I just found this on www.fda.gov (I'm relieved to know there's no "conflict
of interest" going on)--notice the release date
Sally Myer RN
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FDA News
FOR IMMEDIATE RELEASE
P04-61
June 4, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Review of "Outside Activity" Requests Identifies No Additional Approved
Outside Activities of Concern
Acting Commissioner Dr. Lester M. Crawford Nevertheless
Strengthens FDA Ethics Oversight
Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug
Administration (FDA), today announced the results of a comprehensive review
of all "outside activities" performed by FDA employees. In responding to the
findings of an internal review at FDA of approved outside activities, Dr.
Crawford said: "I am pleased to report, based on the review of all approved
outside activity requests submitted by covered employees, that the review
team did not identify any additional approved outside activities of concern
beyond the one exception that was previously identified and promptly
remedied last month upon discovery. I commend all FDA employees and Center
management for upholding the highest ethical standards. This review has
verified and validated my belief that FDA employees understand the
importance and need for the rules and regulations applicable to the Agency's
outside activities."
As a result of one incident being identified within FDA, Dr. Crawford
directed that a review of all current outside activity requests from FDA
employees be conducted. The purpose of the review was to assess compliance
with the Agency's strict ethical standards as well as with the standards
established by the Office of Government Ethics' Standards of Ethical Conduct
and DHHS and FDA Supplemental Standards of Ethical Conduct Regulations, and
to assure that the outside activities undertaken by FDA employees are in the
public interest.
A team comprised of Jeffrey M. Weber, Associate Commissioner for Management
and FDA's Deputy Ethics Counselor; Dr. Norris Alderson, Associate
Commissioner for Science; Kimberly Holden, Director, Office of Management
Programs; and Jenny Slaughter, Director, Ethics and Integrity Staff, were
tasked with conducting the review and reporting their findings.
The review covered more than 1,800 HHS Form 520's, "Request for Approval of
Outside Activity" for both paid and unpaid work FDA employees perform
outside of their official duties.
"This review shows that the aggressive disclosure and review process
designed to prevent conflicts of interest is working well," said Dr.
Crawford. As a public health and regulatory agency, FDA has consistently
lived up to the highest ethical standards. Nevertheless, I am further
strengthening our disclosure and review program so that the impartiality of
FDA's science-based regulatory decisions will continue to be above
question."
In addition to requiring the director of each product-based FDA center to
personally review all requests for outside activities, a new safeguard
announced last month, FDA today is taking several additional steps to
protect against potential conflicts-of-interest:
a.. Expanding the number of FDA employees required to file declarations of
their financial holdings. For example, although previously only FDA
non-administrative employees at the GS-14 level and above had to file, now
GS-13 non-administrative employees will be included as well.
b.. Announcing that it will conduct an annual review of outside
activities, linking each outside activity to financial disclosure
statements. In the current dynamic environment, an annual review offers
better protection against conflicts of interest.
c.. Issuing an agency-wide "Staff Manual Guide" on outside activities, to
ensure uniform practices across the board.
d.. Developing an electronic version of the new expanded HHS Form 520,
which will allow more rapid and systematic analysis of outside activities.
The review did not identify any additional cases of an approved outside
activity for a covered employee that could pose a concern, beyond the one
instance identified recently regarding the work of an employee of FDA's
Center for Biologics Evaluation and Research (CBER). A previous FDA review
of Form 520s had discovered that the CBER employee's request should not have
been approved. Early last month the CBER employee was informed that his
outside activity was no longer approved, and the employee voluntarily agreed
to sever the relationship.
Today's new measures will go into effect as soon as possible.
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