Newsletter Vol.32, no. 32

Nesete

Pharmaceutical
Manufacturers
Association
Editor: Duffy Miller

N u m b e r 3 2 1 1 1 1 1 1 I 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 I I ( 2 0 2 ) 8 3 5 - 3 4 6 8
Volume 32, Number 3 1 N um109.54031 ier 32 5571095t~~~~~~~~ ~2n2~ln s.05~m~~m04.023
August 20, 1990
RAIDS ON NDA REVIEWERS TO STAFF GENERICS COULD ESCALATE, PECK SAYS
So far, "the extent of the raid" on NDA staff to help expedite generic
approvals has been "modest, only a handful" of chemists and other
reviewers, Center for Drug Evaluation & Research director Carl Peck said
last week.
"However, (under) increasing pressure -- urgency -- to solve the backlog
of ANDAs, we are contemplating expansion" of the shifts. Some NDE
programs could be identified as "having been slowed."
Peck described "the tug and pull of deciding what is more important:
pushing new drugs through" or increasing the number of generics.
"We will do everything we can (to protect) AIDS and cancer (NDAs), but I
can't assure any other" new drug divisions will not be hurt.
NO STOPGAP MEASURES, LASAGNA COMMITTEE RECOMMENDS BASIC FDA CHANGES
President George Bush took time from the Middle East and budget crises
last Wednesday to meet with Armand Hammer. Hammer, titular head of the
National Committee to Review Current Procedures for Approval of New Drugs
for Cancer & AIDS, presented Bush with his committee's final report. (The
study responded to a 1988 request from then-Vice President George Bush,
acting as chairman of the Presidential Task Force on Regulatory Relief.
The committee's name defines its purpose.)
Hammer, committee chairman Louis Lasagna and National Cancer Institute's
Samuel Broder then discussed their findings with the press.
"We attempted to identify barriers to rapid availability" of new AIDS and
cancer therapies, Lasagna told reporters. And there is "definite
progress," he continued: "closer cooperation between FDA and NIH," "a
closer FDA-commercial sponsor working relationship," and "increased
flexibility on endpoints."
But, Lasagna later said, "FDA is inconsistent on accepting surrogate
endpoints" and while the agency publicly maintains that sponsors are
responsible for slow approvals, in private some admit "it is not true that
the only problem is filing."
Basic, formal changes are needed to expedite approval of cancer and AIDS
therapies, the committee felt. It recommended these:

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