SUPPLEMENTARY INFORMATION:

I. Background

Section 306(b)(1)(D) of the FD&C Act permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On March 5, 2026, Mr. Kumar was convicted as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for the Southern District of Texas, when the court accepted his plea of guilty and entered judgment against him for the felony offense of conspiracy to traffic in counterfeit goods in violation of 18 U.S.C. 2320(a)(4) and (b)(3)(A). ( printed page 60381) The underlying facts supporting the conviction are as follows:

As contained in the Indictment and in the Plea Agreement from his case, Mr. Kumar knowingly sold pharmaceutical products bearing counterfeit marks which he caused to be imported into the United States. Among the drugs illegally sold by Mr. Kumar was Keytruda, a prescription drug used to treat cancer. However, the counterfeit Keytruda he sold did not contain the active ingredient for Keytruda. Merck Sharp & Dohme LLC, formerly known as Merck Sharp & Dohme Corp. (“Merck”), had the exclusive right to authorize the manufacture of Keytruda for distribution within the U.S. and owned the trademarks for the designs and word marks used by Merck to identify Keytruda and other Merck products.

Beginning in or around August 2018 until approximately on or about June 26, 2024, Mr. Kumar, with the aid of co-conspirators, intentionally conspired to, and did traffic Keytruda bearing counterfeit marks into the United States. During the course of his criminal conspiracy, Mr. Kumar and his co-conspirators negotiated numerous sales of pharmaceuticals with counterfeit marks to both agents of a private company working with law enforcement and agents from U.S. Homeland Security Investigations, acting in an undercover capacity. Over years, these agents texted with members of the conspiracy, including Mr. Kumar, concerning the placement of orders, payments, and shipments of pharmaceuticals to the United States. In addition to other sales of Keytruda bearing counterfeit marks during this period, Mr. Kumar, with the assistance of his co-conspirators, sold the following quantities of Keytruda using counterfeit marks to agents: on January 30, 2020 he sold 1 x 50mg vial of Keytruda for $2,500; on March 28, 2023, he sold 2 x 100mg of Keytruda for $3,500; on May 8, 2023, he sold 2 x 100mg Keytruda for $5,998; and, on June 20, 2023, he sold 2 x 100mg of Keytruda for $3,500. At Mr. Kumar's direction, the aforementioned drugs were shipped by co-conspirators to Houston, Texas. The undercover agents wired each payment to Indian-based bank accounts as directed by Mr. Kumar and his co-conspirators.

Laboratory testing concluded that Mr. Kumar sold Keytruda bearing counterfeit marks into the United States, and that these drugs violated the trademarks registered to Merck in the principal registry in the U.S. Patent and Trademark Office. The Keytruda bearing the counterfeit marks was chemically inconsistent with genuine Keytruda and did not contain the active ingredient necessary for the drug to serve its medical purpose. Instead, the Keytruda bearing the counterfeit marks sold by Mr. Kumar and his co-conspirators included fillers and adulterants that served no legitimate function for treating cancer. The packaging of the pharmaceuticals he sold purported to be Merck brand Keytruda packaged in containers that bore trademarks that were substantially indistinguishable from the genuine marks registered to Merck and used to identify genuine Keytruda. Furthermore, the packages bearing counterfeit marks often contained false lot numbers, invalid expiry dates, and misspellings. Over the course of the conspiracy, Mr. Kumar and his co-conspirators received approximately $89,268 for their sales of Keytruda using counterfeit marks to undercover agents, with a total wholesale acquisition cost value of approximately $127,465.72.

On June 26, 2024, Mr. Kumar met with undercover agents in a hotel in Houston, Texas. He believed that these agents were future business partners and purchasers. During part of the meeting, he also dialed in a co-conspirator, whom he explained could provide the agents with detailed information on the pharmaceuticals he was able to source. During this meeting, Mr. Kumar expressed his intention to form a long-term business partnership with the undercover agents, assuring the agents that they would all profit. He explained that he had been in this business for more than 10 years, and that, at a global level, his pharmaceutical company, MediPharma, was shipping more than a hundred pharmaceutical parcels per day. He explained that his previous company, Reliable Chemist, was shut down after his employees and business partners were arrested by Indian authorities after selling “fake” Keytruda. Mr. Kumar also made it clear that he understood the risks posed by counterfeit pharmaceuticals and raised these with agents, explaining that counterfeit Keytruda would not work to treat cancer and was “just like water.” Despite these risks, he committed to sourcing 50 units (100-mg vial) of counterfeit Keytruda for the agents over the next few days, while he remained in the United States, as a start to their business relationship. Further, according to information provided by Mr. Kumar and his co-conspirator, his company was presently capable of sending 100 units of Keytruda (100-mg vial) a month, or weekly batches of up to 20 units. During a discussion of the logistics for selling hundreds of units of Keytruda into the United States, Mr. Kumar detailed how his company was able to avoid possible issues with U.S. and Indian customs.

FDA sent Mr. Kumar, by certified mail, on May 20, 2026, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Kumar's felony conviction under Federal law for conspiracy to traffic in counterfeit goods in violation of 18 U.S.C. 2320(a)(4) and (b)(3)(A) was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Kumar illegally imported and introduced misbranded and counterfeit prescription drug products into interstate commerce.

In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Mr. Kumar's offense and concluded that the offense warranted the imposition of a 5-year period of debarment. The proposal informed Mr. Kumar of the proposed debarment and offered him 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 request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Kumar received the proposal and notice of opportunity for a hearing on May 28, 2026. Mr. Kumar failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Sanjay Kumar has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Kumar is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for ( printed page 60382) import into the United States of any drug by, with the assistance of, or at the direction of Mr. Kumar during his period of debarment is a prohibited act.

91 FR 60380