FR DATE:03/24/2005

[Federal Register: March 24, 2005 (Volume 70, Number 56)]

[Notices]               
[Page 15106-15107]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr05-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001N-0541]

 
Eduardo Caro Acevedo; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. 
Eduardo Caro Acevedo for 5 years from providing services in any 
capacity to a person that has an approved or pending drug product 
application. FDA bases this order on a finding that Dr. Caro was 
convicted of a felony under Federal law for engaging in a conspiracy to 
defraud the United States and has demonstrated a pattern of conduct 
sufficient to find that there is reason to believe that he may violate 
requirements under the act relating to drug products. Dr. Caro failed 
to request a hearing and, therefore, has waived his opportunity for a 
hearing concerning this action.

DATES: This order is effective March 24, 2005.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 16, 2001, the U.S. District Court for the District of 
Puerto Rico accepted Dr. Eduardo Caro Acevedo's plea of guilty to one 
count of conspiracy to offer and pay kickbacks in

[[Page 15107]]

relation to the referral of Medicare beneficiaries to a durable medical 
equipment company, in violation of the Medicare antikickback law (42 
U.S.C. 1320a-7b), and in violation of 18 U.S.C. 371. The court 
sentenced Dr. Caro to 2 years probation for the offense (United States 
v. Eduardo Caro, Docket No. 00CR020-05 (SEC) (D.P.R. July 13, 2001)).
    At the time of Dr. Caro's criminal actions, he was a physician 
authorized to practice medicine in Puerto Rico as a Medicare provider 
and was authorized to prescribe, among other things, durable medical 
equipment to Medicare beneficiaries. The owner of a durable medical 
equipment company, authorized to sell to Medicare beneficiaries, 
offered and paid money to Dr. Caro to unlawfully induce him to refer 
patients to the medical equipment company. Dr. Caro received money in 
return for referring patients to the company for the furnishing of 
durable medical equipment and services payable under the Medicare 
program, the specific amount depending on the value of the service or 
equipment referred to the company. The unlawful kickback payments made 
to Dr. Caro allowed the company to improperly invoice Medicare for 
approximately $11,940.
    In addition, Dr. Caro demonstrated a pattern of conduct sufficient 
to find reason to believe that he may violate requirements under the 
act relating to drug products. In July 2002, FDA issued Dr. Caro a 
Notice of Disqualification to Receive Investigational New Drugs. This 
action was based upon repeated and deliberate submissions of false 
information to drug sponsors in required reports for studies of 
investigational new drugs that are subject to section 505 of the act. 
In addition, Dr. Caro repeatedly and deliberately failed to comply with 
regulations governing the conduct of clinical investigators and the use 
of investigational new drugs in conducting two protocols sponsored by 
Daiichi Pharmaceutical Corp. Among other things, he submitted false 
information in required reports, deviated from protocols, maintained 
inaccurate and inadequate study records, failed to report adverse 
events, failed to properly account for the disposition of study 
medications, failed to obtain adequate institutional review board 
approval, and failed to obtain proper consent from study subjects or 
their legally authorized representatives. As a result, he is no longer 
entitled to receive investigational new drugs (Notice of 
Disqualification to Receive Investigational New Drugs, July 30, 2002).
    As a result of Dr. Caro's conviction and pattern of conduct, FDA 
served him by certified mail on February 18, 2004, a notice proposing 
to debar him for 5 years from providing services in any capacity to a 
person that has an approved or pending drug product application. The 
proposal also offered Dr. Caro an opportunity for a hearing on the 
proposal. The proposal was based on a finding, under section 
306(b)(2)(B)(ii) of the act (21 U.S.C. 335a(b)(2)(B)(ii)), that Dr. 
Caro was convicted of a felony under Federal law for engaging in a 
conspiracy to defraud the United States and has demonstrated a pattern 
of conduct sufficient to find that there is reason to believe that he 
may violate requirements under the act relating to drug products. Dr. 
Caro was provided 30 days to file objections and request a hearing. Dr. 
Caro did not request a hearing. His failure to request a hearing 
constitutes a waiver of his opportunity for a hearing and a waiver of 
any contentions concerning his debarment.

II. Findings and Order

    Therefore, the Director, Center for Drug Evaluation and Research, 
under section 306(b)(2)(B)(ii) of the act and under authority delegated 
to him (Staff Manual Guide 1410.035), finds that Dr. Eduardo Caro 
Acevedo has been convicted of a felony under Federal law for engaging 
in a conspiracy to defraud the United States and has demonstrated a 
pattern of conduct sufficient to find that there is reason to believe 
that he may violate requirements under the act relating to drug 
products.
    As a result of the foregoing findings, Dr. Caro is debarred for 5 
years from providing services in any capacity to a person with an 
approved or pending drug product application under sections 505, 512, 
or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 
of the Public Health Service Act (42 U.S.C. 262), effective March 24, 
2005 (see sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the 
act (21 U.S.C. 321(dd))). Any person with an approved or pending drug 
product application who knowingly uses the services of Dr. Caro, in any 
capacity, during his period of debarment, will be subject to civil 
money penalties (section 307(a)(6) of the act (21 U.S.C. 355b(a)(6))). 
If Dr. Caro, during his period of debarment, provides services in any 
capacity to a person with an approved or pending drug product 
application, he will be subject to civil money penalties (section 
307(a)(7) of the act). In addition, FDA will not accept or review any 
abbreviated new drug applications submitted by or with the assistance 
of Dr. Caro during his period of debarment.
    Any application by Dr. Caro for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 
2001N-0541 and sent to the Division of Dockets Management (see 
ADDRESSES). All such submissions are to be filed in four copies. The 
public availability of information in these submissions is governed by 
21 CFR 10.20(j). Publicly available submissions may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: March 5, 2005.
Steven K. Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-5781 Filed 3-23-05; 8:45 am]

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