SUPPLEMENTARY INFORMATION:

I. Background

Section 306(a)(2)(A) 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 development or approval, including the process of development or approval, of any drug product under the FD&C Act.

On January 14, 2026, Mr. Acuna 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 Florida, Fort Lauderdale Division, when the court accepted his plea of guilty and entered judgment against him for conspiracy to commit wire fraud against the United States in violation of 18 U.S.C. 371. The underlying facts supporting the conviction are as follows:

As contained in the Information and in the Factual Proffer in Support of Guilty Plea from Mr. Acuna's case, between about January 2019 and January 2020, Mr. Acuna conspired with others to defraud a pharmaceutical sponsor conducting clinical trials for asthma medications. As co-owner of A&R Research Group LLC (A&R) with his wife Angela Baquero, Mr. Acuna served as the regulatory and contract affairs manager, responsible for maintaining study documents, collecting signatures, completing required forms, and serving as the primary contact for sponsors. Mrs. Baquero acted as clinical research director and study coordinator of A&R which partnered with a licensed Florida physician who served as the clinical investigator for all trials.

A&R conducted two clinical trials for investigational asthma drugs, receiving $320,247.98 from the sponsor. Mr. Acuna signed Clinical Trial Agreements with the Contract Research Organization (CRO) representing the sponsor, acknowledging A&R's obligation to follow trial protocols and applicable Federal regulations. He also signed Site Delegation Authority Logs and received training from the CRO, demonstrating his knowledge of the requirements and his delegated responsibilities. Mr. Acuna understood that the sponsor, CRO, and FDA could audit the trial site at any time and that A&R was required to cooperate fully with auditors.

The conspiracy's purpose was to unlawfully enrich Mr. Acuna and his co-conspirators through two primary schemes: making false representations about subject eligibility and participation to secure payments from the sponsor and/or CRO, and falsifying material trial documents and data, including case histories, spirometry readings, echocardiogram data, and other data.

Mr. Acuna and his co-conspirators knowingly failed to conduct the trials according to the trial protocols and applicable federal regulations. Mrs. Baquero, along with Co-Conspirator 1 and Co-Conspirator 2, obtained fake medical records for at least 17 trial subjects who lacked legitimate documentation of qualifying asthma diagnoses. Mr. Acuna facilitated this fraud by issuing payments to the co-conspirators for obtaining these false records. For instance, on June 12, 2019, Mr. Acuna signed a check for $120 to Co-Conspirator 1 for fake medical records for two subjects.

The fraud extended beyond falsified enrollment documents. Mrs. Baquero directed Co-Conspirator 1 and Co-Conspirator 2 to perform spirometry readings and provide blood samples on behalf of other enrolled subjects, and Mr. Acuna issued payments for these fraudulent assessments. On May 28, 2019, Mr. Acuna signed a check for $150 to Co-Conspirator 2 for “4 Spriometries,” knowing this compensated the co-conspirator for performing tests on behalf of other subjects. Significantly, Mr. Acuna did not include this payment in any trial-related records. These fraudulent spirometry readings and blood samples were submitted to the CRO and sponsor to create the false impression that subjects were participating properly and that A&R was conducting the studies in accordance with the clinical trial protocols.

In August 2019, based in part on suspicious spirometry and echocardiogram readings, the sponsor conducted an in-person audit of A&R. During this audit, Mr. Acuna and Mrs. Baquero provided case histories that they knew contained records of payments to subjects who had not actually participated in the studies. On January 24, 2020, these same fraudulent case histories were provided to an FDA investigator during an official inspection. Through these false and fraudulent representations regarding the asthma trials, Mr. Acuna's conduct resulted in A&R receiving the full $320,247.98 payment from the sponsor, enriching both himself and Mrs. Baquero as joint owners and controllers of the company.

As a result of this conviction, FDA sent Mr. Acuna, by certified mail, on March 27, 2026, 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)(A) of the FD&C Act that Mr. Acuna was convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product. The proposal informed Mr. Acuna 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 a waiver of any contentions concerning this action. Mr. Acuna received the proposal and notice of opportunity for a hearing on April 6, 2026. Mr. Acuna 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(a)(2)(A) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Ricardo Andres Acuna has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process of development or approval, of any drug product.

As a result of the foregoing finding, Mr. Acuna 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)(A) 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. Acuna 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. Acuna 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 drug application from Mr. Acuna during his period of ( printed page 48879) 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, 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))).

91 FR 48877