The Government Accountability Office found problems with the Food
and Drug Administration's system for debarring and disqualifying
investigators, including long lag times to complete proceedings, and a
system that potentially allows investigators convicted of felonies to
work on a different category of FDA-regulated product, according to an
Oct. 22 report.
“FDA's authority to debar or disqualify clinical
investigators is an important component of its oversight of clinical
investigators, specifically its efforts to protect human subjects and
ensure the integrity of the data upon which it relies when evaluating
new drugs, biologics, or devices for the U.S. market,” the GAO
report concluded. “It is critical for FDA to take action--and to
have the authority to take action--to prevent clinical investigators,
sub-investigators, and study coordinators who engaged in serious
misconduct from doing so again, whether in research that involves
drugs, biologics, or devices.”
Rep. Joe Barton (R-Texas) the top Republican on the House Energy
and Commerce Committee, introduced legislation Oct. 27 to address some
of the concerns in the GAO report.
The report, “Oversight of Clinical Investigators: Action
Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and
Disqualification Processes for Medical Product Investigators”
(GAO-09-807), looked at the length of time and processes FDA takes for
investigator debarments or disqualifications.
The Generic Drug Enforcement Act of 1992 (Pub. L. No. 102-282) gave
FDA the authority to debar individuals who have engaged in research
misconduct, such as submitting fraudulent data. GAO looked at all the
cases that have come through FDA since it received the
disqualification authority in 1992 through Nov. 5, 2008, for a total
of 52 disqualification cases and 18 debarment cases.
Debarment proceedings are mandatory when FDA finds an individual
has been convicted of a federal felony offense relating to the
development or approval of a medical product. FDA also may pursue
“permissive” debarment proceedings under other conditions,
such as a state-level felony conviction for which FDA determines
debarment is appropriate.
For the 18 debarment cases examined for the report, GAO found the
proceedings took anywhere from a year to 11 years, with more than half
taking four or more years. GAO found the permissive proceedings
generally took longer than mandatory proceedings, particularly the
time it took to draft the proposal to
debar.
Control Weaknesses, Competing Priorities.
GAO said FDA identified internal control weaknesses and competing
priorities that led to the delays in completing the debarment
proceedings. For example, FDA said it lacked systematic procedures to
help ensure timely communication of information relevant to debarment,
such as conviction information, and also lacked policies and
procedures that established time frames for debarment actions. Limited
resources also was a contributing factor, FDA said.
In March, FDA released a new staff manual guide designed to
strengthen its internal controls for the debarment process. The new
manual establishes systemic procedures designed to facilitate timely
communication about relevant convictions. The manual sets forth new
time frames as well, such as that FDA is to complete a debarment
proceeding in which an individual fails to respond to a proposal to
debar letter within 350 calendar days of the individual's conviction.
However, the guide does not list any consequences for failing to
debar.
“But the efforts of such actions have yet to be seen,”
the GAO report stated.
For disqualification proceedings, GAO found the length of time
varied from 26 days to more than a decade. About one-third of the
disqualification proceedings took more than two years. GAO reported
that more recent proceedings generally took less time than those
initiated in 1998 to 2001.
“The more steps taken by the clinical investigator to contest
disqualification, the longer it generally took to complete the
proceeding,” the GAO report stated.
Loophole for Medical Devices.
In addition to the lengthy times to conduct the proceedings, GAO
found holes in FDA's debarment authority, noting that the debarment
only pertains to the product that led to the proceeding.
“A study coordinator who was involved in drug research was
debarred as a result of being convicted of a federal felony. This
study coordinator admitted destroying X-ray film reports and
falsifying electrocardiogram results. Despite debarment, this
individual could still provide services for an entity that markets or
intends to market FDA-regulated products other than drugs or
biologics, including medical devices,” GAO stated in the
report.
GAO also found that FDA's debarment authority does not fully extend
to involvement in medical devices.
“While the statute expressly authorizes FDA to debar an
individual from involvement with drugs and biologics, there is no
comparable authority with regard to an individual involved with
medical devices. For example, one investigator who falsely advertised
an unapproved investigational laser device for treating eye disorders
as an FDA-approved device, and who falsified information in the
medical records of patients treated with the device, cannot be
debarred by FDA from working in the medical device industry,”
the report stated.
“A CDRH [FDA Center for Devices and Radiological Health]
official told us that he would like FDA to have the authority to debar
individuals like this investigator. When asked whether the agency had
pursued obtaining this authority, the agency responded that the Office
of the Chief Counsel was not aware of any efforts to expand FDA's
debarment authority, but did not provide a reason for not requesting
this authority.”
GAO Recommendations.
To address the findings in the report, GAO recommended that FDA:
• pursue
debarment authority for medical devices that is consistent with the
current debarment authority for drugs and biologics and prohibit any
debarred individual from involvement with drugs, biologics, and
medical devices;
• amend
agency regulations to ensure that those who have engaged in misconduct
found sufficiently serious to warrant disqualification for one
investigational medical product are not able to continue to serve as
clinical investigators for any other products; and
• monitor
compliance with recently established time frames for debarment and
disqualification proceedings and take appropriate action when those
are not met.
In a statement released Oct. 22, Barton, the top Republican on the
House Energy and Commerce Committee, said the GAO report offers the
latest details of a record of the agency's weakness and failures.
“FDA had failed to make its debarment authority work,”
Barton said. “I think it is especially inexcusable that the
agency can't seem to quickly and consistently debar even convicted
felons.”
Legislation Provisions.
Barton led a group of seven Republicans in introducing the proposed
Strengthening of FDA Integrity Act (H.R. 3932) to require FDA to bring
debarment actions within one year of the date of conviction. The bill
also would close any gaps in FDA's debarment authority to cover all
misconduct relating to the drug or device.
“The problems at FDA are daunting, but I think that a little
common sense and some modest legislating can ensure that American
families will be safe,” Barton said in both the Oct. 22
statement on the report, and a statement on the legislation issued
Oct. 27.
H.R. 3932 also seeks to:
• give
FDA the authority to debar any company or individual who is convicted
of crimes relating to any drug or device;
• give
FDA the authority to debar a medical device company, and not just drug
companies;
• give
FDA the authority to debar companies for any misconduct relating to
the drug or device, not just misconduct that takes place during a drug
or device's development or approval; and
• require
FDA to report to Congress on the number of debarment proceedings
initiated and debarments imposed each year.
By Jeannie Baumann
Text of H.R. 3932 is available at
http://republicans.energycommerce.house.gov/Media/file/News/102709_FDA_Debarment_Bill.PDF.
A copy of the GAO report, officially dated Sept. 25, is available
at
http://www.gao.gov/new.items/d09807.pdf.
Copyright 2009, The Bureau of National Affairs, Inc.