Falsified spirometry readings, fabricated echocardiogram data, and case histories for patients who never existed were submitted into the clinical trial database systems the FDA uses to evaluate new drugs for approval [1]. The data came from asthma drug trials conducted at two Pembroke Pines, Florida research facilities between 2019 and 2025 [1][2].
Dr. Jaynier Moya, 49, was charged this week with conspiracy to commit wire fraud and three counts of substantive wire fraud [1]. He co-owned Pines Care Research Center LLC and served as principal investigator for the research studies [1].
Three clinical research coordinators at Pines Care were charged alongside him: Luis Montano, 55; Yuniarka Garcia, 41; and Alexandra Olivera, 38 [1]. Each faces the same conspiracy charge. Montano and Garcia face three additional counts of substantive wire fraud [1].
The charging documents allege they used identification documents from people who did not participate in the trials to create false records [1]. The fabricated testing data was then submitted to pharmaceutical development companies sponsoring the trials [1].
Each count of wire fraud carries a statutory maximum penalty of 20 years in prison [1].
A&R Research Group
Angela Baquero, 49, and Ricardo Acuna, 52, owned a second Pembroke Pines research facility called A&R Research Group [2]. Both have already pleaded guilty to conspiracy to commit wire fraud [2].
Baquero served as A&R's clinical research director and study coordinator. Acuna served as regulatory and contract affairs manager [2]. In their plea agreements, they admitted to falsifying and fabricating case histories, spirometry readings, and echocardiogram data in asthma drug trials conducted on behalf of drug sponsors seeking FDA approval [2].
They also admitted they "fraudulently enrolled subjects who did not qualify and submitted data for subjects who were not participating to inflate payments from the sponsor" [2].
Read that again. The fabrication had two purposes: to make unqualified subjects appear eligible, and to bill for subjects who were not participating at all.
Dr. Matthew Teltser, 70, served as clinical investigator for numerous A&R clinical trials [2]. He pleaded guilty March 3 to making false statements to an FDA investigator [2].
Teltser admitted he falsely told the investigator that he had been present at every subject visit during two asthma clinical trials [2]. He faces a maximum penalty of five years in prison [2]. Baquero and Acuna face the same maximum [2].
Two facilities, same city, same scheme
Both research sites operated in Pembroke Pines [1][2]. Both ran trials for asthma drugs [1][2]. Both fabricated the same types of data: spirometry readings, echocardiogram results, patient case histories [1][2].
The scheme at Pines Care began no later than 2019 [1]. The Justice Department has not stated when the A&R scheme began, but Teltser's false statement to the FDA investigator concerned trials that would have overlapped with that timeframe [2].
The falsified data entered clinical trial database systems used for evaluating prospective new drugs [1]. Those systems feed the FDA's approval process.
The Justice Department has not identified which asthma drugs were being tested in the trials, whether any received FDA approval, or what happens to approval decisions based on fabricated data [1][2].
Unanswered questions with public health implications
If drugs reached the market based partly on fabricated safety or efficacy data from these sites, patients may currently be taking medications whose approval rested on fraudulent evidence. The FDA has not announced any review of drugs tested at either facility, nor has it disclosed whether it is examining other trials conducted by the convicted researchers. Without such transparency, the integrity of an unknown number of asthma treatments remains in question.
