FDA Debars Research Site Owners Who Faked Trial Data

FDA has permanently debarred Ricardo Andres Acuna and Angela Anatilde Baquero, the owners of a Florida clinical trial site, from ever again providing services to a company with an approved or pending drug application before the agency. Two Final Debarment Orders, published in the Federal Register on 3 August 2026, close out a case that began with a sponsor's audit of suspicious spirometry readings and ended with guilty pleas to conspiracy to commit wire fraud.

How the fraud surfaced

A&R Research Group conducted clinical trials on behalf of drug sponsors seeking FDA approval. According to the underlying criminal case, Acuna and Baquero conspired to unlawfully enrich themselves by making fraudulent representations to the asthma-drug trial's sponsor about subject eligibility, and by falsifying and fabricating material documents and data — case histories, spirometry readings, and echocardiogram data among them. The scheme did not stay contained to the sponsor's own oversight: FDA's order describes the same fabricated case histories being handed to an FDA investigator during an official inspection, which is what turns a contract dispute into a federal debarment case.

Acuna, 52, and Baquero, 49, both of Weston, Florida, pleaded guilty in March 2025 in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud, a felony. A third person connected to the same site, the trial's clinical investigator, pleaded guilty separately to making false statements to FDA officials — a related but distinct case, and not one of the two debarment orders published this week.

What debarment actually bars

FDA debarment is a specific, and permanent, professional exclusion: once debarred under section 306(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act, a person may not provide services in any capacity to a company that has an approved or pending drug product application before the agency. It is broader than a bar on running trials — it covers any role at any sponsor, CRO, or other company with FDA drug business, for life, with no term to wait out. FDA sent both Acuna and Baquero a notice of opportunity for a hearing; neither responded within the deadline, which FDA treats as a waiver of that right and clears the way for a final order rather than a contested proceeding.

The data-integrity angle

For sponsors and CROs, the operationally relevant detail is not the criminal case but the debarment list itself: FDA maintains it, and a site or individual's presence on it is a standard part of investigator and vendor due diligence before a trial starts. This case is also a reminder of where fabrication tends to get caught — not in the data as submitted, but in an audit that does not match what the data claims. The sponsor's own audit flagged the irregular readings that led here; the FDA inspection that followed is what made the fabrication a federal case rather than a terminated contract.