"FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval"
-> Yes, that sounds super sketchy. The actual testimony doesn't, though it's one sided (below).
The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district attorney asking for the information.
The testimony:
"""
After considering the fact that the investigation results
were preliminary and we had not received formal recommendations
about how to take the results into account in review of the
application, and the fact that only in very rare cases do
inspection results from individual sites lead to the exclusion
of an entire large clinical trial, FDA decided to hold the
Advisory Committee meeting as planned. The Agency made this
decision, knowing that any advice from the Committee would have
to be later taken into account in the context of additional
information about the integrity of data from Study 3014. It is
not unusual for more information to come to FDA for review
after an Advisory Committee meeting is held about an
application. The Advisory Committee voted that the safety and
efficacy of the requested indications had been demonstrated,
based on the information it was provided, including Study 3014,
and limited international post-marketing data provided at the
meeting.
Although the Advisory Committee recommended approval, on
January 23, 2003, (two weeks after the Advisory Committee
meeting) FDA issued another approvable letter to the sponsor
because of the remaining questions about the safety of Ketek.
The letter specifically noted the unresolved data integrity
issues associated with Study 3014 (issues confirmed in the
final clinical inspection summary of the Agency's audits of the
first three clinical trial sites) and the incomplete post-
marketing safety data from foreign countries. FDA noted that
the final decision regarding approval of each indication would
be made after a review of the information and analyses
requested in this letter.
On March 3, 2003, during a closed session of the Advisory
Committee convened to discuss other matters, FDA briefly
explained that an approvable letter was issued because the
Agency wanted to see more information about data from Europe
and Latin America. With regard to Study 3014, FDA explained
that there were unresolved inspectional issues.
Third Cycle. The sponsor submitted a complete response to
the approvable letter in October 2003. The October 2003
submission addressed issues of Study 3014 and included post-
marketing reports for spontaneous adverse events for
approximately four million prescriptions for patients in other
countries where Ketek had already been approved. Upon
completing the review of the sponsor's October submission,
including the findings from the additional audits of clinical
trial sites summarized in a March 2004 memorandum from the
Division of Scientific Investigations, the Agency decided that
it could not rely on Study 3014 to support approval of Ketek
because of the systemic failure of the sponsor's monitoring of
the clinical trial to detect clearly existing data integrity
problems. Accordingly, Study 3014 was dropped for consideration
in making the decision whether to approve Ketek. The Agency
considered data from other clinical trials and the
international post-marketing experience to conclude there was
adequate evidence of safety.
"""