Newsletter Vol.32, no. 32

PMA NEWSLETTER

- 4 -

August 20, 1990

Then-Vice President George Bush, as chairman of the Presidential Task
Force on Regulatory Reform, asked President's Cancer Panel head Armand
Hammer to form the committee in 1988. Bush wanted "a systematic study of
drug regulation as it affects progress in developing and making available
therapies for cancer and AIDS, and...recommendations for improvements."
That's what it contained, and Peck didn't like it. (He wanted paeans to
FDA: "There is so little allusion to our excellent record.")
"Wholesale revamping of the advisory committee system," to give advisors
more independence, one report recommendation, exemplifies the committee's
"significant misunderstanding" of the system established by law, Peck
said. He dismissed a reporter's suggestion that perhaps this responded
to charges of advisory committee manipulation by the groups' FDA executive
secretaries. They "normally have administrative functions only," Peck
said -- setting up meetings, sending out notices, etc. "They're not in
a position to swing votes."
Outside review of Phase I data -- another Lasagna committee report
recommendation -- "flies in the face" of the Bush Initiative (expedited
review procedures), which calls for more FDA involvement in Phase I
studies, Peck said. Response to a recent Federal Register request for
comments on Institutional Review Board review was "overwhelmingly negative...persuaded us IRBs will not accept" the job. He didn't like the idea
of other outside-expert reviewers either. "Cancer and AIDS drug review
times would be expanded significantly," he predicted.
Definite surrogate endpoints urged by the committee report were also
rejected. "It's a very complex and controversial subject...as reflected
in advisory committee meetings," Peck said.
In fact, Peck disagreed with practically all committee recommendations.
He didn't mind insurance coverage for investigational drugs. "It's out
of our domain. We would have no objection, and it might make our lives
a little easier."
Even the call for more FDA resources met with only grudging approval:
"It was their last recommendation," Peck said.
"About 30 panels have examined FDA over the past several decades," Peck
said. "They were not unwelcome. We value the opportunity to explain our
mission and how we do it." He said nothing about the agency's reaction
to criticism....AND PMA RESPONSE TO THE REPORT
PMA said this about the final report of the national committee to review
current procedures for approval of new drugs for cancer and AIDS:
"PMA supports the recommendations for changes to the nation's drug
approval system contained in the final report of the National Committee
to Review Current Procedures for Approval of New Drugs for Cancer &
AIDS.
"We hope FDA will move quickly to adopt these recommendations, not just
for AIDS, cancer and other life-threatening conditions, but for all new

drugs. Clearly it is in the interest of patients to have medicines made
available more quickly in the United States.