Newsletter Vol.32, no. 32

PMA NEWSLETTER

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August 20, 1990

o A Permanent Policy & Oversight Committee, appointed by and reporting
to the Secretary of Health & Human Services, should be established to
monitor FDA needs and performance with regard to regulation of drugs and
biologics for human use.
o A National Policy to foster development of new drugs for AIDS & cancer
to meet the needs for all patients who suffer from these diseases.
o Expediting Approval of Important New Drugs. FDA should continue to
exercise its statutory and administrative flexibility to approve AIDS &
cancer drugs for marketing at the earliest possible point in their
development.
o Standard for Effectiveness. FDA should pay particular attention to
the statutory definition of "substantial evidence" of effectiveness, which
reflects the intent of Congress that new drugs be approved for marketing
on the basis of the scientific judgment of qualified experts that
sufficient clinical data exist to demonstrate therapeutic benefit.
o Surrogate Endpoints in Clinical Trials. Progress has been made, but
additional work and consultation is needed to reach further agreement in
this area.
o Community-Based Clinical Trials that permit widespread access to
investigational drugs without sacrificing statistical analysis of drug
effectiveness should be developed and encouraged.
o Relationship Between FDA and Drug Sponsors. Drug sponsors bear the
burden of submitting IND plans, conducting clinical trials, and preparing
NDAs in an efficient & competent manner to help expedite approval of
important new drugs. More open discussion between FDA and drug sponsors,
and involvement of advisory committees where appropriate, is needed to
avoid misunderstanding about FDA guidance on clinical trials. The
relationship between FDA and drug sponsors must be informal, highly
interactive and foster a spirit of mutual cooperation if drug development
and approval are to proceed expeditiously.
o FDA Advisory Committees. A fundamental restructuring of the FDA
advisory committee system is needed, under which all advisory committees
would have their own independent staff located in the Office of the FDA
Commissioner, would be responsible for their own agenda, and would more
closely monitor the progress of the new drug approval system.
o IRB Review of Clinical Studies. To promote increased study of
potential drug treatments in humans, sponsors should have the right to
select, as an option, submitting an IND for a phase I clinical study for
review by an institutional review board (IRB) rather than by FDA.
To reduce FDA burdens, phase I and phase II noncommercial clinical
research aimed at finding new uses for marketed drugs should also be
handled through review by an IRB in lieu of FDA review.
o Reduction of FDA Clinical Holds. FDA should reduce both formal and
informal clinical holds on INDs to the minimum needed to assure human
safety.

o Treatment IND. FDA is commended for codifying the treatment IND in
published regulations, which should be implemented in a more flexible way