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, Mrs. Baquero 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 her plea of guilty and entered judgment against her 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 Mrs. Baquero's case, between about January 2019 and January 2020, Mrs. Baquero engaged in a conspiracy to defraud the United States through her role as co-owner and clinical research director of A&R Research Group LLC (A&R), a medical research clinic conducting clinical drug trials. Along with her husband Ricardo Acuna, who served as regulatory and contract affairs manager, Mrs. Baquero orchestrated a scheme to unlawfully enrich themselves by falsifying data and making fraudulent representations while conducting two asthma clinical trials sponsored by a pharmaceutical company.

A&R contracted with a drug sponsor through a Contract Research Organization (CRO) to conduct trials for investigational drugs treating moderate to severe asthma and mild to moderate asthma. The company received $320,247.98 for these trials. Mrs. Baquero served as study coordinator, responsible for recruiting subjects, maintaining case histories, and communicating with sponsors. She signed delegation logs acknowledging her responsibilities to perform certain tasks as part of the trials and received protocol training from the CRO prior to beginning the asthma trials. Mrs. Baquero understood that A&R was required to conduct trials honestly, accurately, and in accordance with Federal regulations and clinical trial protocols, and that the sponsor, CRO, and FDA could audit the trial site at any time.

The conspiracy's purpose was twofold: first, to make false representations about subject eligibility and participation to secure payments from the sponsor and CRO; second, to falsify and fabricate material documents including case histories, spirometry readings, electrocardiogram data, and other trial data. Mrs. Baquero and her co-conspirators knowingly failed to conduct the clinical trials according to their protocols and applicable Federal regulations.

To inflate payments received from the sponsor, Mrs. Baquero and two co-conspirators obtained fake medical records for at least 17 trial subjects who lacked legitimate documentation of qualifying asthma diagnoses. She provided Co-Conspirator 1 and Co-Conspirator 2 with eligibility criteria needed to create fraudulent medical records, which they then purchased for themselves and others. Upon receiving these fake records, Mrs. Baquero directed Mr. Acuna to pay the co-conspirators for obtaining them. She then enrolled these subjects in the asthma trials using the falsified documentation. In one instance, Mrs. Baquero enrolled Co-Conspirator 1 in Asthma Trial 1 on March 22, 2019, despite knowing this individual used a fake driver's license, participated under a false identity, and was simultaneously enrolled in another A&R trial under their real name.

Mrs. Baquero furthered the conspiracy by obtaining false study assessments and blood samples to conceal the fact that those subjects enrolled in the asthma trials were not qualified for and were not participating in the trials. On March 4, 2019, she personally performed a spirometry reading while pretending to be a trial subject. She also had Co-Conspirator 1 and Co-Conspirator 2 perform spirometry readings and provide blood samples for other enrolled subjects, with Mr. Acuna then issuing payments for these fraudulent assessments. These falsified results were submitted to the CRO and sponsor to create the illusion of legitimate trial participation and protocol compliance.

The fabricated medical records and falsified physical examination forms were included in subjects' case histories. When the sponsor conducted an in-person audit in August 2019 due to suspicious spirometry and electrocardiogram readings, Mrs. Baquero and the clinical investigator knowingly provided case histories containing falsified data. On January 24, 2020, these same fraudulent case histories, containing fake medical records, falsified clinical data, and documentation of payments to non-participating subjects, were provided to an FDA investigator during an official inspection.

Through these false and fraudulent representations, Mrs. Baquero's conduct resulted in A&R receiving the full $320,247.98 payment from the sponsor, enriching herself and Mr. Acuna as joint owners of the company while compromising the integrity of clinical research intended to ensure drug safety and efficacy.

As a result of this conviction, FDA sent Mrs. Baquero, by certified mail, on March 27, 2026, 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)(A) of the FD&C Act, that Mrs. Baquero 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 Mrs. Baquero 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 a waiver of any contentions concerning this action. Mrs. Baquero received the proposal and notice of opportunity for a hearing on April 6, 2026. Mrs. Baquero 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 Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(a)(2)(A) of the FD&C Act, ( printed page 48877) under authority delegated to the Director, Division of Enforcement, finds that Mrs. Angela Anatilde Baquero 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, Mrs. Baquero 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 Mrs. Baquero 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 Mrs. Baquero 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 Mrs. Baquero 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, 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 48875