PI Action alerts & updates ... 1996
TAN ALERT: Project Inform Salutes FDA Commissioner Kessler for
a Job Well Done
November 25, 1996
“With today’s announcement that Dr. David Kessler will
resign as head of the Food and Drug Administration, people with
AIDS and all others who sought meaningful reform at the FDA have
lost a friend,” said Martin Delaney, Founding Director of
Project Inform, a nationally known AIDS information and advocacy
bureau. Delaney continued “Kessler didn’t just talk
about speeding up the approval of new drugs, he reorganized the
agency to make it happen. Without him, there would be little of
the hope felt today over recent advances in AIDS treatments because
those new drugs would not yet be available.”
Kessler had worked with AIDS advocates from the very beginning
of his reign at the agency to speed up the FDA’s processing
of applications for critically needed new drugs. While he was sometimes
criticized for not moving quite as quickly in other areas, such
as medical devices and biological products, most AIDS groups felt
he struck a productive balance between faster approvals and maintaining
public safety. “Kessler will be remembered for routinely reducing
the time of a drug approval review from years to a few short months.
It’s an impressive legacy and we believe that many people
owe him credit for helping extend their lives,” said Ben Cheng,
also of Project Inform.
Kessler has come under fire in recent years for his challenges
to the tobacco industry. Some pharmaceutical industry groups have
also tried to promote even wider reduction of drug regulations,
but Kessler held his ground, arguing that the public safety still
demanded careful review of new drug and medical device applications.
“Many of Kessler’s harshest critics were, at some level,
found to be linked to the tobacco industry,” Delaney said.
Project Inform acknowledged that it has had productive relations
with the agency, and with Dr. Kessler in particular, since he was
appointed. “One of the remaining challenges of FDA reform,”
said Ben Cheng, “is to make many of the advances pioneered
in AIDS more evenly available to other life-threatening illnesses.
The AIDS experience proved that it was possible to greatly accelerate
the approval process without endangering the public safety. That
same standard must be applied to any further reform.”
Delaney said that his agency, and many similar AIDS groups, are
greatly concerned about who will replace Kessler. “The job
demands someone who can stand up to the pressures of industry and
hold the line on public safety. I wonder whether the current Congress
will approve a candidate who measures up to that test,” said
Delaney. Project Inform urged the president and the Congress to
view this appointment as one of the most critical personnel choices
to be made by the new administration.
