Patel was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal also offered Mr. Patel an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to file a timely request for a hearing would constitute an election not to use the opportunity for a hearing and a waiver of any contentions concerning this action. Mr. Patel received the proposal on November 8, 2023. On December 12, 2023, Mr. Patel submitted correspondence to FDA explaining the reasons why he believed he was not guilty of the offenses he pled guilty to in court. However, in his request he did not request a hearing and has, therefore, waived his opportunity for a hearing and any contentions concerning his 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 Mr. Patel 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, Mr. Patel 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 Mr. Patel during his 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 Mr. Patel provides services in any capacity to a person with an approved or pending drug product application during his period of debarment, he 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 ( printed page 11298) drug application from Mr. Patel during his period of debarment, other than in connection with an audit under 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 11296