Fugazi,
This is the one you read.
WSJ 6/26
The Wrong Choice for the FDA
By HENRY I. MILLER
The Food and Drug Administration has been without a
commissioner since David Kessler's departure in
February 1997. Even in the best of times, it is a difficult
job to fill. The press of issues ranging from drug
approvals and recalls to food safety makes it grueling;
the pay is far less than top candidates can command in
the private sector; and former commissioners have not
typically advanced to better jobs.
Jane Henney, vice president of the University of New
Mexico's Health Sciences Center and a former FDA
deputy commissioner, was nominated for the top job
Wednesday. Dr. Henney is a quintessential Clinton
choice: a true believer in arrogant, intrusive,
damn-the-expenses government regulation. While she
was deputy commissioner (1992-94), the regulatory
burden on drug companies grew. The drug-development
system in the U.S. has become the slowest and most
expensive in the world, with development times more
than doubling to almost 15 years since 1964, and the
average cost of developing a single drug rising to more
than $500 million from $359 million just between 1990
and 1993.
The agency's scope is so sweeping
(encompassing, among other things,
cardiac pacemakers, X-ray machines,
condoms, home pregnancy-testing kits,
drugs, vaccines, artificial sweeteners
and fat substitutes) that a single person
cannot be expected to master the body
of science, medicine, pharmacology
and engineering involved. Beyond
those areas there is also "regulatory
science" and law. The FDA's
professional staff frames the issues and options, while
the agency head sets the overall tenor, manages the
far-flung empire and makes the final decisions on
difficult policy questions.
The FDA commissioner's management and
decision-making must meld law, science, medicine and
regulatory precedents in a way that maximizes the public
interest. The agency head needs to earn the respect of
those who have a stake in the FDA's policies and
decisions--patient groups, individual consumers, drug
companies and Congress--through candor and
consistency. But as deputy commissioner, Dr. Henney
was considered unapproachable and intransigent by both
industry and her colleagues.
What's more, her decisions often appeared to be
motivated by politics. As co-chairman of the Public
Health Service Task Force on Breast Implants in 1992,
Dr. Henney collaborated prominently in the disastrous
government decisions that needlessly left millions of
women fearful and confused and that destroyed the
silicone-implant industry. As an FDA official, Dr.
Henney was willing to delay the approval of certain
politically incorrect products (bovine somatotropin, a
protein that enhances milk production, opposed by Vice
President Al Gore and his staff) and to expedite others
(a female condom with dubious efficacy, lauded as a
"feminist" product by Health and Human Services
Secretary Donna Shalala).
The next FDA commissioner must be committed to
regulatory reform. The FDA needs to streamline its
existing regulatory procedures and requirements in ways
that will significantly cut the time and costs of drug
development. The agency's managers must be made more
accountable for their decisions, especially when they
delay important new drugs, vaccines and medical
devices. But during her tenure at the FDA, Dr. Henney,
who supervised all of the agency's operating divisions
(which oversee clinical testing, review and approve
products, ensure compliance with regulations, monitor
side effects and issue product recalls), showed no sign
of perceiving the need for reform.
Indeed, a congressional effort at substantial reform was
sabotaged last year by the very senator who is
championing Dr. Henney's nomination, Edward M.
Kennedy (D., Mass.). Dr. Henney's husband, Robert
Graham, is a liberal health-care lobbyist and a former
Kennedy aide.
The FDA commissioner should be insulated from
politics and willing to take the heat for unpopular
decisions. Dr. Henney was invariably willing to go
along to get along. She capitulated to the White House
not only on matters of policy (which may be
appropriate), but also on decisions that concerned
individual products and personnel. When the Clinton
administration took over in 1993, Dr. Henney shuffled
civil servants around on instructions from Mr. Gore's
staff, a contravention of civil service regulations.
The FDA regulates products accounting for
approximately 25 cents of every consumer dollar--worth
more than $1 trillion annually. Milton Friedman has
observed that some government agencies interfere in the
free market because they mistrust freedom itself. Dr.
Henney has helped make the FDA into such an agency.
The Senate should reject her nomination lest she further
politicize the powerful agency.
Dr. Miller is a senior research fellow at Stanford
University's Hoover Institution and the author of "Policy
Controversy in Biotechnology: An Insider's View" (R.G.
Landes Co., 1997). From 1979 to 1994 he held various
positions at the FDA. |
