Newsletter Vol.32, no. 32

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to permit use of treatment INDs earlier in the drug development process
where alternative therapies are unavailable.
o Expanded Access (Parallel Track) IND. Where there is assurance that
adequate clinical trials are in progress and will not be compromised,
patients should have the right to obtain investigational drugs under
expanded access INDs.
o Outside Review of NDAs. To reduce the burden on FDA, sponsors should
have the option of paying FDA for outside review of NDAs by qualified
experts who have no conflict of interest.
o Supplemental NDAs for Manufacturing and other technical modifications to an approved NDA should automatically become effective 180 days
after submission unless FDA specifically rejects the application for
particular safety reasons.
o Insurance Coverage for Investigational Drugs and Ancillary Costs and
marketed drugs prescribed for unlabeled indications, as well as all
ancillary medical care, should be covered by Medicare, Medicaid, and
private insurance if the use has been approved by expert government
agencies, in authoritative medical compendia, or by a committee
established by the Secretary of Health and Human Services to deal with
this matter.
o FDA Resources must be provided at a level commensurate with the
importance of the new drug approval functions for which the agency is
responsible....FDA HOLDS OWN PRESS BRIEFING TO BLAST LASAGNA COMMITTEE & REPORT
"For some unexplained reason, we were not invited" to the National
Committee to Review Current Procedures for Approval of New Drugs for
Cancer & AIDS press conference, FDA Center for Drug Evaluation & Research
director Carl Peck says. Nor was FDA invited to the White House reportpresentation ceremony, he noted. "Bush should have thanked" FDA scientists
-- as he did National Cancer Institute's Sam Broder.
"We didn't even get permission to speak (to the media) until almost 6
o'clock" Wednesday evening, after the committee's morning press
conference. So Peck called his own trade-press "briefing" the next day.
And speak he did.
"We don't understand the motivation behind some of the recommendations,"
Peck said. "Significant misunderstandings in the report make us
wonder..The report is conspicuously void of data...Simply an uneducated
critique...Some suggest the report could have been written before hearings
were held. It's up to you to look into the motivation and funding of the
committee."
While he was at it, Peck took a swipe or two at industry sponsors: He
praised an FDA scientist "who rescued flawed drug development programs."
The Lasagna report "fails to note flawed industry and sister agency"
actions. NDA review time "is utterly dependent upon the quality" of
sponsors' applications.

Enough of the pleasantries. Peck really didn't like the report.