[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 160-01-S